Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST ...
FDA Device Recall #Z-2027-2026 — Class II — March 19, 2026
Recall Summary
| Recall Number | Z-2027-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 19, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 263739 kits |
Product Description
Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.
Reason for Recall
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Distribution Pattern
Worldwide distribution.
Lot / Code Information
Medline Kit Number/SKU BIOB110: UDI/DI each 10889942758043, UDI/DI case 40889942758044, Lot Number: 24HBM826; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23KBK939; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23JBD164; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23HBJ252; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23EBV328; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23DBD983; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23BBR624; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23BBM647; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23BBB199; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23ABR879; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 23ABK516; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22KBO464; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22IBD725; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22FBH811; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22DBG358; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22CBS385; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 22ABG822; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 24CBK278; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 24CBG921; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 24BBM090; Medline Kit Number/SKU CDS780056M: UDI/DI each 10195327045562, UDI/DI case 40195327045563, Lot Number: 24ABK179; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 26ABC519; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25JBY144; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25GBU677; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25FBK528; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25EBM571; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25DBA260; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 25BBD145; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 24KBA043; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 24JBQ514; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 24JBE904; Medline Kit Number/SKU CDS780056N: UDI/DI each 10195327645533, UDI/DI case 40195327645534, Lot Number: 24HBT002; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 23ABC251; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 23ABA109; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22LBG189; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22JBH395; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22IBH148; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22IBH149; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22HBK033; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22FBP720; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22EBF677; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 22EBE578; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 21KBC814; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 21IBG791; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 21GBM673; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 21EBN323; Medline Kit Number/SKU CDS840490K: UDI/DI each 10193489434811, UDI/DI case 40193489434812, Lot Number: 21EBE906; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 23IBL699; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 23IBF324; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 23HBK824; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 23HBI027; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 23FBB361; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 23DBH603; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 23CBP031; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 23BBT911; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 22KBJ589; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 22IBW083; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 22IBU661; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 22IBP415; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 22HBH503; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 22DBJ059; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 22BBS783; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 21LBE720; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 21IBX894; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 21HBF776; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 21GBU819; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 21FBS280; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 21EBM597; Medline Kit Number/SKU CDS980523L: UDI/DI each 10889942969951, UDI/DI case 40889942969952, Lot Number: 21BBI896; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 23HBV227; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 23EBX115; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 23EBA159; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 23CBS045; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 23BBB544; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 22LBJ560; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 22KBJ947; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 22GBD058; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 21LBX363; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 21LBB483; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 21GBP339; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 21FBA018; Medline Kit Number/SKU CDS980524I: UDI/DI each 10889942969357, UDI/DI case 40889942969358, Lot Number: 21DBO221; Medline Kit Number/SKU CDS982683X: UDI/DI each 10198459064548, UDI/DI case 40198459064549, Lot Number: 25LBQ249; Medline Kit Number/SKU CDS982683X: UDI/DI each 10198459064548, UDI/DI case 40198459064549, Lot Number: 25JBE076; Medline Kit Number/SKU CDS982683X: UDI/DI each 10198459064548, UDI/DI case 40198459064549, Lot Number: 25IBH078; Medline Kit Number/SKU CDS982683X: UDI/DI each 10198459064548, UDI/DI case 40198459064549, Lot Number: 25HBJ526; Medline Kit Number/SKU CDS982683X: UDI/DI each 10198459064548, UDI/DI case 40198459064549, Lot Number: 25FBC545; Medline Kit Number/SKU CDS982683X: UDI/DI each 10198459064548, UDI/DI case 40198459064549, Lot Number: 25ABM594; Medline Kit Number/SKU CDS982683X: UDI/DI each 10198459064548, UDI/DI case 40198459064549, Lot Number: 25ABB924; Medline Kit Number/SKU CDS982683X: UDI/DI each 10198459064548, UDI/DI case 40198459064549, Lot Number: 24JBC331; Medline Kit Number/SKU CDS982683X: UDI/DI each 10198459064548, UDI/DI case 40198459064549, Lot Number: 24JBC484; Medline Kit Number/SKU CDS982719X: UDI/DI each 10198459064531, UDI/DI case 40198459064532, Lot Number: 24LBC587; Medline Kit Number/SKU CDS982719X: UDI/DI each 10198459064531, UDI/DI case 40198459064532, Lot Number: 24KBA129; Medline Kit Number/SKU CDS982719X: UDI/DI each 10198459064531, UDI/DI case 40198459064532, Lot Number: 24JBB766; Medline Kit Number/SKU CDS982719X: UDI/DI each 10198459064531, UDI/DI case 40198459064532, Lot Number: 24IBE288; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 23GBE103; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 23FBE548; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 23EBG901; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 23DBK554; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 23CBQ213; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 23CBI598; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 23BBB052; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 22JBR311; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 22IBR028; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 22GBT501; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 22EBR711; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 22ABV552; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 21LBG293; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 21KBK303; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 21IBM889; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 21HBR421; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 21HBH158; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 21FBO800; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 21ABO348; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 25EBK027; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 25CBO693; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 25CBA832; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 25ABU727; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 24JBG302; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 24IBE056; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 24HBL951; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 24EBQ434; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 24DBT201; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 24CBS697; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 23LBT931; Medline Kit Number/SKU CDS982744G: UDI/DI each 10193489490411, UDI/DI case 40193489490412, Lot Number: 23LBK969; Medline Kit Number/SKU CDS982939V: UDI/DI each 10198459606786, UDI/DI case 40198459606787, Lot Number: 26ABG183; Medline Kit Number/SKU CDS983067N: UDI/DI each 10889942773176, UDI/DI case 40889942773177, Lot Number: 21EBA120; Medline Kit Number/SKU CDS983067N: UDI/DI each 10889942773176, UDI/DI case 40889942773177, Lot Number: 21CBX335; Medline Kit Number/SKU CDS983067N: UDI/DI each 10889942773176, UDI/DI case 40889942773177, Lot Number: 21CBV928; Medline Kit Number/SKU CDS983100C: UDI/DI each 10889942926763, UDI/DI case 40889942926764, Lot Number: 23KBR559; Medline Kit Number/SKU CDS983100C: UDI/DI each 10889942926763, UDI/DI case 40889942926764, Lot Number: 23JBX007; Medline Kit Number/SKU CDS983100C: UDI/DI each 10889942926763, UDI/DI case 40889942926764, Lot Number: 23IBH915; Medline Kit Number/SKU CDS983100C: UDI/DI each 10889942926763, UDI/DI case 40889942926764, Lot Number: 23FBO476; Medline Kit Number/SKU CDS983100C: UDI/DI each 10889942926763, UDI/DI case 40889942926764, Lot Number: 23BBG694; Medline Kit Number/SKU CDS983100C: UDI/DI each 10889942926763, UDI/DI case 40889942926764, Lot Number: 23ABI070; Medline Kit Number/SKU CDS983100C: UDI/DI each 10889942926763, UDI/DI case 40889942926764, Lot Number: 22JBB204; Medline Kit Number/SKU CDS983100C: UDI/DI each 10889942926763, UDI/DI case 40889942926764, Lot Number: 22EBK343; Medline Kit Number/SKU CDS983100C: UDI/DI each 10889942926763, UDI/DI case 40889942926764, Lot Number: 22DBJ569; Medline Kit Number/SKU CDS983100C: UDI/DI each 10889942926763, UDI/DI case 40889942926764, Lot Number: 22BBD220; Medline Kit Number/SKU CDS983100C: UDI/DI each 10889942926763, UDI/DI case 40889942926764, Lot Number: 21IBO785; Medline Kit Number/SKU CDS983100C: UDI/DI each 10889942926763, UDI/DI case 40889942926764, Lot Number: 21IBE971; Medline Kit Number/SKU CDS983100C: UDI/DI each 10889942926763, UDI/DI case 40889942926764, Lot Number: 21HBE589; Medline Kit Number/SKU CDS983100C: UDI/DI each 10889942926763, UDI/DI case 40889942926764, Lot Number: 21EBB759; Medline Kit Number/SKU CDS983100C: UDI/DI each 10889942926763, UDI/DI case 40889942926764, Lot Number: 21ABQ834; Medline Kit Number/SKU CDS983100C: UDI/DI each 10889942926763, UDI/DI case 40889942926764, Lot Number: 24BBT244; Medline Kit Number/SKU CDS983100C: UDI/DI each 10889942926763, UDI/DI case 40889942926764, Lot Number: 23LBD710; Medline Kit Number/SKU CDS983115J: UDI/DI each 10198459479861, UDI/DI case 40198459479862, Lot Number: 25JBN156; Medline Kit Number/SKU CDS983157J: UDI/DI each 10889942918942, UDI/DI case 40889942918943, Lot Number: 22LBS780; Medline Kit Number/SKU CDS983157J: UDI/DI each 10889942918942, UDI/DI case 40889942918943, Lot Number: 22GBT591; Medline Kit Number/SKU CDS983157J: UDI/DI each 10889942918942, UDI/DI case 40889942918943, Lot Number: 22DBN752; Medline Kit Number/SKU CDS983157J: UDI/DI each 10889942918942, UDI/DI case 40889942918943, Lot Number: 22BBD240; Medline Kit Number/SKU CDS983157J: UDI/DI each 10889942918942, UDI/DI case 40889942918943, Lot Number: 21JBJ724; Medline Kit Number/SKU CDS983157J: UDI/DI each 10889942918942, UDI/DI case 40889942918943, Lot Number: 21IBW688; Medline Kit Number/SKU CDS983157J: UDI/DI each 10889942918942, UDI/DI case 40889942918943, Lot Number: 21GBS220; Medline Kit Number/SKU CDS983178J: UDI/DI each 10198459038280, UDI/DI case 40198459038281, Lot Number: 26CBD500; Medline Kit Number/SKU CDS983178J: UDI/DI each 10198459038280, UDI/DI case 40198459038281, Lot Number: 25LBS105; Medline Kit Number/SKU CDS983178J: UDI/DI each 10198459038280, UDI/DI case 40198459038281, Lot Number: 25KBS363; Medline Kit Number/SKU CDS983178J: UDI/DI each 10198459038280, UDI/DI case 40198459038281, Lot Number: 25IBM044; Medline Kit Number/SKU CDS983178J: UDI/DI each 10198459038280, UDI/DI case 40198459038281, Lot Number: 25HBD677; Medline Kit Number/SKU CDS983178J: UDI/DI each 10198459038280, UDI/DI case 40198459038281, Lot Number: 25GBK352; Medline Kit Number/SKU CDS983178J: UDI/DI each 10198459038280, UDI/DI case 40198459038281, Lot Number: 25FBQ301; Medline Kit Number/SKU CDS983178J: UDI/DI each 10198459038280, UDI/DI case 40198459038281, Lot Number: 25EBK283; Medline Kit Number/SKU CDS983178J: UDI/DI each 10198459038280, UDI/DI case 40198459038281, Lot Number: 25CBR564; Medline Kit Number/SKU CDS983178J: UDI/DI each 10198459038280, UDI/DI case 40198459038281, Lot Number: 25BBI028; Medline Kit Number/SKU CDS983178J: UDI/DI each 10198459038280, UDI/DI case 40198459038281, Lot Number: 25ABM403; Medline Kit Number/SKU CDS983188L: UDI/DI each 10198459038266, UDI/DI case 40198459038267, Lot Number: 24JBC920; Medline Kit Number/SKU CDS983188L: UDI/DI each 10198459038266, UDI/DI case 40198459038267, Lot Number: 24IBU234; Medline Kit Number/SKU CDS983188L: UDI/DI each 10198459038266, UDI/DI case 40198459038267, Lot Number: 24IBC919; Medline Kit Number/SKU CDS983188L: UDI/DI each 10198459038266, UDI/DI case 40198459038267, Lot Number: 24GBQ536; Medline Kit Number/SKU CDS983467J: UDI/DI each 10195327561116, UDI/DI case 40195327561117, Lot Number: 26BDA647; Medline Kit Number/SKU CDS983467J: UDI/DI each 10195327561116, UDI/DI case 40195327561117, Lot Number: 25KDA428; Medline Kit Number/SKU CDS983467J: UDI/DI each 10195327561116, UDI/DI case 40195327561117, Lot Number: 25JDB968; Medline Kit Number/SKU CDS983467J: UDI/DI each 10195327561116, UDI/DI case 40195327561117, Lot Number: 25IDB107; Medline Kit Number/SKU CDS983467J: UDI/DI each 10195327561116, UDI/DI case 40195327561117, Lot Number: 25IDA400; Medline Kit Number/SKU CDS983467J: UDI/DI each 10195327561116, UDI/DI case 40195327561117, Lot Number: 25FDB668; Medline Kit Number/SKU CDS983467J: UDI/DI each 10195327561116, UDI/DI case 40195327561117, Lot Number: 25FDA381; Medline Kit Number/SKU CDS983467J: UDI/DI each 10195327561116, UDI/DI case 40195327561117, Lot Number: 25EDA472; Medline Kit Number/SKU CDS983467J: UDI/DI each 10195327561116, UDI/DI case 40195327561117, Lot Number: 25DDB795; Medline Kit Number/SKU CDS983470I: UDI/DI each 10195327561154, UDI/DI case 40195327561155, Lot Number: 26ADB825; Medline Kit Number/SKU CDS983470I: UDI/DI each 10195327561154, UDI/DI case 40195327561155, Lot Number: 25LDA344; Medline Kit Number/SKU CDS983470I: UDI/DI each 10195327561154, UDI/DI case 40195327561155, Lot Number: 25JDA353; Medline Kit Number/SKU CDS983470I: UDI/DI each 10195327561154, UDI/DI case 40195327561155, Lot Number: 25HDA472; Medline Kit Number/SKU CDS983470I: UDI/DI each 10195327561154, UDI/DI case 40195327561155, Lot Number: 25GDA464; Medline Kit Number/SKU CDS983470I: UDI/DI each 10195327561154, UDI/DI case 40195327561155, Lot Number: 25EDB386; Medline Kit Number/SKU CDS983470I: UDI/DI each 10195327561154, UDI/DI case 40195327561155, Lot Number: 25DDA691; Medline Kit Number/SKU CDS983799D: UDI/DI each 10193489592030, UDI/DI case 40193489592031, Lot Number: 23HLA184; Medline Kit Number/SKU CDS983799D: UDI/DI each 10193489592030, UDI/DI case 40193489592031, Lot Number: 22ILA292; Medline Kit Number/SKU CDS983799D: UDI/DI each 10193489592030, UDI/DI case 40193489592031, Lot Number: 22ILA060; Medline Kit Number/SKU CDS984227A: UDI/DI each 10889942932092, UDI/DI case 40889942932093, Lot Number: 21DBO013; Medline Kit Number/SKU CDS984227A: UDI/DI each 10889942932092, UDI/DI case 40889942932093, Lot Number: 21CBH552; Medline Kit Number/SKU CDS984227A: UDI/DI each 10889942932092, UDI/DI case 40889942932093, Lot Number: 21CBG290; Medline Kit Number/SKU CDS984227A: UDI/DI each 10889942932092, UDI/DI case 40889942932093, Lot Number: 21BBN543; Medline Kit Number/SKU CDS984227A: UDI/DI each 10889942932092, UDI/DI case 40889942932093, Lot Number: 21BBI020; Medline Kit Number/SKU CDS984229I: UDI/DI each 10889942841882, UDI/DI case 40889942841883, Lot Number: 21CBY137; Medline Kit Number/SKU CDS984260K: UDI/DI each 10198459303005, UDI/DI case 40198459303006, Lot Number: 26ABD722; Medline Kit Number/SKU CDS984260K: UDI/DI each 10198459303005, UDI/DI case 40198459303006, Lot Number: 25LBR536; Medline Kit Number/SKU CDS984260K: UDI/DI each 10198459303005, UDI/DI case 40198459303006, Lot Number: 25KBQ910; Medline Kit Number/SKU CDS984260K: UDI/DI each 10198459303005, UDI/DI case 40198459303006, Lot Number: 25JBN593; Medline Kit Number/SKU CDS984260K: UDI/DI each 10198459303005, UDI/DI case 40198459303006, Lot Number: 25IBE140; Medline Kit Number/SKU CDS984260K: UDI/DI each 10198459303005, UDI/DI case 40198459303006, Lot Number: 25HBH826; Medline Kit Number/SKU CDS984260K: UDI/DI each 10198459303005, UDI/DI case 40198459303006, Lot Number: 25EBM971; Medline Kit Number/SKU CDS984260K: UDI/DI each 10198459303005, UDI/DI case 40198459303006, Lot Number: 25DBM368; Medline Kit Number/SKU CDS984263N: UDI/DI each 10198459303104, UDI/DI case 40198459303105, Lot Number: 26BBQ554; Medline Kit Number/SKU CDS984263N: UDI/DI each 10198459303104, UDI/DI case 40198459303105, Lot Number: 26BBC142; Medline Kit Number/SKU CDS984263N: UDI/DI each 10198459303104, UDI/DI case 40198459303105, Lot Number: 25LBU831; Medline Kit Number/SKU CDS984263N: UDI/DI each 10198459303104, UDI/DI case 40198459303105, Lot Number: 25GBR902; Medline Kit Number/SKU CDS985212B: UDI/DI each 10193489779820, UDI/DI case 40193489779821, Lot Number: 21FBC646; Medline Kit Number/SKU CDS985212B: UDI/DI each 10193489779820, UDI/DI case 40193489779821, Lot Number: 21CBJ230; Medline Kit Number/SKU CDS985227B: UDI/DI each 10198459466236, UDI/DI case 40198459466237, Lot Number: 25LBR278; Medline Kit Number/SKU CDS985227B: UDI/DI each 10198459466236, UDI/DI case 40198459466237, Lot Number: 25LBH234; Medline Kit Number/SKU CDS985227B: UDI/DI each 10198459466236, UDI/DI case 40198459466237, Lot Number: 25LBD494; Medline Kit Number/SKU CDS985227B: UDI/DI each 10198459466236, UDI/DI case 40198459466237, Lot Number: 25JBX546; Medline Kit Number/SKU DYKM1073A: UDI/DI each 10889942809851, UDI/DI case 40889942809852, Lot Number: 21CMB378; Medline Kit Number/SKU DYKMBNDL32C: UDI/DI each 10198459111488, UDI/DI case 40198459111489, Lot Number: 26BBE723; Medline Kit Number/SKU DYKMBNDL32C: UDI/DI each 10198459111488, UDI/DI case 40198459111489, Lot Number: 25LBL101; Medline Kit Number/SKU DYKMBNDL32C: UDI/DI each 10198459111488, UDI/DI case 40198459111489, Lot Number: 25KBN534; Medline Kit Number/SKU DYKMBNDL32C: UDI/DI each 10198459111488, UDI/DI case 40198459111489, Lot Number: 25KBC732; Medline Kit Number/SKU DYKMBNDL32C: UDI/DI each 10198459111488, UDI/DI case 40198459111489, Lot Number: 25JBD565; Medline Kit Number/SKU DYKMBNDL32C: UDI/DI each 10198459111488, UDI/DI case 40198459111489, Lot Number: 25IBN626; Medline Kit Number/SKU DYKMBNDL32C: UDI/DI each 10198459111488, UDI/DI case 40198459111489, Lot Number: 25HBO192; Medline Kit Number/SKU DYKMBNDL32C: UDI/DI each 10198459111488, UDI/DI case 40198459111489, Lot Number: 25GBV912; Medline Kit Number/SKU DYKMBNDL32C: UDI/DI each 10198459111488, UDI/DI case 40198459111489, Lot Number: 24IBR627; Medline Kit Number/SKU DYKMBNDL32C: UDI/DI each 10198459111488, UDI/DI case 40198459111489, Lot Number: 24IBR628; Medline Kit Number/SKU DYKMBNDL32C: UDI/DI each 10198459111488, UDI/DI case 40198459111489, Lot Number: 24IBJ615; Medline Kit Number/SKU DYKMBNDL32C: UDI/DI each 10198459111488, UDI/DI case 40198459111489, Lot Number: 24IBJ810; Medline Kit Number/SKU DYNDA2085A: UDI/DI each 10888277755215, UDI/DI case 40888277755216, Lot Number: 23FMB872; Medline Kit Number/SKU DYNDA2085A: UDI/DI each 10888277755215, UDI/DI case 40888277755216, Lot Number: 23AMJ425; Medline Kit Number/SKU DYNDA2085A: UDI/DI each 10888277755215, UDI/DI case 40888277755216, Lot Number: 22FBC683; Medline Kit Number/SKU DYNDA2085A: UDI/DI each 10888277755215, UDI/DI case 40888277755216, Lot Number: 21LBY831; Medline Kit Number/SKU DYNDA2085A: UDI/DI each 10888277755215, UDI/DI case 40888277755216, Lot Number: 25AME167; Medline Kit Number/SKU DYNDA2085A: UDI/DI each 10888277755215, UDI/DI case 40888277755216, Lot Number: 24BMF305; Medline Kit Number/SKU DYNDA2085A: UDI/DI each 10888277755215, UDI/DI case 40888277755216, Lot Number: 23LMC729; Medline Kit Number/SKU DYNJ0045920C: UDI/DI each 10193489603385, UDI/DI case 40193489603386, Lot Number: 22GMF143; Medline Kit Number/SKU DYNJ0045920C: UDI/DI each 10193489603385, UDI/DI case 40193489603386, Lot Number: 22FMG468; Medline Kit Number/SKU DYNJ0045920C: UDI/DI each 10193489603385, UDI/DI case 40193489603386, Lot Number: 22FMA092; Medline Kit Number/SKU DYNJ0045920C: UDI/DI each 10193489603385, UDI/DI case 40193489603386, Lot Number: 21LMC098; Medline Kit Number/SKU DYNJ0045920C: UDI/DI each 10193489603385, UDI/DI case 40193489603386, Lot Number: 21KMA617; Medline Kit Number/SKU DYNJ0045920C: UDI/DI each 10193489603385, UDI/DI case 40193489603386, Lot Number: 21IMB310; Medline Kit Number/SKU DYNJ0045920C: UDI/DI each 10193489603385, UDI/DI case 40193489603386, Lot Number: 21GMG042; Medline Kit Number/SKU DYNJ0045920C: UDI/DI each 10193489603385, UDI/DI case 40193489603386, Lot Number: 21GMA906; Medline Kit Number/SKU DYNJ0045920C: UDI/DI each 10193489603385, UDI/DI case 40193489603386, Lot Number: 21BMC630; Medline Kit Number/SKU DYNJ0101287M: UDI/DI each 10198459119491, UDI/DI case 40198459119492, Lot Number: 25BMC014; Medline Kit Number/SKU DYNJ0101287M: UDI/DI each 10198459119491, UDI/DI case 40198459119492, Lot Number: 24KDB258; Medline Kit Number/SKU DYNJ0101287M: UDI/DI each 10198459119491, UDI/DI case 40198459119492, Lot Number: 24JDA631; Medline Kit Number/SKU DYNJ0101287N: UDI/DI each 10198459299902, UDI/DI case 40198459299903, Lot Number: 25GMC900; Medline Kit Number/SKU DYNJ0101287N: UDI/DI each 10198459299902, UDI/DI case 40198459299903, Lot Number: 25EMF066; Medline Kit Number/SKU DYNJ0101287N: UDI/DI each 10198459299902, UDI/DI case 40198459299903, Lot Number: 25DMJ594; Medline Kit Number/SKU DYNJ0101287N: UDI/DI each 10198459299902, UDI/DI case 40198459299903, Lot Number: 25DMA045; Medline Kit Number/SKU DYNJ0101287O: UDI/DI each 10198459454158, UDI/DI case 40198459454159, Lot Number: 26CMB207; Medline Kit Number/SKU DYNJ0101287O: UDI/DI each 10198459454158, UDI/DI case 40198459454159, Lot Number: 25JMC824; Medline Kit Number/SKU DYNJ0101287O: UDI/DI each 10198459454158, UDI/DI case 40198459454159, Lot Number: 25IMI888; Medline Kit Number/SKU DYNJ0101287O: UDI/DI each 10198459454158, UDI/DI case 40198459454159, Lot Number: 25IMC815; Medline Kit Number/SKU DYNJ0101292I: UDI/DI each 10198459119064, UDI/DI case 40198459119065, Lot Number: 24LDA883; Medline Kit Number/SKU DYNJ0101292I: UDI/DI each 10198459119064, UDI/DI case 40198459119065, Lot Number: 24KDB872; Medline Kit Number/SKU DYNJ0101292I: UDI/DI each 10198459119064, UDI/DI case 40198459119065, Lot Number: 24JDA749; Medline Kit Number/SKU DYNJ0101292J: UDI/DI each 10198459299926, UDI/DI case 40198459299927, Lot Number: 26BDA781; Medline Kit Number/SKU DYNJ0101292J: UDI/DI each 10198459299926, UDI/DI case 40198459299927, Lot Number: 25LDA756; Medline Kit Number/SKU DYNJ0101292J: UDI/DI each 10198459299926, UDI/DI case 40198459299927, Lot Number: 25JDA434; Medline Kit Number/SKU DYNJ0101292J: UDI/DI each 10198459299926, UDI/DI case 40198459299927, Lot Number: 25HDA313; Medline Kit Number/SKU DYNJ0101292J: UDI/DI each 10198459299926, UDI/DI case 40198459299927, Lot Number: 25GDB018; Medline Kit Number/SKU DYNJ0101292J: UDI/DI each 10198459299926, UDI/DI case 40198459299927, Lot Number: 25FDA144; Medline Kit Number/SKU DYNJ0101292J: UDI/DI each 10198459299926, UDI/DI case 40198459299927, Lot Number: 25EDA134; Medline Kit Number/SKU DYNJ0101292J: UDI/DI each 10198459299926, UDI/DI case 40198459299927, Lot Number: 25CDB120; Medline Kit Number/SKU DYNJ0117497F: UDI/DI each 10888277755284, UDI/DI case 40888277755285, Lot Number: 21ABN541; Medline Kit Number/SKU DYNJ0117497J: UDI/DI each 10195327587529, UDI/DI case 40195327587520, Lot Number: 24ILB090; Medline Kit Number/SKU DYNJ0117497J: UDI/DI each 10195327587529, UDI/DI case 40195327587520, Lot Number: 24ILA075; Medline Kit Number/SKU DYNJ0117497J: UDI/DI each 10195327587529, UDI/DI case 40195327587520, Lot Number: 24HLA525; Medline Kit Number/SKU DYNJ0117497J: UDI/DI each 10195327587529, UDI/DI case 40195327587520, Lot Number: 24GLA636; Medline Kit Number/SKU DYNJ0117497J: UDI/DI each 10195327587529, UDI/DI case 40195327587520, Lot Number: 24GLA471; Medline Kit Number/SKU DYNJ0117497J: UDI/DI each 10195327587529, UDI/DI case 40195327587520, Lot Number: 24DLA859; Medline Kit Number/SKU DYNJ0117497J: UDI/DI each 10195327587529, UDI/DI case 40195327587520, Lot Number: 24ALA951; Medline Kit Number/SKU DYNJ0117497J: UDI/DI each 10195327587529, UDI/DI case 40195327587520, Lot Number: 24ALA133; Medline Kit Number/SKU DYNJ0117497J: UDI/DI each 10195327587529, UDI/DI case 40195327587520, Lot Number: 24ALA166; Medline Kit Number/SKU DYNJ0117497K: UDI/DI each 10198459285738, UDI/DI case 40198459285739, Lot Number: 26ALA390; Medline Kit Number/SKU DYNJ0117497K: UDI/DI each 10198459285738, UDI/DI case 40198459285739, Lot Number: 25LLA293; Medline Kit Number/SKU DYNJ0117497K: UDI/DI each 10198459285738, UDI/DI case 40198459285739, Lot Number: 25JLB113; Medline Kit Number/SKU DYNJ0117497K: UDI/DI each 10198459285738, UDI/DI case 40198459285739, Lot Number: 25JLA121; Medline Kit Number/SKU DYNJ0117497K: UDI/DI each 10198459285738, UDI/DI case 40198459285739, Lot Number: 25HLB022; Medline Kit Number/SKU DYNJ0117497K: UDI/DI each 10198459285738, UDI/DI case 40198459285739, Lot Number: 25GLA528; Medline Kit Number/SKU DYNJ0117497K: UDI/DI each 10198459285738, UDI/DI case 40198459285739, Lot Number: 25DLB078; Medline Kit Number/SKU DYNJ0117497K: UDI/DI each 10198459285738, UDI/DI case 40198459285739, Lot Number: 25DLA580; Medline Kit Number/SKU DYNJ0151196G: UDI/DI each 10198459521188
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2235-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2237-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2236-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2234-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2232-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.