Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,

FDA Device Recall #Z-2033-2026 — Class II — March 19, 2026

Recall Summary

Recall Number Z-2033-2026
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 538201 kits

Product Description

Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,

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 CDS780056K: UDI/DI each 10888277941373, UDI/DI case 40888277941374, Lot Number: 21DBU610; Medline Kit Number/SKU CDS780056L: UDI/DI each 10193489897593, UDI/DI case 40193489897594, Lot Number: 21KBG946; Medline Kit Number/SKU CDS780056L: UDI/DI each 10193489897593, UDI/DI case 40193489897594, Lot Number: 21IBV394; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23IBO480; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23FBL915; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23EBP966; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23DBB223; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23CBO553; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23ABG956; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22KBD840; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22IBK666; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22HBZ276; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22GBK671; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22FBI951; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22EBE862; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22OBA987; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22BBC815; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21KBC808; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21HBM967; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21FBD640; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21DBN004; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21DBB965; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25BBU070; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25BBS617; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25ABT989; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25ABR939; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25ABE858; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24KBU114; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24KBB359; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24KBA010; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24IBP286; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24IBI821; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 26BBJ914; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 26ABU117; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25KBB123; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25JBJ200; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25GBX170; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25GBD249; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25FBV077; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25FBB825; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25BBS499; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25ABF429; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 24LBK961; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 23ABU440; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 23ABM574; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22KBM775; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22IBN540; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22HBH464; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22EBM543; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22DBL468; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22BBQ627; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22ABH903; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 21FBD429; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23HMF568; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23GMD696; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23EMG749; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23EMF336; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23DMG955; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23DMB891; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23BMF118; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 22EMF683; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 22CMB893; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 22AME418; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 22AMB644; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 21HMG159; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 21GMD475; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 21EME444; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 21CKA528; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 24CMH800; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 24AME651; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 25EMC695; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 25DMH430; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 25CMC383; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 25BMA577; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 24LMF931; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 24IMI022; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 24HMD414; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 24GMF641; Medline Kit Number/SKU CDS780230M: UDI/DI each 10198459371530, UDI/DI case 40198459371531, Lot Number: 25LMB182; Medline Kit Number/SKU CDS780230M: UDI/DI each 10198459371530, UDI/DI case 40198459371531, Lot Number: 25JME944; Medline Kit Number/SKU CDS840193AA: UDI/DI each 10198459624650, UDI/DI case 40198459624651, Lot Number: 26BBI688; Medline Kit Number/SKU CDS981327Q: UDI/DI each 10195327080365, UDI/DI case 40195327080366, Lot Number: 22IMA515; Medline Kit Number/SKU CDS981327Q: UDI/DI each 10195327080365, UDI/DI case 40195327080366, Lot Number: 22GMH480; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 25DMA275; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 25CMC073; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 25BMH093; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 25AMJ526; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24KMC461; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24JMG627; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24IMA421; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24FMJ886; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24FMI364; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24FMC468; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24EMJ857; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24DME653; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24DME236; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 23LMH592; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 26BMD798; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 26AMJ740; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 26AMK056; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 25KME621; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 25HMI011; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 25GMD593; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 25EMJ777; Medline Kit Number/SKU CDS982598J: UDI/DI each 10193489814835, UDI/DI case 40193489814836, Lot Number: 21KMB552; Medline Kit Number/SKU CDS982598J: UDI/DI each 10193489814835, UDI/DI case 40193489814836, Lot Number: 21JMA057; Medline Kit Number/SKU CDS982598J: UDI/DI each 10193489814835, UDI/DI case 40193489814836, Lot Number: 21IMG287; Medline Kit Number/SKU CDS982598J: UDI/DI each 10193489814835, UDI/DI case 40193489814836, Lot Number: 21HMH155; Medline Kit Number/SKU CDS982598J: UDI/DI each 10193489814835, UDI/DI case 40193489814836, Lot Number: 21GMD446; Medline Kit Number/SKU CDS982598J: UDI/DI each 10193489814835, UDI/DI case 40193489814836, Lot Number: 21CKA360; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 23BBE227; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 22LBR320; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 22JBD908; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 22HBC474; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 22FBR329; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 22EBD183; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 22DBL896; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 22BBQ901; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 21KBZ661; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 21KBD925; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 21HBB507; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 21FBC705; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 21DBF391; Medline Kit Number/SKU CDS983067O: UDI/DI each 10193489923919, UDI/DI case 40193489923910, Lot Number: 21GBW329; Medline Kit Number/SKU CDS983067O: UDI/DI each 10193489923919, UDI/DI case 40193489923910, Lot Number: 21GBW330; Medline Kit Number/SKU CDS983067P: UDI/DI each 10193489992410, UDI/DI case 40193489992411, Lot Number: 21JBI914; Medline Kit Number/SKU CDS983067Q: UDI/DI each 10195327014414, UDI/DI case 40195327014415, Lot Number: 21VBA261; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22KBR625; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22JBA128; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22IBG254; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22HBE402; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22HBB675; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22GBT165; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22FBL412; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22OBI098; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22OBF807; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22OBA439; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22BBN430; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22ABR754; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 23EBN868; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 23DBO557; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 23DBA498; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 23CBO871; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 23ABD958; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 23ABE748; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 22LBC196; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 22EBV250; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 22EBU143; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 22CBM750; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 25FBF374; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 25FBD169; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 25ABQ324; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 25ABF107; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24KBG200; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24JBA335; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24HBG928; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24GBY600; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24FBS184; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24EBV541; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24EBA092; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24DBJ888; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24CBT420; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24BBN502; Medline Kit Number/SKU CDS983186K: UDI/DI each 10198459413407, UDI/DI case 40198459413408, Lot Number: 26BBU064; Medline Kit Number/SKU CDS983186K: UDI/DI each 10198459413407, UDI/DI case 40198459413408, Lot Number: 26BBE547; Medline Kit Number/SKU CDS983186K: UDI/DI each 10198459413407, UDI/DI case 40198459413408, Lot Number: 25JBJ027; Medline Kit Number/SKU CDS983186K: UDI/DI each 10198459413407, UDI/DI case 40198459413408, Lot Number: 25IBE728; Medline Kit Number/SKU CDS983186K: UDI/DI each 10198459413407, UDI/DI case 40198459413408, Lot Number: 25HBC629; Medline Kit Number/SKU CDS983383G: UDI/DI each 10193489820379, UDI/DI case 40193489820370, Lot Number: 21IBD823; Medline Kit Number/SKU CDS983383G: UDI/DI each 10193489820379, UDI/DI case 40193489820370, Lot Number: 21FBA066; Medline Kit Number/SKU CDS983383G: UDI/DI each 10193489820379, UDI/DI case 40193489820370, Lot Number: 21DBT982; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 22JBH486; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 22HBJ838; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 22GBW341; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 22EBQ443; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 22EBR513; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 22CBJ547; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 22BBQ628; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 21JBQ856; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 21JBD152; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 21IBS277; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 23IBU124; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 23HBJ253; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 23FBL780; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 23DBE062; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 23BBG735; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 22LBG966; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 22KBK505; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 24BBK578; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 24BBE238; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 23LBP200; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 23KBW057; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 25ABF837; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 24LBF687; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 24JBX543; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 24JBN204; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 24IBI682; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 24HBE586; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 24GBH753; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 24FBF076; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 24DBS374; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 24CBG287; Medline Kit Number/SKU CDS983383L: UDI/DI each 10198459224577, UDI/DI case 40198459224578, Lot Number: 26BBA010; Medline Kit Number/SKU CDS983383L: UDI/DI each 10198459224577, UDI/DI case 40198459224578, Lot Number: 25LBC092; Medline Kit Number/SKU CDS983383L: UDI/DI each 10198459224577, UDI/DI case 40198459224578, Lot Number: 25JBO557; Medline Kit Number/SKU CDS983383L: UDI/DI each 10198459224577, UDI/DI case 40198459224578, Lot Number: 25IBA300; Medline Kit Number/SKU CDS983383L: UDI/DI each 10198459224577, UDI/DI case 40198459224578, Lot Number: 25GBM558; Medline Kit Number/SKU CDS983383L: UDI/DI each 10198459224577, UDI/DI case 40198459224578, Lot Number: 25FBQ369; Medline Kit Number/SKU CDS983383L: UDI/DI each 10198459224577, UDI/DI case 40198459224578, Lot Number: 25FBH080; Medline Kit Number/SKU CDS983383L: UDI/DI each 10198459224577, UDI/DI case 40198459224578, Lot Number: 25DBR706; Medline Kit Number/SKU CDS983383L: UDI/DI each 10198459224577, UDI/DI case 40198459224578, Lot Number: 25BBS434; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 23EBE364; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 23CBU024; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 23CBN738; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 22KBS879; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 22KBU352; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 22IBS408; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 22EBF941; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 22DBC999; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 21KBW920; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 21DBO237; Medline Kit Number/SKU CDS983882I: UDI/DI each 10198459429774, UDI/DI case 40198459429775, Lot Number: 26BBI689; Medline Kit Number/SKU CDS983882I: UDI/DI each 10198459429774, UDI/DI case 40198459429775, Lot Number: 26ABJ517; Medline Kit Number/SKU CDS983882I: UDI/DI each 10198459429774, UDI/DI case 40198459429775, Lot Number: 25IBS521; Medline Kit Number/SKU CDS983882I: UDI/DI each 10198459429774, UDI/DI case 40198459429775, Lot Number: 25HBR957; Medline Kit Number/SKU CDS983882I: UDI/DI each 10198459429774, UDI/DI case 40198459429775, Lot Number: 25HBF943; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 23FBL260; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 23EBU951; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 23EBK997; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 23CBI556; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 23ABL469; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 23ABN789; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 22KBS655; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 22JBJ163; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 22FBX184; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 22FBH437; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 22EBF942; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 22DBB159; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 22CLA523; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 21JBX843; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 21JBS156; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 21IBU462; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 21HBQ028; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 21FBE881; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 21FBE882; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 21CBT329; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 25CBJ495; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 25BBI017; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 25ABD227; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 24KBQ712; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 24JBK509; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 24JBH672; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 24HBO308; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 24GBH754; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 24DBB586; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 24CBJ688; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 24ABB735; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 23KBU576; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 23KBU834; Medline Kit Number/SKU CDS983885I: UDI/DI each 10198459429729, UDI/DI case 40198459429720, Lot Number: 25JBX514; Medline Kit Number/SKU CDS983885I: UDI/DI each 10198459429729, UDI/DI case 40198459429720, Lot Number: 25IBU968; Medline Kit Number/SKU CDS983885I: UDI/DI each 10198459429729, UDI/DI case 40198459429720, Lot Number: 25HBF944; Medline Kit Number/SKU CDS983981J: UDI/DI each 10193489312065, UDI/DI case 40193489312066, Lot Number: 22ABZ200; Medline Kit Number/SKU CDS983981J: UDI/DI each 10193489312065, UDI/DI case 40193489312066, Lot Number: 21KBA430; Medline Kit Number/SKU CDS983981J: UDI/DI each 10193489312065, UDI/DI case 40193489312066, Lot Number: 21GBE942; Medline Kit Number/SKU CDS983981J: UDI/DI each 10193489312065, UDI/DI case 40193489312066, Lot Number: 21DBE159; Medline Kit Number/SKU CDS983981J: UDI/DI each 10193489312065, UDI/DI case 40193489312066, Lot Number: 21BBF817; Medline Kit Number/SKU CDS983981K: UDI/DI each 10195327086923, UDI/DI case 40195327086924, Lot Number: 23ABG042; Medline Kit Number/SKU CDS983981K: UDI/DI each 10195327086923, UDI/DI case 40195327086924, Lot Number: 22HBM662; Medline Kit Number/SKU CDS983981K: UDI/DI each 10195327086923, UDI/DI case 40195327086924, Lot Number: 22HBM664; Medline Kit Number/SKU CDS983981K: UDI/DI each 10195327086923, UDI/DI case 40195327086924, Lot Number: 22EBI118; Medline Kit Number/SKU CDS983981K: UDI/DI each 10195327086923, UDI/DI case 40195327086924, Lot Number: 22EBG587; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 23KBN899; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 23KBN714; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 23IBU172; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 23IBT871; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 23GBT893; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 23GBK552; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 23FBN470; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 24IBR079; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 24IBD748; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 24HBO845; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 24HBE588; Medline Kit Number/SKU CDS983981L: UDI/DI each 101953

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.