Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; ...
FDA Device Recall #Z-2994-2026 - Class II, July 8, 2026
Recall Summary
| Recall Number | Z-2994-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | July 8, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 2262 kits |
Product Description
Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK, Medline Kit SKU DYNJ44480D; 5) ENT NASAL ORAL PACK MOSES, Medline Kit SKU DYNJ58928A; 6) HEAD & NECK PACK, Medline Kit SKU DYNJ83296; 7) TRANSPHENOIDAL PACK, Medline Kit SKU DYNJ89006; 8) SINUS, Medline Kit SKU DYNJ900537D; 9) SINUS, Medline Kit SKU DYNJ900537F; 10) ENT HEAD & NECK, Medline Kit SKU DYNJ903679F; 11) ENT HEAD & NECK, Medline Kit SKU DYNJ903679G; 12) ENT HEAD & NECK, Medline Kit SKU DYNJ903679I; 13) ENT HEAD & NECK, Medline Kit SKU DYNJ903679J; 14) ENT HEAD & NECK, Medline Kit SKU DYNJ903679K.
Reason for Recall
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.
Lot / Code Information
Medline Kit SKU DYNJ0966146F, UDI/DI 10193489916379 (each) 40193489916370 (case), Lot Number 23HBC070; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 24CBA416; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23CBS214; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23FBC803; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23GBU042; Medline Kit SKU DYNJ40154D, UDI/DI 10889942968732 (each) 40889942968733 (case), Lot Number 23IBO417; Medline Kit SKU DYNJ40154F, UDI/DI 10195327679293 (each) 40195327679294 (case), Lot Number 24EBH594; Medline Kit SKU DYNJ40154F, UDI/DI 10195327679293 (each) 40195327679294 (case), Lot Number 24FBQ494; Medline Kit SKU DYNJ40154F, UDI/DI 10195327679293 (each) 40195327679294 (case), Lot Number 24JBK316; Medline Kit SKU DYNJ44480D, UDI/DI 10198459241727 (each) 40198459241728 (case), Lot Number 25CDA135; Medline Kit SKU DYNJ58928A, UDI/DI 10193489763973 (each) 40193489763974 (case), Lot Number 23HBK833; Medline Kit SKU DYNJ83296, UDI/DI 10195327258917 (each) 40195327258918 (case), Lot Number 24FBQ476; Medline Kit SKU DYNJ83296, UDI/DI 10195327258917 (each) 40195327258918 (case), Lot Number 23EBI941; Medline Kit SKU DYNJ83296, UDI/DI 10195327258917 (each) 40195327258918 (case), Lot Number 23HBX888; Medline Kit SKU DYNJ83296, UDI/DI 10195327258917 (each) 40195327258918 (case), Lot Number 22KBR883; Medline Kit SKU DYNJ89006, UDI/DI 10198459241970 (each) 40198459241971 (case), Lot Number 25JMC017; Medline Kit SKU DYNJ89006, UDI/DI 10198459241970 (each) 40198459241971 (case), Lot Number 25KMB183; Medline Kit SKU DYNJ89006, UDI/DI 10198459241970 (each) 40198459241971 (case), Lot Number 25AMG343; Medline Kit SKU DYNJ89006, UDI/DI 10198459241970 (each) 40198459241971 (case), Lot Number 25DMJ252; Medline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 23ABM594; Medline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 23DBQ757; Medline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 23EBL559; Medline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 22FBC585; Medline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 22GBO880; Medline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 22HBN179; Medline Kit SKU DYNJ900537D, UDI/DI 10888277775206 (each) 40888277775207 (case), Lot Number 22HBU967; Medline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 25CME312; Medline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 25FME826; Medline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 24IMA157; Medline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 24IMF249; Medline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 23EBI617; Medline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 23GBJ097; Medline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 23HBS862; Medline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 23JBU735; Medline Kit SKU DYNJ900537F, UDI/DI 10195327397371 (each) 40195327397372 (case), Lot Number 23KBI060; Medline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 23ABS340; Medline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 23ABS768; Medline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 23BBB045; Medline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 23HBP969; Medline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 22HBR343; Medline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 22HBT245; Medline Kit SKU DYNJ903679F, UDI/DI 10195327182908 (each) 40195327182909 (case), Lot Number 22LBL269; Medline Kit SKU DYNJ903679G, UDI/DI 10195327488093 (each) 40195327488094 (case), Lot Number 24DBD707; Medline Kit SKU DYNJ903679G, UDI/DI 10195327488093 (each) 40195327488094 (case), Lot Number 24DBD912; Medline Kit SKU DYNJ903679G, UDI/DI 10195327488093 (each) 40195327488094 (case), Lot Number 24HBR037; Medline Kit SKU DYNJ903679G, UDI/DI 10195327488093 (each) 40195327488094 (case), Lot Number 24IBF556; Medline Kit SKU DYNJ903679G, UDI/DI 10195327488093 (each) 40195327488094 (case), Lot Number 24JBM973; Medline Kit SKU DYNJ903679G, UDI/DI 10195327488093 (each) 40195327488094 (case), Lot Number 23LBG405; Medline Kit SKU DYNJ903679I, UDI/DI 10198459225758 (each) 40198459225759 (case), Lot Number 25BBD293; Medline Kit SKU DYNJ903679I, UDI/DI 10198459225758 (each) 40198459225759 (case), Lot Number 25BBF473; Medline Kit SKU DYNJ903679I, UDI/DI 10198459225758 (each) 40198459225759 (case), Lot Number 25BBF871; Medline Kit SKU DYNJ903679J, UDI/DI 10198459313035 (each) 40198459313036 (case), Lot Number 25DBU804; Medline Kit SKU DYNJ903679J, UDI/DI 10198459313035 (each) 40198459313036 (case), Lot Number 25EBN687; Medline Kit SKU DYNJ903679J, UDI/DI 10198459313035 (each) 40198459313036 (case), Lot Number 25FBR466; Medline Kit SKU DYNJ903679K, UDI/DI 10198459399916 (each) 40198459399917 (case), Lot Number 25HBF447; Medline Kit SKU DYNJ903679K, UDI/DI 10198459399916 (each) 40198459399917 (case), Lot Number 25KBT345.
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2993-2026 | Class II | Medline breathing circuits labeled as: 1) ME... | Jul 13, 2026 |
| Z-2991-2026 | Class II | Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATOR... | Jul 13, 2026 |
| Z-2992-2026 | Class II | Medline breathing circuits labeled as: 1) HU... | Jul 13, 2026 |
| Z-3027-2026 | Class II | Medline convenience kits labeled as: 1) LAVH... | Jul 10, 2026 |
| Z-3021-2026 | Class II | Medline convenience kits labeled as: MAJOR HEA... | Jul 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.