Z-3265-2026 Class II Ongoing
FDA device recall Z-3265-2026 was initiated by Medline Industries, LP on Aug 10, 2026 and is designated Class II. Reason for recall: The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical inter… The recall status is ongoing. Affected quantity: 695 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 30, 2026
- Initiation Date
- Aug 10, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 695 kits
Product Description
Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ0342705J; 3) NASAL-LF, Catalog Number: DYNJ40094G; 4) ENT PACK, Catalog Number: DYNJ50699F; 5) EENT PACK, Catalog Number: DYNJ83219
Reason for Recall
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
Distribution Pattern
US Nationwide.
Code Information
1) DYNJ02516G, UDI-DI: 10889942295234(each), 40889942295235(case), Lot Number: 22HME611; 2) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 23GMI728; 3) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 23EME909; 4) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 23CMG752; 5) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 23CMB449; 6) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 23AMI951; 7) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 22KMD941; 8) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 22JMC071; 9) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 22FMD388; 10) DYNJ40094G, UDI-DI: 10195327170813(each), 40195327170814(case), Lot Number: 23HMA901; 11) DYNJ50699F, UDI-DI: 10193489826555(each), 40193489826556(case), Lot Number: 23HMA420; 12) DYNJ83219, UDI-DI: 10195327247720(each), 40195327247721(case), Lot Number: 23GBH079; 13) DYNJ83219, UDI-DI: 10195327247720(each), 40195327247721(case), Lot Number: 23FBB663; 14) DYNJ83219, UDI-DI: 10195327247720(each), 40195327247721(case), Lot Number: 23DBS195; 15) DYNJ83219, UDI-DI: 10195327247720(each), 40195327247721(case), Lot Number: 22LBG199