FDA Device recall Z-2997-2026
Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548
- FDA Device
- Class II
- ongoing
- Published 2026-09-02
On 2026-09-02 the FDA classified a Class II recall of Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548 by Medline Industries, citing 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 le….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2997-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-08 |
| Published | 2026-09-02 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ44504G; 3) NEURO SPINE PACK, Medline Kit SKU DYNJ45419F; 4) CRANIOTOMY PACK, Medline Kit SKU DYNJ46024F; 5) SPINE PACK, Medline Kit SKU DYNJ54479C; 6) CRANIOTOMY PACK, Medline Kit SKU DYNJ58006B; 7) ORTHO-LAMINECTOMY PACK, Medline Kit SKU DYNJ58014A; 8) SPINE PACK, Medline Kit SKU DYNJ83585; 9) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056; 10) CRANI MT CARMEL, Medline Kit SKU DYNJ900467I; 11) GP-NEURO SPINE PACK-LF, Medline Kit SKU PHS396933009C.
Reason
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.
Identifiers
| code_info | Medline Kit SKU DYNJT6548, UDI/DI 10198459558764 (each) 40198459558765 (case), Lot Number 25JMF561; Medline Kit SKU DY…Medline Kit SKU DYNJT6548, UDI/DI 10198459558764 (each) 40198459558765 (case), Lot Number 25JMF561; Medline Kit SKU DYNJ44504G, UDI/DI 10198459241956 (each) 40198459241957 (case), Lot Number 25EDA305; Medline Kit SKU DYNJ44504G, UDI/DI 10198459241956 (each) 40198459241957 (case), Lot Number 25EDB254; Medline Kit SKU DYNJ45419F, UDI/DI 10195327625689 (each) 40195327625680 (case), Lot Number 24JMF418; Medline Kit SKU DYNJ45419F, UDI/DI 10195327625689 (each) 40195327625680 (case), Lot Number 24JMJ129; Medline Kit SKU DYNJ46024F, UDI/DI 10195327237011 (each) 40195327237012 (case), Lot Number 23HBJ773; Medline Kit SKU DYNJ54479C, UDI/DI 10193489460254 (each) 40193489460255 (case), Lot Number 23HBA720; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 23BMC930; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot Number 23FMD505; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case), Lot |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2997-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.