FDA Device Recalls

Class IIOngoing

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.

Medline Industries, LP

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.

July 8, 2026 · DeviceView details →

Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S

Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L; 3) GYN LAP HYSTERECTOMY CDS, Medline Kit SKU CDS982662Q; 4) CMH VAG HYSTERECTOMY PK-LF, Medline Kit SKU DYNJ54382F; 5) A P RESECTION, Medline Kit SKU DYNJ903467L.

Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03

Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27

Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03

Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03

Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter

Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03

Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03

Generic Name: Kit, Urine, Clean Catch Trade Name: Kit: Urinary Clean Catch 20/cs Model/Catalog Number: 76769 Lot Number: 333606 UDI-DI: 20809160118228 Software Version: N/A

Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter

Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03

TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798

Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4) THYROID ENT, Medline Kit SKU DYNJ908641.

Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131