Class IIDeviceOngoing

Medline Industries, LP

Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; 2) NEURO PACK-LF, Catalog Number: DYNJ41246F; 3) CRANIOTOMY PACK (CRSJE)227-LF, Catalog Number: DYNJ47487A; 4) MAJOR NEURO PACK, Catalog Number: DYNJ57233J; 5) NEURO, Catalog Number: DYNJ82388A; 6) NEURO PACK, Catalog Number: DYNJ86656; 7) NEURO ACD, Catalog Number: DYNJ904549G

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.

Details

Recall number: Z-3268-2026
Event ID: 99739
Recall initiated: Aug 10, 2026
Classified: Sep 24, 2026
Reported: Sep 30, 2026
Quantity: 234 kits
Distribution: US Nationwide.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Northfield, IL, United States
Lot / code info: 1) DYNJ39218I, UDI-DI: 10195327013042(each), 40195327013043(case), Lot Number: 22HMA400; 2) DYNJ41246F, UDI-DI: 10195327112011(each), 40195327112012(case), Lot Number: 23GBS783; 3) DYNJ47487A, UDI-DI: 10889942106240(each), 40889942106241(case), Lot Number: 22HMD080; 4) DYNJ57233J, UDI-DI: 10198459723025(each), 40198459723026(case), Lot Number: 26CMG313; 5) DYNJ82388A, UDI-DI: 10195327482749(each), 40195327482740(case), Lot Number: 25KMB622; 6) DYNJ86656, UDI-DI: 10195327663155(each), 40195327663156(case), Lot Number: 24EDB134; 7) DYNJ904549G, UDI-DI: 10193489832686(each), 40193489832687(case), Lot Number: 23IBL172