Device recall
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
- Recall number
- Z-3268-2026
- Event id
- 99739
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Medline Industries, LP
- Report date
- Sep 30, 2026
- Posted
- Sep 24, 2026
- Initiated
- Aug 10, 2026
- Center classification date
- Sep 24, 2026
- Product code
- OJG
- Device type
- Neurological Tray
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Quantity
- 234 kits
- 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
- Distribution
- US Nationwide.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Northfield, IL, United States