Recall Z-2459-2026
- Recall number
- Z-2459-2026
- Event number
- 99006
- Firm
- AMD Medicom Inc. 2555 Ch de L'Aviation Montreal Canada
- Firm FEI
- 3002677549
- Product code
- EFQ
- Status
- Open, Classified
- Initiated
- 2026-05-08
- Posted
- 2026-06-16
- Root cause
- Material/Component Contamination
- 510(k) numbers
- K830269, K802010, K861154, K963134, K820106, K882529, K935931, K792615, K940716, K802861, K982648, K792612, K861308, K792431, K832174, K882021, K863761, K953501, K961775, K802383, K912955, K963188, K923041, K951660, K802022, K803172, K955165, K940904, K936095, K802387
Product#
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
Reason for Recall#
Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.