American Contract Systems Procedure Kits
American Contract Systems recalls 9 procedure kits due to potential endotoxin variability in included neurological sponges.
Do not use the affected procedure kits or trays. Quarantine them and contact American Contract Systems for instructions on returning the products and obtaining a replacement.
Why it was recalled
American Contract Systems is recalling nine medical procedure kits and trays because they contain Medicom Ritmed Neurological Sponges (Models 55992C to 55998C) that may have unexpected variability in endotoxin levels, posing a risk of adverse reactions in patients.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
American Contract Systems medical procedure kits and trays labeled
| Product | Lot code | Recall # | UDI-DI |
|---|---|---|---|
| as | 42-8606211, 42-8687611, 42-8847511, 42-8423411, 42-8470411, 42-8527611, 42-8601311, 42-8731511, 42-8795311 | Z-2990-2026 | 191072211910, 191072211910, 191072211910, 191072214782, 191072214782, 191072214782, 191072214782, 191072214782, 191072214782 |
| as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item Number HSLM53AC; 3) CRANIAL PACK - 205992, Model Item Number MHCP75AH; 4) IMRI CRANI PACK - 213871, Model Item Number ANCI17AO; 5) CRANI PACK - 205942, Model Item Number ANCP30AP; 6) A-P PACK - 205936, Model Item Number ANAP22AP; 7) POSTERIOR PACK - 205960, Model Item Number ANPP15AR; 8) ANTERIOR CERVICAL PACK - 205935, Model Item N | – | Z-2989-2026 | 191072216250, 191072216250, 191072216250, 191072216250, 191072216250, 191072216250, 191072216250, 191072238207, 191072238207, 191072238207, 191072238207, 191072238207, 191072211934, 191072211934, 191072211934, 191072211934, 191072211934, 191072211934, 191072232052, 191072232052 |
| as | 42-8388111, 42-8474311, 42-8521711, 42-8547611, 42-8672411, 42-8775211, 42-8810511, 42-8447111, 42-8548311, 42-8630311, 42-8785011, 42-8742911, 42-8455911, 42-8498111, 42-8538111, 42-8601211, 42-8764511, 42-8823811, 42-8384311, 42-8525011, 42-8611711, 42-8705911, 42-8798411, 42-8831911, 42-8854511, 42-8497911, 42-8537311, 42-8673211, 42-8756411, 42-8818611, 42-8854011, 42-8869111, 42-8497811, 42-8588811, 42-8666611, 42-8730411, 42-8785411, 42-8833011, 42-8854611, 42-8869611 (+22 more, see the official notice) | – | 191072216250, 191072238207, 191072211934, 191072232052, 191072232069, 191072214287, 191072214423, 191072232045, 191072232076 |
Where it was sold
Distributed in Iowa, Minnesota, and Missouri.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Sterility Failure recalls
Other recent recalls from American Contract Systems Inc
Editorial summary by Recall Canary · summary updated 2026-08-21 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification