American Contract Systems medical procedure kits and trays labeled… — Class II medical device recall Z-2989-2026
Ongoing recall by American Contract Systems Inc, reported 2026-08-26, distributed in IA, MN, MO. The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific l
| Recall number | Z-2989-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Contract Systems Inc, Tiffin, OH, United States |
| Recall initiated | 2026-05-19 |
| Classified | 2026-08-20 |
| Reported by FDA | 2026-08-26 |
| Distributed | IA, MN, MO |
| Quantity | 4,789 kits |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00191072211934, 00191072214287, 00191072214423, 00191072216250, 00191072232045, 00191072232052, 00191072232069, 00191072232076, 00191072238207 |
| Lot numbers | 42-8345311, 42-8379411, 42-8384311, 42-8384511, 42-8388111, 42-8401611, 42-8447111, 42-8455911, 42-8474311, 42-8497811, 42-8497911, 42-8498111, 42-8521711, 42-8525011, 42-8537311, 42-8538111, 42-8545711, 42-8547011, 42-8547611, 42-8548311, 42-8588811, 42-8601211, 42-8611411, 42-8611411A, 42-8611711, 42-8630311, 42-8634611, 42-8648311, 42-8654511, 42-8666611, 42-8672411, 42-8673211, 42-8705911, 42-8707111, 42-8730411, 42-8742911, 42-8746311, 42-8755811, 42-8756411, 42-8764511 and 22 more |
| Model numbers | ANAN51AI, ANAP22AP, ANCI17AO, ANCP30AP, ANLM40AG, ANPP15AR, HSLM53AC, MHCP75AH, UDCP57AI |
Product
American Contract Systems medical procedure kits and trays labeled 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 Number ANAN51AI; 9) LAMINECTOMY PACK - 205957, Model Item Number ANLM40AG.
Reason for recall
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2989-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.