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CLASS II · ModerateFDA

American Contract Systems Inc recalls American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK

📅 May 19, 2026 · 📍 IA, MN, MO
Recalling company
American Contract Systems Inc
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
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
May 19, 2026
Reported
Aug 26, 2026
Distribution
US distribution to states of: MN, MO, IA
Status
Ongoing
Quantity
4789 kits
Lot / codes
Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8388111; Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8474311; Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8521711; Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8547611; Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8672411; Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8775211; Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8810511; Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8447111; Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8548311; Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8630311; Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8785011; Model/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8742911; Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8455911; Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8498111; Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8538111; Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8601211; Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8764511; Model/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8823811; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8384311; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8525011; Model/Item Number ANCI17AO, UDI/DI 19107
Company location
Tiffin, OH
Recall type
Voluntary: Firm initiated
Recall number
Z-2989-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2989-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.