FDAFDA recall Z-2989-2026 · Aug 26, 2026

American Contract Systems Inc: American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208 recall

Recall found

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.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status: Ongoing
Codes, lots and dates: 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 191072232052, Lot Number 42-8611711; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8705911; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8798411; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8831911; Model/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8854511; Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8497911; Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8537311; Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8673211; Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8756411; Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8818611; Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8854011; Model/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8869111; Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8497811; Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8588811; Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8666611; Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8730411; Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8785411; Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8833011; Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8854611; Model/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8869611; Model/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8345311; Model/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8379411; Model/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8547011; Model/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8654511; Model/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8746311; Model/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8801611; Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8401611; Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8611411; Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8611411A; Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8648311; Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8755811; Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8807911; Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8852311; Model/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8869511; Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8384511; Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8545711; Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8634611; Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8707111; Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8789211; Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8831811; Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8853011; Model/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8868811.
Quantity: 4789 kits
Distribution: US distribution to states of: MN, MO, IA
Recalling firm: American Contract Systems Inc, Tiffin, OH
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-05-19

Source: openFDA enforcement record Z-2989-2026 · search recall number Z-2989-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.