FDAClass IIAugust 26, 2026

American Contract Systems medical procedure kits and recall: Endotoxin

American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item…

Why was American Contract Systems medical procedure kits and recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400, Model Item Number UDCP57AI; 2) SPINE PACK, Model Item…
Recalling firm
American Contract Systems Inc
Quantity
4789 kits
Distribution
US distribution to states of: MN, MO, IA
Recall date
August 26, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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