FDA recall, , Moderate risk
American Contract Systems Medical Procedure Kits and Trays
Medical procedure kits and trays may have unexpected variability of endotoxin levels on included sponges.
Summary by Recall Canary from the FDA notice
What happened
American Contract Systems Inc of Tiffin, Ohio, began a recall on May 19, 2026, of medical procedure kits and trays due to a Medicom Urgent Medical Device Recall of specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C, which may have unexpected variability of endotoxin levels. The FDA added the recall to its Enforcement Report on August 20, 2026, and it was in the weekly enforcement report on August 26, 2026, affecting Iowa, Minnesota, and Missouri.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Match the list below, then check the codes the FDA notice also names.
A UDI-DI is the device identifier printed with the barcode on the device label.
American Contract Systems medical procedure kits and trays
- UDI-DI
- 191072211910
- 191072214782
- Lot code
- 42-8606211
- 42-8687611
- 42-8847511
- 42-8423411
- 42-8470411
- 42-8527611
- 42-8601311
- 42-8731511
- 42-8795311
- UDI-DI
- 191072216250
- 191072238207
- 191072211934
- 191072232052
- 191072232069
- 191072214287
- 191072214423
- 191072232045
- 191072232076
- Lot code
- 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
- 42-8345311
- 42-8379411
- 42-8547011
- 42-8654511
- 42-8746311
- 42-8801611
- 42-8401611
- 42-8611411
- 42-8611411A
- 42-8648311
- 42-8755811
- 42-8807911
- 42-8852311
- 42-8869511
- 42-8384511
- 42-8545711
- 42-8634611
- 42-8707111
- 42-8789211
- 42-8831811
- 42-8853011
- 42-8868811
Recall details
- Company began the recall
- Company
- American Contract Systems IncTiffin, Ohio
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99482
- Recall numbers
- Z-2989-2026 to Z-2990-2026
All recalls from American Contract Systems Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
