American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK - 208400,...
FDA Device Recall #Z-2989-2026 - Class II, May 19, 2026
Recall Summary
| Recall Number | Z-2989-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | May 19, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | American Contract Systems Inc |
| Location | Tiffin, OH |
| Product Type | Devices |
| Quantity | 4789 kits |
Product Description
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.
Distribution Pattern
US distribution to states of: MN, MO, IA
Lot / Code Information
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.
Other Recalls from American Contract Systems Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3003-2026 | Class II | American Contract System Convenience Kit, D & C... | Jun 29, 2026 |
| Z-3000-2026 | Class II | American Contract System Convenience Kit, CV B ... | Jun 29, 2026 |
| Z-3001-2026 | Class II | American Contract System Convenience Kit, CV B ... | Jun 29, 2026 |
| Z-3002-2026 | Class II | American Contract System Convenience Kits, CV B... | Jun 29, 2026 |
| Z-2990-2026 | Class II | American Contract Systems medical procedure kit... | May 19, 2026 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately, you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.