American Contract Systems Inc recalls American Contract Systems medical procedure kits and trays labeled as: 1) CRANI PACK…
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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.
Lot / code information
- Part / Item #
- UDCP57AI, UDI/DI 191072216250
- Lot #
- 42-8388111; Model/
- Part / Item #
- UDCP57AI, UDI/DI 191072216250
- Lot #
- 42-8474311; Model/
- Part / Item #
- UDCP57AI, UDI/DI 191072216250
- Lot #
- 42-8521711; Model/
- Part / Item #
- UDCP57AI, UDI/DI 191072216250
- Lot #
- 42-8547611; Model/
- Part / Item #
- UDCP57AI, UDI/DI 191072216250
- Lot #
- 42-8672411; Model/
- Part / Item #
- UDCP57AI, UDI/DI 191072216250
- Lot #
- 42-8775211; Model/
- Part / Item #
- UDCP57AI, UDI/DI 191072216250
- Lot #
- 42-8810511; Model/
- Part / Item #
- HSLM53AC, UDI/DI 191072238207
- Lot #
- 42-8447111; Model/
- Part / Item #
- HSLM53AC, UDI/DI 191072238207
- Lot #
- 42-8548311; Model/
- Part / Item #
- HSLM53AC, UDI/DI 191072238207
- Lot #
- 42-8630311; Model/
- Part / Item #
- HSLM53AC, UDI/DI 191072238207
- Lot #
- 42-8785011; Model/
- Part / Item #
- HSLM53AC, UDI/DI 191072238207
- Lot #
- 42-8742911; Model/
- Part / Item #
- MHCP75AH, UDI/DI 191072211934
- Lot #
- 42-8455911; Model/
- Part / Item #
- MHCP75AH, UDI/DI 191072211934
- Lot #
- 42-8498111; Model/
- Part / Item #
- MHCP75AH, UDI/DI 191072211934
- Lot #
- 42-8538111; Model/
- Part / Item #
- MHCP75AH, UDI/DI 191072211934
- Lot #
- 42-8601211; Model/
- Part / Item #
- MHCP75AH, UDI/DI 191072211934
- Lot #
- 42-8764511; Model/
- Part / Item #
- MHCP75AH, UDI/DI 191072211934
- Lot #
- 42-8823811; Model/
- Part / Item #
- ANCI17AO, UDI/DI 191072232052
- Lot #
- 42-8384311; Model/
- Part / Item #
- ANCI17AO, UDI/DI 191072232052
- Lot #
- 42-8525011; Model/
- Part / Item #
- ANCI17AO, UDI/DI 191072232052
- Lot #
- 42-8611711; Model/
- Part / Item #
- ANCI17AO, UDI/DI 191072232052
- Lot #
- 42-8705911; Model/
- Part / Item #
- ANCI17AO, UDI/DI 191072232052
- Lot #
- 42-8798411; Model/
- Part / Item #
- ANCI17AO, UDI/DI 191072232052
- Lot #
- 42-8831911; Model/
- Part / Item #
- ANCI17AO, UDI/DI 191072232052
- Lot #
- 42-8854511; Model/
- Part / Item #
- ANCP30AP, UDI/DI 191072232069
- Lot #
- 42-8497911; Model/
- Part / Item #
- ANCP30AP, UDI/DI 191072232069
- Lot #
- 42-8537311; Model/
- Part / Item #
- ANCP30AP, UDI/DI 191072232069
- Lot #
- 42-8673211; Model/
- Part / Item #
- ANCP30AP, UDI/DI 191072232069
- Lot #
- 42-8756411; Model/
- Part / Item #
- ANCP30AP, UDI/DI 191072232069
- Lot #
- 42-8818611; Model/
- Part / Item #
- ANCP30AP, UDI/DI 191072232069
- Lot #
- 42-8854011; Model/
- Part / Item #
- ANCP30AP, UDI/DI 191072232069
- Lot #
- 42-8869111; Model/
- Part / Item #
- ANAP22AP, UDI/DI 191072214287
- Lot #
- 42-8497811; Model/
- Part / Item #
- ANAP22AP, UDI/DI 191072214287
- Lot #
- 42-8588811; Model/
- Part / Item #
- ANAP22AP, UDI/DI 191072214287
- Lot #
- 42-8666611; Model/
- Part / Item #
- ANAP22AP, UDI/DI 191072214287
- Lot #
- 42-8730411; Model/
- Part / Item #
- ANAP22AP, UDI/DI 191072214287
- Lot #
- 42-8785411; Model/
- Part / Item #
- ANAP22AP, UDI/DI 191072214287
- Lot #
- 42-8833011; Model/
- Part / Item #
- ANAP22AP, UDI/DI 191072214287
- Lot #
- 42-8854611; Model/
- Part / Item #
- ANAP22AP, UDI/DI 191072214287
- Lot #
- 42-8869611; Model/
- Part / Item #
- ANPP15AR, UDI/DI 191072214423
- Lot #
- 42-8345311; Model/
- Part / Item #
- ANPP15AR, UDI/DI 191072214423
- Lot #
- 42-8379411; Model/
- Part / Item #
- ANPP15AR, UDI/DI 191072214423
- Lot #
- 42-8547011; Model/
- Part / Item #
- ANPP15AR, UDI/DI 191072214423
- Lot #
- 42-8654511; Model/
- Part / Item #
- ANPP15AR, UDI/DI 191072214423
- Lot #
- 42-8746311; Model/
- Part / Item #
- ANPP15AR, UDI/DI 191072214423
- Lot #
- 42-8801611; Model/
- Part / Item #
- ANAN51AI, UDI/DI 191072232045
- Lot #
- 42-8401611; Model/
- Part / Item #
- ANAN51AI, UDI/DI 191072232045
- Lot #
- 42-8611411; Model/
- Part / Item #
- ANAN51AI, UDI/DI 191072232045
- Lot #
- 42-8611411A; Model/
- Part / Item #
- ANAN51AI, UDI/DI 191072232045
- Lot #
- 42-8648311; Model/
- Part / Item #
- ANAN51AI, UDI/DI 191072232045
- Lot #
- 42-8755811; Model/
- Part / Item #
- ANAN51AI, UDI/DI 191072232045
- Lot #
- 42-8807911; Model/
- Part / Item #
- ANAN51AI, UDI/DI 191072232045
- Lot #
- 42-8852311; Model/
- Part / Item #
- ANAN51AI, UDI/DI 191072232045
- Lot #
- 42-8869511; Model/
- Part / Item #
- ANLM40AG, UDI/DI 191072232076
- Lot #
- 42-8384511; Model/
- Part / Item #
- ANLM40AG, UDI/DI 191072232076
- Lot #
- 42-8545711; Model/
- Part / Item #
- ANLM40AG, UDI/DI 191072232076
- Lot #
- 42-8634611; Model/
- Part / Item #
- ANLM40AG, UDI/DI 191072232076
- Lot #
- 42-8707111; Model/
- Part / Item #
- ANLM40AG, UDI/DI 191072232076
- Lot #
- 42-8789211; Model/
- Part / Item #
- ANLM40AG, UDI/DI 191072232076
- Lot #
- 42-8831811; Model/
- Part / Item #
- ANLM40AG, UDI/DI 191072232076
- Lot #
- 42-8853011; Model/
- Part / Item #
- ANLM40AG, UDI/DI 191072232076
- Lot #
- 42-8868811
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What the firm is doing
American Contract Systems issued an "URGENT: MEDICAL DEVICE FIELD CORRECTION" on 5/19/2026 with a revision issued on 6/4/2026 via email. The notice explained the issue, risks to health, and requested the consignee affix a recall label from the template provided to the exterior of the kit. The label states: "URGENT: RECALL NOTIFICATION, Prior to use, remove & discard the Medicos Ritmed Neurological Sponge per ACS Recall FA-2026-034." Customers/end-users receiving the product through a distributor were directed to contact the distributor or sales representative with any questions. Complete the Recall Response Form. Distributors were directed to directed to ensure all end-users are appropriately notified and maintain records of effectiveness. If you have any questions, contact the Regulatory Affairs Manager, Global Products by email: GM-OMRA_RECALLS@owens-minor.com or phone at: 470.280.4277 .
DistributionShow detailsHide
US distribution to states of: MN, MO, IA
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2989-2026
- FDA device classification · OJGOfficial FDA classification for this device type
- CFR regulation · 21 CFR 882.4525The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find American Contract Systems IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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