FDA Medical Device Recalls (openFDA)
American Contract Systems Inc: 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.
- Recall number
- Z-2989-2026
- Recalling firm
- American Contract Systems Inc
- 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.
- Status
- Open, Classified
- Initiated
- 2026-05-19
- Posted
- 2026-08-20
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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 .
- Quantity
- 4789 kits
- Distribution
- US distribution to states of: MN, MO, IA
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJG
- Firm FEI
- 3008492337
- Firm city
- Tiffin
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28