| | Class 2 Device Recall American Contract Systems |  |
| Date Initiated by Firm | May 19, 2026 |
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| Date Posted | August 20, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2989-2026 |
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| Recall Event ID |
99482 |
| Product Classification |
Neurological tray - Product Code OJG
|
| 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. |
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| 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. |
| FEI Number |
3008492337
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Recalling Firm/
Manufacturer |
American Contract Systems Inc
85 Shaffer Park Dr
Tiffin OH 44883-9290
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| For Additional Information Contact | Marlene Jones
470-280-4277 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Nonconforming Material/Component |
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| 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 . |
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| Quantity in Commerce | 4789 kits |
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| Distribution | US distribution to states of: MN, MO, IA |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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