—#215334

Product

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.

FDA product code: OJF — Hysterectomy Kit
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: 1) MODEL/ITEM NUMBER GRRB10E: UDI/DI 00191072236371, Kit Lot Numbers: 42-8157011, 42-8126811; 2) MODEL/ITEM NUMBER SPVH62P: UDI/DI 00191072238771, Kit Lot Numbers: 12-7322911, 12-7384911.

Why it was recalled

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Owens & Minor issued an "URGENT: MEDICAL DEVICE CORRECTION" notice to its consignees on 07/15/2025 via email. The notice explained the problem, potential risk to health, and requested the following: ACTIONS TO TAKE: " Discontinue use of all affected components. " Add warning labels to affected procedure trays to ensure the components are discarded. A labeling template is enclosed for printing labels which can be affixed on all affected kits in inventory. This label should be applied to each affected procedure tray and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. o Customers (end-users): If you receive a product from a distributor, please contact the distributor or your sales representative with any questions you may have. o Distributors: If any of the affected procedure trays identified above were further distributed, please ensure all end-users are appropriately notified of this product correction and maintain records of effectiveness for your consignees. " Complete the attached Recall Response Form and return as soon as possible to GM-OMRA_RECALLS@owens-minor.com. Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com. If you have any questions, contact the Manager, Regulatory Affairs at 470-280-4277 or email to: GM-OMRA_RECALLS@owens-minor.com.

Recalling firm

Firm: American Contract Systems Inc
Address: 85 Shaffer Park Dr, Tiffin, Ohio 44883-9290

Distribution

Distribution pattern: US distribution to states of: IL and LA

Timeline

Recall initiated: 2025-07-14
Posted by FDA: 2025-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215334. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.