Surgical procedure kits recalled due to sterilization assurance concerns
American Contract Systems Inc is recalling hysterectomy procedure kits from IL and LA due to inability to confirm sterilization assurance requirements were met.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall where sterilization assurance cannot be confirmed. No illnesses, injuries, or hospitalizations have been reported. Medical procedure kits that may not be properly sterilized represent a risk-of-harm to patients undergoing surgery. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
American Contract Systems Inc is recalling two models of medical procedure kits used for hysterectomy surgeries: the Robot Hysterectomy Pack (Model GRRB10E) and the Vaginal Hysterectomy Pack (Model SPVH62P). The recall affects 50 units that were distributed to medical facilities in Illinois and Louisiana.
During an internal investigation, American Contract Systems Inc determined that the sterilization rationale for certain kit components was not justified and some components were not suitable for further sterilization according to company procedures. As a result, the company cannot confirm that product sterilization assurance requirements were met.
Healthcare facilities that received these kits should stop using them immediately. Surgical equipment that has not been confirmed to meet sterilization assurance requirements may not be safe for use in surgical procedures. Affected facilities should contact American Contract Systems Inc for instructions on returning or replacing the recalled kits.
The recalled kits have the following lot numbers: Robot Hysterectomy Pack GRRB10E (Lots 42-8157011 and 42-8126811) and Vaginal Hysterectomy Pack SPVH62P (Lots 12-7322911 and 12-7384911).
The recalled product
- 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.
- Manufacturer
- American Contract Systems Inc
- Hazard
- sterilization-assurance-failure
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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.
Distribution
Distributed in 2 states:
- IL
- LA
Related recalls
Same category
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03
- HighPhilips Azurion and Allura Imaging Systems Recalled for Hard Drive Degradation
FDA (Devices) · 2026-06-03
- HighPhilips Allura Imaging Systems Hard Drive Degradation Affects Functionality
FDA (Devices) · 2026-06-03
- ModerateMedtronic Deep Brain Stimulation Pocket Adaptor Kits recalled for incorrect expiration dates
FDA (Devices) · 2026-06-03
- SevereMedline spinal injection kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03