Medical procedure kits recalled due to unconfirmed sterilization
American Contract Systems is recalling 1,127 medical procedure kits distributed to Illinois and Louisiana because the manufacturer cannot confirm sterilization requirements were met for certain components.
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: Although classified as FDA Class II, no illnesses or injuries have been reported. However, medical procedure kits that lack confirmed sterilization represent a significant risk of harm through potential infection or contamination if used, fitting the rubric criterion for Score 3: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
American Contract Systems Inc is recalling 1,127 medical procedure kits and trays distributed to healthcare facilities in Illinois and Louisiana. The recall affects six models: CYSTO (Models ASCY24A and SACY80S), CYSTO PACK (Models BUCY78E and LMCP22T), TUR BASIN PACK (Model LMTU31T), and UROLOGY PACK (Model SPUR64F).
During an internal investigation, American Contract Systems determined that the rationale for sterilization of certain components was not justified, making some components unsuitable for sterilization according to the company's procedures. As a result, the manufacturer is unable to confirm that sterilization assurance requirements were met for the affected kits.
Healthcare facilities that received these recalled kits should discontinue use and contact American Contract Systems Inc for guidance on return or replacement. Additional information about this recall is available through the FDA using recall number Z-2466-2025.
The recalled product
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SA
- Manufacturer
- American Contract Systems Inc
- Hazard
- sterilization-failure
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 (20)
- 1) Model/Item Number ASCY24A: UDI/DI 00191072201621
- Kit Lot Numbers: 12-7370111
- 12-7388611
- 12-7139611
- 12-7191911
- 12-7231611
- 12-7263911
- 2) Model/Item Number BUCY78E: UDI/DI 00191072235350
- Kit Lot Numbers: 42-7962811
- 3) Model/Item Number LMCP22T: UDI/DI 00191072235510
- Kit Lot Numbers: 42-8027411
- 42-8106111
- 42-7885511
- 42-7823511
- 4) Model/Item Number LMTU31T: UDI/DI 00191072235527
- Kit Lot Numbers: 42-7987311
- 42-8059311
- 42-8112211
- 42-7832311
- 42-7845011
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