Quick Facts at a Glance
- Recall Date
- September 4, 2025
- Hazard Level
- HIGH
- Brand
- American Contract Systems
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- American Contract Systems
- Product type
- Sterilization/Reusable Medical Kits
- Model numbers
- BFCT04X UDI-DI 191072225955 Lot 7992111, CMEY17AI UDI-DI 191072211514 lot 8082511, PERP25AQ UDI-DI 191072199720 lot 8078511, RFEY50AC UDI-DI 191072202918 lot 8048811, UIVT47AS UDI-DI 191072224569 lot 7969711
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 4, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact American Contract Systems Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
Medical convenience kits used in clinical settings to streamline patient care. These kits include cataract, eye, and retinal packs.
Why This Is Dangerous
Re-gassing after EO sterilization may affect sterility and product performance leading to potential infection risk if compromised.
Industry Context
This recall is not clearly part of a broader industry pattern in the provided data.
Real-World Impact
Disruption in clinical workflows if kits are suspected unsafe; potential waste of sterile supplies; impact on patient safety.
Practical Guidance
How to identify if yours is affected
- Match model and UDI-DI to recall list
- Review shipment records for dates in 2025
Where to find product info
Look on the kit label for UDI-DI and lot numbers; FDA recall page Z-0185-2026
What timeline to expect
Recall processing timelines vary; consult FDA and manufacturer communications for refunds/replacements; expect weeks to months
If the manufacturer is unresponsive
- Document all correspondence
- Escalate to hospital recall coordinator
- File a consumer complaint with CPSC if necessary
How to prevent similar issues
- Verify sterilization validation before use
- Prefer single-use sterile kits when available
- Request clear sterilization documentation from suppliers
- Keep records of lot numbers and UDI-DI for recalls
Documentation advice
Keep product packaging, labeling, recall notices, and correspondence with the manufacturer.
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Product Details
Brand: American Contract Systems. Models: BFCT04X UDI-DI 191072225955 Lot 7992111; CMEY17AI UDI-DI 191072211514 lot 8082511; PERP25AQ UDI-DI 191072199720 lot 8078511; RFEY50AC UDI-DI 191072202918 lot 8048811; UIVT47AS UDI-DI 191072224569 lot 7969711. Sold nationwide in the United States. Distribution states: SD, IA, MN, WA, IL. Quantity: 32,433 units. Classification: Class II. Recall date: 2025-09-04. Report date: 2025-10-22.
Reported Incidents
No specific injuries or incidents are reported in the provided data.
Key Facts
- 32,433 total units recalled
- Five listed product lines with distinct UDI-DI and lot numbers
- Re-gassed after EO sterilization nonconformance
- No validation for multiple sterilization cycles
- Class II recall with nationwide US distribution
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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