HIGH

American Contract Systems High-Rire Recall: 32,433 Medical Convenience Kits Recalled for Re-GassedEO

American Contract Systems recalled 32,433 medical convenience kits nationwide after finding re-gassed devices from EO sterilization. The recall affects five product lines with UDI-DI codes and Lot numbers. The re-gassing process has not been validated for multiple sterilization cycles, calling into question product safety and effectiveness. Health providers and patients should stop using these kit

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

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

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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

  1. Match model and UDI-DI to recall list
  2. Check lot numbers against 7992111, 8082511, 8078511, 8048811, 7969711
  3. 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.

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
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPREGNANTPETS
Injury Types
ELECTRICALPOISONINGLACERATIONOTHER

Product Classification

Product TypeSterilization/Reusable Medical Kits
Sold At
Unknown

Product Details

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
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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