HIGH

American Contract Systems Recalls 32,433 Medical Convenience Kits Over Re-Gassing Risk (2025)

American Contract Systems recalled 32,433 medical convenience kits sold through multiple retailers nationwide. The devices were re-gassed after a nonconformance in the Ethylene Oxide gas injection process and have not been validated for exposure to multiple sterilization cycles. Healthcare providers and patients should stop using these products immediately and follow the manufacturer's recall.

Quick Facts at a Glance

Recall Date
September 4, 2025
Hazard Level
HIGH
Brand
American Contract Systems
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

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 are bundled supplies used by hospitals and clinics to support a range of procedures. They include various pack components designed for sterile environments.

Why This Is Dangerous

The EO sterilization process for these items did not pass a re-sterilization validation, meaning repeated sterilization could compromise quality and effectiveness.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

Hospitals may need to halt procedures using these kits until replacements are obtained. The recall may affect supply chains for sterile procedure packs and could delay certain medical activities.

Practical Guidance

How to identify if yours is affected

  1. Review item numbers listed in the recall notice.
  2. Check UDI-DI and lot numbers printed on each kit’s bag and packaging.
  3. Compare your inventory to the affected model list.

Where to find product info

Identify UDI-DI, lot numbers, and bag serial numbers on the kit packaging and labels.

What timeline to expect

4-8 weeks for recall remedy processing and replacement instructions.

If the manufacturer is unresponsive

  • Document every contact attempt.
  • Escalate to hospital risk management and FDA if the supplier does not respond within a reasonable period.

How to prevent similar issues

  • Verify sterilization validation for reused medical devices.
  • Prefer single-use sterile packs when possible.
  • Keep a current inventory of medical device packs and monitor recall notices.

Documentation advice

Save all recall notices, photos of labels, serial numbers, and all correspondence with the supplier.

Product Details

Model numbers involved: AKGN82E, AMCB08Y, ANBP10AC, ANIR77AM, CFLA39G, CIBL33I, EVMN24E, EVST48E, FDTA11AA, FHHY25P, HGML99G, HGXR41H, HISU54M, IHAA19AP, IHMP89K, IHPD14AM, LKVG10O, LMAG20G, LMLE46AA, MIEN58A, NUMB04H, OWBS11U, RCMS71B, SFMB55X, STBA09F, TNBS21O, UDBH37AX, UDMA50X, UICR54W, UIPC89D, UIPT13F, UISB96AB. Distribution: US nationwide. Sold to hospitals and medical facilities. Recall date: 2025-09-04. Sold price: Unknown. Quantity: 32,433 units.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 32,433 units recalled
  • 32 item numbers listed
  • US nationwide distribution in SD, IA, MN, WA, IL
  • Re-gassed after EO sterilization nonconformance; not validated for multiple cycles
  • Class II recall; high-hazard device
  • Recall date 2025-09-04; Report date 2025-10-22

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
AKGN82E
AMCB08Y
ANBP10AC
ANIR77AM
CFLA39G
+27 more
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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