HIGH

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

American Contract Systems Inc. recalls 32,433 medical convenience kits distributed nationwide to healthcare facilities in SD, IA, MN, WA, and IL. Re-gassed after a nonconformance occurred during Ethylene Oxide gas injection. The kits have not been validated for multiple sterilization cycles. Healthcare providers should stop using the devices immediately and follow recall instructions.

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

Get instant alerts for Health & Personal Care recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

About This Product

Medical convenience kits are intended to provide sterile packs for obstetric procedures, including cesarean sections. They are used in operating room or hospital settings by healthcare professionals.

Why This Is Dangerous

Re-gassing after a nonconformance during EO sterilization may affect sterility, safety, and effectiveness. The products have not been validated for exposure to multiple sterilization cycles.

Industry Context

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

Real-World Impact

Hospitals may need to halt use of affected kits, re-check inventory, and coordinate with the manufacturer for guidance on replacements or refunds. Potential risk to patients if compromised sterility is used in procedures.

Practical Guidance

How to identify if yours is affected

  1. Identify model numbers FHCP08Y, HICS50I, HSCB90B on packaging or labeling.
  2. Match UDI-DI numbers 191072232724, 191072212351, 191072141606 and associated lot numbers.
  3. If bag serial numbers are provided, verify listed serials; if bag serial is listed as N/A, the whole lot is affected.

Where to find product info

Refer to the recall notice and the FDA enforcement page for Z-0181-2026; manufacturer communications will include specifics.

What timeline to expect

Replacements or refunds, if offered, will be communicated by the manufacturer. Timeline varies by facility and recall response plan.

If the manufacturer is unresponsive

  • Document all communications with the manufacturer.
  • Escalate to hospital risk management if the supplier is unresponsive.
  • Consider contacting the FDA for guidance if the issue remains unresolved.

How to prevent similar issues

  • Verify sterilization validation before re-using EO-sterilized devices.
  • Ask suppliers for validated EO sterilization cycles and lot-specific certificates.
  • Maintain an auditable recall process and inventory controls for sterilized medical kits.

Documentation advice

Keep the recall notice, supplier communications, inventory logs, and any returned items documentation for records.

Product Details

Product: Medical convenience kits. Item Numbers: FHCP08Y (C SECTION PK), HICS50I (C-SECTION PACK), HSCB90B (C-SECTION BASIN PACK). UDI-DI: FHCP08Y 191072232724, HICS50I 191072212351, HSCB90B 191072141606. Lot numbers: 8216211, 8161711, 8083511. Quantity: 32,433 total. Sold to: Healthcare facilities nationwide. States listed for distribution: SD, IA, MN, WA, IL. Recall date: 2025-09-04. Report date: 2025-10-22. Status: ACTIVE. Manufacturer: American Contract Systems Inc. Recall number: Z-0181-2026. Distribution: US nationwide.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 32,433 total units recalled
  • Models affected: FHCP08Y, HICS50I, HSCB90B
  • U DI-DI references: 191072232724, 191072212351, 191072141606
  • Bag serial numbers: 68258296, 68273637, 47506618, 47508489
  • States of distribution: SD, IA, MN, WA, IL
  • Recall date: 2025-09-04 with active status
View Original Recall on FDA - Medical Devices

Browse More Recalls

More from FDA_DEVICEHealth & Personal CareMedical Devices

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

Get Alerts for Health & Personal Care Recalls

Get instant alerts for recalls that affect you. Free forever.

Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeSurgical sterilization kit
Sold At
Multiple Retailers

Product Details

Model Numbers
FHCP08Y
HICS50I
HSCB90B
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
HIGH

American Contract Systems Recalls 32,433 Basic Biopsy Trays Re-Gassed After EO Sterilization (2025)

American Contract Systems recalled 32,433 basic biopsy trays distributed nationwide in the United States. These trays were re-gassed after a nonconformance occurred during the initial Ethylene Oxide gas injection. The trays have not been validated for exposure to multiple sterilization cycles. Healthcare providers and patients should stop using affected trays and follow recall instructions.

American Contract Systems
Identified products
Read more
Health & Personal Care
HIGH

American Contract Systems Recalls 32,433 Cardiac Cath Lab Kits Due to Re-Gassed Sterilization Risk (

American Contract Systems recalled 32,433 cardiac cath lab kits distributed nationwide to healthcare providers. The devices were re-gassed after a nonconformance in the Ethylene Oxide gas injection process. The kits have not been validated for exposure to multiple sterilization cycles and cannot be guaranteed safe.

American Contract Systems
Identified products
Read more
Health & Personal Care
HIGH

American Contract Systems Basic Biopsy Tray Recalled for Re-Gassing Hazard (32,433 Units) 2025Recall

American Contract Systems recalled 32,433 Basic Biopsy Trays nationwide after discovering re-gassing occurred following a nonconformance during Ethylene Oxide sterilization. The trays have not been validated for exposure to multiple sterilization cycles, so product quality and safety cannot be confirmed. Healthcare providers and patients should stop using the device immediately and follow theメーカー?

American Contract Systems
Identified products
Read more
Health & Personal Care
HIGH

American Contract Systems LKRA40G Radiology Pack Recalled Over Unvalidated Re-sterilization (HIGH)

American Contract Systems recalled 32,433 radiology packs after a nonconformance during EO gas injection. The items were re-gassed and not validated for multiple sterilization cycles. The recall is active as of 2025-10-22. US distribution included SD, IA, MN, WA, IL. Health risks prompt immediate removal from use.

American Contract Systems
Identified products
Read more
Health & Personal Care
HIGH

American Contract Systems Recalled 32,433 Orthopedic Surgical Kits Over Re-Gassing Risk (2025)

American Contract Systems recalled 32,433 medical convenience kits sold through multiple retailers nationwide in SD, IA, MN, WA and IL. The devices were re-gassed after a nonconformance in the Ethylene Oxide sterilization process. The sterilization cycles have not been validated, so quality, safety and effectiveness cannot be confirmed. Consumers and healthcare providers should stop using the kits

American Contract Systems
Identified products
Read more
Health & Personal Care
HIGH

American Contract Systems IHDC30R D AND C PACK Medical Kits Recalled Over Re-Gassing (32,433 Units,

American Contract Systems recalled the IHDC30R D AND C PACK medical convenience kits distributed nationwide in the United States. The recall stems from a nonconformance during Ethylene Oxide gas injection that led to re-gassing. The products have not been validated for exposure to multiple sterilization cycles. Health safety cannot be confirmed for re-gassed units. Stop using them and await recall

American Contract Systems
Identified products
Read more
Health & Personal Care
HIGH

American Contract Systems Labor Delivery Packs Recalled for Re-Gassed Sterilization Flaw (2025)

American Contract Systems recalled 32,433 labor and delivery packs nationwide in the United States, including the states of South Dakota, Iowa, Minnesota, Washington and Illinois. Re-gassing occurred after a nonconformance in the Ethylene Oxide gas injection process. The affected packs have not been validated for exposure to multiple sterilization cycles. Hospitals and health systems should stop使用

American Contract Systems
Identified products
Read more
Health & Personal Care
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.

American Contract Systems
Identified products
Read more