Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Medium RiskFDA Device
Medical Devices/Surgical Equipment

Lower Extremity and Total Knee Packs Recalled for Chemical Residue

Agency Publication Date: June 6, 2025
Share:
Sign in to monitor this recall

Summary

American Contract Systems, Inc. is recalling approximately 850 Lower Extremity and Total Knee Packs because a component in these kits contains excessive chemical residue. The Specialist Blend Cast Padding included in these surgical convenience kits was found to have levels of Ethylene Oxide and Ethylene Chlorohydrin that exceed safety limits. No injuries have been reported to date.

Risk

The excessive chemical residue may cause the cast padding to lose functionality or fail. This could lead to a loss of product performance, resulting in delays or prolonged medical procedures and therapy for patients.

What You Should Do

  1. This recall involves American Contract Systems Lower Extremity and Total Knee Packs containing Specialist Blend Cast Padding (Item QTX30-322NS) with model numbers NCEX20I, NCEX20J, NCTK31K, and NCTK31L.
  2. Identify your kits by checking for the following lot numbers and expiration dates: 9146304 (2025-12-03), 9207685 (2026-01-08), 9222096 (2026-01-30), 9086225 (2025-11-01), or 9219596 (2026-01-15).
  3. Stop using the recalled product immediately.
  4. Contact American Contract Systems, Inc. or your medical supply distributor to arrange for the return, replacement, or correction of the affected kits.
  5. For additional questions, call the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: LOWER EXTREMITY kit
Model / REF:
NCEX20I
Lot Numbers:
9146304 (Exp 2025-12-03)
9207685 (Exp 2026-01-08)
UDI:
00191072222398

Contains Specialist Blend Cast Padding, Item: QTX30-322NS

Product: LOWER EXTREMITY kit
Model / REF:
NCEX20J
Lot Numbers:
9222096 (Exp 2026-01-30)
UDI:
00191072234582

Contains Specialist Blend Cast Padding, Item: QTX30-322NS

Product: TOTAL KNEE PACK kit
Model / REF:
NCTK31K
Lot Numbers:
9086225 (Exp 2025-11-01)
UDI:
00191072222480

Contains Specialist Blend Cast Padding, Item: QTX30-322NS

Product: TOTAL KNEE PACK kit
Model / REF:
NCTK31L
Lot Numbers:
9219596 (Exp 2026-01-15)
UDI:
00191072234872

Contains Specialist Blend Cast Padding, Item: QTX30-322NS

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96837
Status: Active
Manufacturer: American Contract Systems, Inc.
Sold By: American Contract Systems, Inc.
Manufactured In: United States
Units Affected: 850 Kits
Distributed To: Colorado

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.