Medical Device Convenience Kits Recalled for Ethylene Oxide Residual Contamination
American Contract Systems, Inc. is recalling convenience kits containing cast padding due to elevated ethylene oxide and ethylene chlorohydrin residuals that may cause loss of functionality and delay treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall with a risk of harm (loss of cast functionality and delayed treatment) where no illnesses or injuries have been reported. Per the rubric, such risk-of-harm products where injury has not yet been reported are classified as High (score 3).
Plain-English summary
American Contract Systems, Inc. is recalling four models of medical device convenience kits nationwide in Colorado: Lower Extremity Models NCEX20I and NCEX20J, and Total Knee Pack Models NCTK31K and NCTK31L. All kits contain Specialist Blend Cast Padding (Item QTX30-322NS). Approximately 850 kits are affected.
Test results show that ethylene oxide and ethylene chlorohydrin (EO/ECH) residuals in the cast padding component exceeded acceptable limits. These elevated residuals may lead to a loss or lack of functionality in the cast padding, which could result in delayed or prolonged treatment, procedures, or therapy.
Patients or healthcare facilities who have received or are using these kits should contact American Contract Systems, Inc. for further guidance. The specific lot numbers and expiration dates for each model are documented in the FDA recall notice Z-1916-2025.
The recalled product
- Product
- LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain Specialist Blend Cast Padding, Item: QTX30-322NS
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- ethylene-oxide-residual
- loss-of-functionality
- treatment-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Model/UDI-DI/Lot(Expiration): NCEX20I/00191072222398/9146304(2025-12-03)
- 9207685(2026-01-08)
- NCEX20J/00191072234582/9222096(2026-01-30)
- 9222096(2026-01-30)
- NCTK31K/00191072222480/9086225(2025-11-01)
- 9086225(2025-11-01)
- NCTK31L/00191072234872/9219596(2026-01-15)
- 9219596(2026-01-15)
Distribution
Distributed nationwide across the United States.
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