Cast Padding Convenience Kits Recalled for Chemical Residue
American Contract Systems recalled 850 orthopedic convenience kits containing cast padding with ethylene oxide and ethylene chlorohydrin residues exceeding safe limits. The contamination may cause device dysfunction and delay patient medical 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 medical device recall involving chemical residue contamination that may affect device functionality. Although no injuries have been reported, the source identifies this as a risk-of-harm product where residue levels exceeded safe limits and could impair patient care delivery, justifying a High severity classification.
Plain-English summary
American Contract Systems, Inc. has issued a recall of 850 orthopedic convenience kits due to chemical contamination in cast padding. The affected kits (models NCEX20I, NCEX20J, NCTK31K, and NCTK31L) contain Specialist Blend Cast Padding (Item QTX30-322NS) included in lower extremity and total knee procedure kits.
Testing revealed that ethylene oxide and ethylene chlorohydrin residues in the cast padding exceeded permissible residual limits. These excess chemical residues may result in loss of device functionality, potentially delaying or prolonging patient treatment and procedures.
The kits were distributed nationwide with specific distribution in Colorado. The FDA classified this as a Class II recall. No injuries or adverse events have been reported.
Healthcare facilities and providers who received affected kits should verify inventory against the lot and model numbers provided and contact American Contract Systems regarding replacement options.
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
- chemical-residue
- ethylene-oxide
- device-dysfunction
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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