LOWER EXTREMITY — Class II medical device recall Z-1916-2025
Ongoing recall by American Contract Systems, Inc., reported 2025-06-18, distributed nationwide. Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin
| Recall number | Z-1916-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Contract Systems, Inc., Chandler, AZ, United States |
| Recall initiated | 2025-04-21 |
| Classified | 2025-06-06 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 850 kits |
| Reason classes | chemical contamination |
| UPC / GTIN / UDI-DI | 00191072222398, 00191072222480, 00191072234582, 00191072234872 |
| Model numbers | NCEX20I, NCEX20J, NCTK31K, NCTK31L, QTX30-322NS |
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
Reason for recall
Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that may lead to a delay or prolonged treatment/procedure/therapy.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1916-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.