Lower riskMedical device recall · FDA · Published April 21, 2025
American Contract Systems Recalls Cast Padding Kits with EO/ECH Residuals
American Contract Systems recalls specific cast padding kits due to ethylene oxide/ethylene chlorohydrin residuals exceeding safety limits, potentially causing treatment delays or complications.
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.
Take action
Contact the company
📍Recalling firmAmerican Contract Systems, Inc.7300 W Detroit St · Chandler, AZ 85226-2410
“American Contract Systems Recalls Cast Padding Kits with EO/ECH Residuals.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52438-american-contract-systems-recalls-cast-padding-kits-with-eo-ech. Based on FDA recall #Z-1916-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1916-2025%22&limit=1).
The FDA announced on April 21, 2025, that American Contract Systems Inc. is voluntarily recalling lower extremity and total knee pack kits due to excessive Ethylene Oxide residuals. The agency said the hazard may lead to a loss of functionality or delay in treatment.
How to tell if you have it
Brand: American Contract Systems
LOWER EXTREMITY, Model: NCEX20I
LOWER EXTREMITY, Model: NCEX20J
TOTAL KNEE PACK, Model: NCTK31K
TOTAL KNEE PACK, Model: NCTK31L
The hazard
The FDA said test results for the cast padding component in the procedure trays showed Ethylene Oxide/Ethylene Chlorohydrin residuals exceeded limits. This may lead to a possible loss or lack of functionality that may lead to a delay or prolonged treatment, procedure, or therapy.
Context
GovInfoNow's records show American Contract Systems Inc has 21 other recalls on record since November 21, 2018. Other recent recalls include the August 10, 2026 recall of medical convenience kits containing BD CliniClean Pericare Wipes and the June 29, 2026 recall of catheters that may not meet performance standards. Similar recent recalls of comparable products include the April 21, 2026 Arrow Paracentesis Kit recall for contaminated medication risk and the July 10, 2026 Medline Convenience Kits recall for contaminated components.
How to tell if you have this one
Check for the model numbers NCEX20I, NCEX20J, NCTK31K, or NCTK31L on the kit. The kits were sold with specific expiration dates and lot numbers listed in the recall notice.
Brand
American Contract Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Identify the model number and expiration date on the kit to confirm if it is recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of CO.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 58 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1916-2025 (April 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1916-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.