Upper Extremity Cast Padding Recalled for Excessive Sterilization Gas Residuals
American Contract Systems Inc. is recalling 192 units of cast padding due to excessive ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for skin-contact medical devices.
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 a skin-contact medical device with excessive residuals of sterilization chemicals (ethylene oxide and ethylene chlorohydrin) known to cause irritation and sensitization. Although no illnesses have been reported, the FDA's Class II classification and regulatory standard violations create a documented risk of harm that warrants High severity.
Plain-English summary
American Contract Systems Inc. is recalling 192 units of UPPER EXTREMITY PK, STRL F G cast padding (Catalog Number: IHUE40AG), distributed nationwide in the United States. This product is used in upper extremity casting applications.
The recall was issued because residuals of ethylene oxide (EO) and ethylene chlorohydrin (ECH)—chemicals used in device sterilization—exceeded the permissible limits for permanent skin-contact medical devices as specified in ANSI/AAMI/ISO 10993-7:2012. These sterilization gases can cause skin irritation and sensitization with prolonged contact, and residuals must remain within established safety limits.
Patients and healthcare providers who have received or used this product should discontinue use. Healthcare facilities should identify and quarantine affected inventory. The affected product lot numbers are 658231, 953241, and 899241 (UDI-DI: 00191072207791). Contact American Contract Systems Inc. for information on returns or replacements.
The recalled product
- Product
- UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG
- Manufacturer
- American Contract Systems Inc
- Hazard
- ethylene-oxide
- ethylene-chlorohydrin
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 (1)
- UDI-DI:00191072207791 LOT#"s: 658231 953241 899241
Distribution
Distributed nationwide across the United States.
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