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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 192
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.
Part of a larger recall action
This product is one of 39 recalled by American Contract Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 39 products in this recall →Related recalls
Same manufacturer · American Contract Systems Inc
See all →- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- ModerateAmerican Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
FDA (Devices) · 2026-09-02
Same hazard · ethylene oxide
See all →- HighProcedure Tray Recalled for Excessive Ethylene Oxide Residuals
FDA (Devices) · 2024-07-17
- HighHand Procedure Kit Recalled for Excess Ethylene Oxide Residuals
FDA (Devices) · 2024-07-17
- HighArthroscopy Pack Recalled for Excessive Sterilization Chemical Residue
FDA (Devices) · 2024-07-17
- HighArthroscopy Procedure Tray Recalled for Excess Sterilization Residue
FDA (Devices) · 2024-07-17
- HighKnee Arthroscopy Procedure Kit Recalled for Sterilization Chemical Residue
FDA (Devices) · 2024-07-17
Similar recalls
- HighMedical Device Convenience Kits Recalled for Ethylene Oxide Residual Contamination
FDA (Devices) · 2025-06-18
- HighMedical Device Packs Recalled for Improper Sterilization Process
FDA (Devices) · 2023-11-01
- ModerateACS Cath Lab Packs Sterilized with Excess Ethylene Oxide
FDA (Devices) · 2022-05-18
- HighMedical device components subjected to improper sterilization process and elevated exposure
FDA (Devices) · 2023-11-01
- HighRobotics Pack I.V. Catheter and Adhesive Recalled for Sterilization Defect
FDA (Devices) · 2023-11-01
- HighBreast Plastics Pack Recalled for Potential Loss of Functionality Due to Sterilization Process
FDA (Devices) · 2023-11-01