American Contract Systems recalls ACL cast padding with catalog number LMAC10AA due to excessive ethylene oxide/ethylene chlorohydrin residuals, potentially causing tissue damage with prolonged use.
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
American Contract Systems is recalling ACL cast padding (catalog number LMAC10: 666231, 931241) because ethylene oxide and ethylene chlorohy: 10993-7 standards. This could cause tissue damage if the padding is used for extended periods.
Ethylene oxide and ethylene chlorohydrin residuals in the cast padding exceed safety limits for long-term use. This could lead to tissue damage if the padding is worn for extended periods.
People who own or use the ACL cast padding with catalog number LMAC10AA (lot numbers 666231 and 931241) are affected. Those using the product for extended periods are at higher risk.
Check for catalog number LMAC10AA on the product. Lot numbers 666231 and 931241 are associated with this recall.
Look for catalog number LMAC10AA and lot numbers 666231 or 931241 on the cast padding.
The recall states that ethylene oxide and ethylene chlorohydrin residuals exceed safety limits for long-term use, which could cause tissue damage. However, the remedy is not specified, so the risk is low for typical use.
The recall does not specify a remedy, so no action is required. Check the product details to confirm if it is affected.
Check for catalog number LMAC10AA and lot numbers 666231 or 931241 on the product.
We’ve drafted a message you can send American Contract Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2289-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2289-2024 from American Contract Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.