American Contract Systems recalls NEURO IR TRAY Model WENI56J due to possible failure in sterilization, risking treatment delays. Affected units have specific lot numbers and UDI-DI codes.
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
American Contract Systems is recalling their NEURO IR TRAY (Model WEN:56J) because it may not have been properly sterilized, which could cause treatment delays. This affects medical devices used in healthcare settings.
The device may not have been properly sterilized during manufacturing, which could lead to treatment delays or reduced functionality. This does not pose an immediate safety risk like injury or fire.
Healthcare facilities using the NEURO IR TRAY model WENI56J are likely affected. Staff handling the device may be at risk if sterilization issues cause treatment delays.
Check for the model number WENI56J on the device. Affected units have specific lot numbers: 893241, 71-051182, and 71-051813, or UDI-DI code 00191072217813.
Look for the model number WENI56J on the device to confirm if it's affected.
Reach out to American Contract Systems for specific guidance on affected units and next steps.
The recall is due to possible failure in sterilization assurance, which could lead to treatment delays or reduced functionality.
Check the model number and lot numbers to see if it's affected; contact American Contract Systems for further instructions.
The recall states possible treatment delays but does not mention injury risks, so it's considered low risk.
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-1355-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1355-2025 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.