American Contract Systems recalls EAR PACK Model SFEA12A due to possible sterilization issues causing treatment delays. Affected units have specific lot numbers and were sold in the U.S. Learn what to do.
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 its EAR PACK Model SFEA12A because it may not have been properly sterilized, which could lead to treatment delays. This affects medical devices used in healthcare settings.
The device may not have been properly sterilized, which could lead to treatment delays. This is a risk to healthcare providers and patients using the device in medical settings.
Healthcare providers using the EAR PACK Model SFEA12A for medical procedures are most likely affected. Patients receiving treatment with this device may experience delays.
Check for the model number SFEA12A on the device. The product was sold with specific lot numbers: 968241, 8882: 888241, 70-052114, 70-052727, 70-053132.
Look for the model number SFEA12A on the EAR PACK device.
The recall is due to possible failure in sterilization assurance, which could lead to treatment delays.
The official recall notice does not specify a remedy, so contact American Contract Systems for guidance.
Yes, affected units include lot numbers 968241, 888241, 70-052114, 70-052727, and 70-053132.
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-1351-2025 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1351-2025 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.
