Reported Mar 26, 2025 · Ongoing
EAR PACK , Model No SFEA12A
American Contract Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems Inc · 85 Shaffer Park Dr · Tiffin, OH · 44883-9290
Is this the product you have?
- EAR PACK , Model No SFEA12A
- Lot codes and dates
- UDI-DI 00191072167446 Lots 968241 888241 70-052114 70-052727 70-053132
- Amount recalled
- 51 kits
This recall covers 33 products
The agency filed one notice per product. You are reading one of them; the other 32 are below.
20 more are in the archive.
Where it was sold
- Nationwide
- OH
Why it was recalled
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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