FDA Medical devices recall ·
EAR PACK , Model No SFEA12A recall
- Recall number
- Z-1351-2025
- Date
- (initiated February 6, 2025)
- Company / brand
- American Contract Systems Inc
85 Shaffer Park Dr, Tiffin, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 51 kits
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
EAR PACK , Model No SFEA12A
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI 00191072167446 Lots 968241 888241 70-052114 70-052727 70-053132
Distribution
US Nationwide distribution in the state of OH.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1351-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.