FDA Medical devices recall ·
Preat, Astra EV-compatible 4.2mm Digital Analog recall
- Recall number
- Z-2107-2025
- Date
- (initiated June 24, 2025)
- Company / brand
- Preat Corp
2625 Skyway Dr Ste B, Santa Maria, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 44 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Why was it recalled?
Due to manufacturing error, digital analog rotational feature is 180 degrees off.
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
Lots: 278735, & 278402/UDI:
Distribution
US Nationwide distribution in the states of AL, CA, FL, GA, KY, MD, MN, NY, OK, PA.
States: Alabama California Florida Georgia Kentucky Maryland Minnesota New York Oklahoma Pennsylvania
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-2107-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.