Preat — Class II medical device recall Z-2107-2025
Ongoing recall by Preat Corp, reported 2025-07-16, distributed nationwide. Due to manufacturing error, digital analog rotational feature is 180 degrees off.
| Recall number | Z-2107-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Preat Corp, Santa Maria, CA, United States |
| Recall initiated | 2025-06-24 |
| Classified | 2025-07-10 |
| Reported by FDA | 2025-07-16 |
| Distributed | Nationwide (US) |
| Quantity | 44 units |
| Lot numbers | 278402, 278735 |
| Model numbers | 9006603 |
Product
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Reason for recall
Due to manufacturing error, digital analog rotational feature is 180 degrees off.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2107-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.