FDA Device recall Z-2107-2025
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
- FDA Device
- Class II
- ongoing
- Published 2025-07-16
On 2025-07-16 the FDA classified a Class II recall of Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only by Preat, citing due to manufacturing error, digital analog rotational feature is 180 degrees off.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2107-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-24 |
| Published | 2025-07-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Preat |
| Distribution | US |
Product
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Reason
Due to manufacturing error, digital analog rotational feature is 180 degrees off.
Identifiers
| code_info | Lots: 278735, & 278402/UDI: |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2107-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.