Recall Z-2107-2025— Preat Corp
Class II · Ongoing
Class II FDA medical device recall by Preat Corp, initiated 2025-06-24. It names one FDA 510(k) clearance: K220823. 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..
- Recalling firm
- Preat Corp
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-24
- Firm location
- Santa Maria, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.