Preat Corp recalls Preat
Reason for recall
Due to manufacturing error, digital analog rotational feature is 180 degrees off.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx OnlyAffected lot278735
What the firm is doing
On June 24, 2025 Preat Corporation issued a "Urgent: Medical Device Recall" to affected consignees via certified mail. Preat asked consignees to take following actions: 1. Immediately review your inventory for product listed in the table below. 2. Customers shall stop/cease use of the product in the scope of this recall. 3. It shall be discarded or returned to PREAT CORPORATION. Instructions for the return will be provided. 4. All personnel within your company should be made aware of the issue. Any customers to which this product has been further distributed should be provided a copy of this notification and informed to notify their customers. 5. Complete and return the Customer Response Form following completion of your reconciliation activities.
DistributionShow detailsHide
US Nationwide distribution in the states of AL, CA, FL, GA, KY, MD, MN, NY, OK, PA.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2107-2025
- FDA 510(k) clearance · K220823The device's official FDA premarket clearance record
- FDA device classification · NHAOfficial FDA classification for this device type
- CFR regulation · 21 CFR 872.3630The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Preat CorpSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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