Astra EV Digital Analog (Preat) – Rotational Misalignment (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
Brand
Preat Corp
Lot Codes / Batch Numbers
Lots: 278735, & 278402/UDI:
Products Sold
Lots: 278735, & 278402/UDI:
Preat Corp is recalling Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx On due to Due to manufacturing error, digital analog rotational feature is 180 degrees off.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to manufacturing error, digital analog rotational feature is 180 degrees off.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026