FDA Medical Device Recalls (openFDA)
Preat Corp: Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
- Recall number
- Z-2107-2025
- Recalling firm
- Preat Corp
- Product
- Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
- Status
- Open, Classified
- Initiated
- 2025-06-24
- Posted
- 2025-07-10
- Terminated
- not on file
- Reason
- Due to manufacturing error, digital analog rotational feature is 180 degrees off.
- Root cause
- Employee error
- Action
- 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.
- Quantity
- 44 units
- Distribution
- US Nationwide distribution in the states of AL, CA, FL, GA, KY, MD, MN, NY, OK, PA.
- Lot, serial or model codes
- Lots: 278735, & 278402/UDI:
- 510(k) numbers
- ["K220823"]
- PMA numbers
- not on file
- Product code
- NHA
- Firm FEI
- 2918719
- Firm city
- Santa Maria
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28