FDA recall Z-2107-2025

Preat Corp · Class II · device

Product

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.

Distribution

US Nationwide distribution in the states of AL, CA, FL, GA, KY, MD, MN, NY, OK, PA.

Key facts

Status
Ongoing
Initiation date
2025-06-24
Report date
2025-07-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Maria, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2107-2025