CLASS II ONGOING Device recall · Reported 16 Jul 2025 · FDA Enforcement Report

Astra EV-compatible Digital Analog recalled by Preat

Preat is recalling Astra EV-compatible Digital Analog, distributed nationwide in the US. The recall was initiated on 24 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: 278735, & 278402/UDI:

Quantity recalled44 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2107-2025
FDA event ID: 97136
Recalling firm: Preat, Santa Maria, CA
Classification: Class II
Status: Ongoing
Recall initiated: 24 Jun 2025
FDA classified: 10 Jul 2025
Reported: 16 Jul 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

24 Jun 2025	Recall initiated by company
10 Jul 2025	Classified by FDA	+16 days
16 Jul 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to manufacturing error, digital analog rotational feature is 180 degrees off.

Product as listed by the FDA

Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only

Where it was distributed

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

Nationwide Alabama California Florida Georgia Kentucky Maryland Minnesota New York Oklahoma Pennsylvania

Questions about this recall

Why was it recalled?

Due to manufacturing error, digital analog rotational feature is 180 degrees off.

Which lots are affected?

Lots: 278735, & 278402/UDI:

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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