Preat Astra dental analogs have rotational feature 180 degrees off
Preat Astra EV-compatible 4.2 mm Digital Analogs are being recalled because a manufacturing error left the digital analog rotational feature 180 degrees off. 44 units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for a manufacturing orientation error on a laboratory component, with no patient harm or clinical consequence stated in the source.
Plain-English summary
The Preat Astra EV-compatible 4.2 mm Digital Analog, REF 9006603 (single) and 9006603-10 (10 pack), prescription only, is being recalled. The action covers 44 units.
The stated reason is that, due to a manufacturing error, the digital analog rotational feature is 180 degrees off. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Affected lots are 278735 and 278402. Distribution was nationwide in the United States, including Alabama, California, Florida, Georgia, Kentucky, Maryland, Minnesota, New York and Oklahoma. The analogs are supplied to dental practices and laboratories rather than sold to consumers.
Dental laboratories should identify affected stock using the REF and lot numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
- Manufacturer
- Preat Corp
- Hazard
- manufacturing-error
- rotational-orientation
- dental-analog
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots: 278735
- & 278402/UDI:
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22