[Recalled] 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles — Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3… | FDA 202

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132¿C and 135¿C.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from 3M Company - Health Care Business

• 3M Attest Steam Chemical Integrators, REF 1243B — Class II
• ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7 — Class II
• 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM. — Class II
• 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. Impression Materials are composed of hydrophilic vinyl polysiloxane impression materials, designed for m — Class II
• 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000) — Class II
• 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush. Product is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth. — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.