Attest recallZ-2638-2023 · 3M Company - Health Care Business · initiated Aug 22, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from 3M Company - Health Care Business or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 132C and 135C.
FDA root cause category: Process control
What the company is doing
3M issued an Urgent product recall notice to its consignees on 08/24/2023 by email and US mail. The notice explained the problem with the product and requested the following: Discontinue distribution of the product and dispose of the product. Distributors were directed to notify their customers. The firm is offering replacement with the return of the completed response form.
Recall details
- Recall number
- Z-2638-2023
- Status
- Open, Classified
- Initiated by the company
- Aug 22, 2023
- Posted by the FDA
- Sep 26, 2023
- Recalling firm
- 3M Company - Health Care Business
- Quantity
- 33504 devices
- Product code
- FRC
- FDA submissions
- K173519
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, China, Colombia, Hong Kong, Italy, Japan, Peru, Poland, South Korea, Spain, Taiwan.
Product description
3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes
Code information (models, lots, serial numbers)
UDI/DI: 50707387762983( (shipper); Lot codes: 33P4NJ, exp. 01/01/2025; 33P56T, exp. 01/02/2025
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Attest™ 1496V3m Company · Indicator, biological sterilization process1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 92915).
- Z-2637-2023 · Open, Classified3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles
- Z-2639-2023 · Open, Classified3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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