3M Attest Biological Indicator caps may fail during steam sterilization
3M is recalling 79,500 Attest Super Rapid Readout Biological Indicators because the cap may melt, deform, or crack during steam sterilization cycles, potentially compromising sterilization validation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a specific manufacturing defect in a critical sterilization validation function. No illnesses, injuries, or deaths reported. The cap failure poses a risk to sterilization process reliability, warranting High severity per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
3M Company is recalling specific lots of 3M Attest Super Rapid Readout Biological Indicators (model 1492V) and related models (41482V, 41482VF, and 1496V). The affected devices have caps that may melt, deform, and/or crack when exposed to steam sterilization cycles at temperatures of 132°C or 135°C.
Biological indicators are devices used to qualify and monitor the effectiveness of steam sterilization cycles in healthcare settings. A failing cap could compromise the integrity of the indicator and affect sterilization validation. The recall involves approximately 79,500 devices distributed worldwide across the United States and 13 other countries, including Argentina, Australia, Belgium, Canada, China, Colombia, Hong Kong, Italy, Japan, Peru, Poland, South Korea, Spain, and Taiwan.
Healthcare facilities and sterilization centers should discontinue use of affected lots and contact 3M for replacement or further instructions. Affected lot codes are 33P3X3 (expiration 12/29/2024) and 33P4NH (expiration 01/01/2025), identified by UDI/DI codes 50707387762969 (shipper) and 30707387762965 (carton).
The recalled product
- Product
- 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles
- Manufacturer
- 3M Company - Health Care Business
- Hazard
- device-defect
- sterilization-failure-risk
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 (6)
- UDI/DI: 50707387762969 (shipper)
- 30707387762965 (carton)
- Lot codes: 33P3X3
- exp. 12/29/2024
- 33P4NH
- exp. 01/01/2025
Distribution
Distributed nationwide across the United States.
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