3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack — Class II medical device recall Z-2639-2023

Ongoing recall by 3M Company - Health Care Business, reported 2023-10-04, distributed nationwide. Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Pl

Recall number	`Z-2639-2023`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	3M Company - Health Care Business, Saint Paul, MN, United States
Recall initiated	2023-08-22
Classified	2023-09-26
Reported by FDA	2023-10-04
Distributed	Nationwide (US)
Countries outside the US	AR, AU, BE, CA, CN, CO, ES, HK, IT, JP, KR, PE, PL, TW
Quantity	172,464 devices
Reason classes	packaging
UPC / GTIN / UDI-DI	`50707387787276`
Lot numbers	`33P3EF`, `33P4ND`, `33P4NR`, `33P5CA`, `33P5XT`
Model numbers	`41482V`
Expiration dates	`2024-12-27`, `2025-01-01`, `2025-01-03`, `2025-01-06`

Product

3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2639-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.