3M Attest Super Rapid Readout Biological Indicator — Class II medical device recall Z-2637-2023
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-2637-2023 |
|---|---|
| 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 | 79,500 devices |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 30707387762965, 50707387762969 |
| Lot numbers | 33P3X3, 33P4NH |
| Model numbers | 1492V |
| Expiration dates | 2024-12-29, 2025-01-01 |
Product
3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles
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-2637-2023. 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.