3M Attest Super Rapid Readout Steam Challenge Pack — Class II medical device recall Z-2638-2023
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-2638-2023 |
|---|---|
| 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 | 33,504 devices |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 50707387762983 |
| Lot numbers | 33P4NJ, 33P56T |
| Model numbers | 1496V |
| Expiration dates | 2025-01-01, 2025-01-02 |
Product
3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; 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-2638-2023. 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.