3M Attest Steam Chemical Integrators — Class II medical device recall Z-1610-2023
Ongoing recall by 3M Company - Health Care Business, reported 2023-05-24, distributed nationwide. 3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 h
| Recall number | Z-1610-2023 |
|---|---|
| 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 | 2023-04-06 |
| Classified | 2023-05-18 |
| Reported by FDA | 2023-05-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BO, BR, CA, CH, CO, CZ, DE, EC, EE, ES, FI, FR, HK, ID, IN, JP, KR, MX, MY, NZ, PL, SA, SE, SK, TH, TW, VN |
| Quantity | 2,235,000 units |
| Reason classes | chemical contamination, packaging |
| UPC / GTIN / UDI-DI | 30707387785742, 50707387785746 |
| Lot numbers | EG112025, ET012026 |
| Model numbers | 1243B |
Product
3M Attest Steam Chemical Integrators, REF 1243B
Reason for recall
3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.
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-1610-2023. 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.