3M Attest Auto-reader — Class II medical device recall Z-2002-2014
Terminated recall by 3M Company - Health Care Business, reported 2014-07-16, distributed nationwide. Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product contains dry nat
| Recall number | Z-2002-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | 3M Company - Health Care Business, Saint Paul, MN, United States |
| Recall initiated | 2014-06-09 |
| Classified | 2014-07-07 |
| Reported by FDA | 2014-07-16 |
| Terminated | 2015-06-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, CN, CO, CR, DE, EC, HK, JP, KR, MY, PA, SG, TH, ZA |
| Reason classes | labeling |
| Model numbers | 390, 490 |
Product
3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.
Reason for recall
Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product contains dry natural rubber" as required by the United States Food and Drug Administration (FDA) for medical devices. The non-slip pads at the bottom of the unit contain dry natural rubber. One incident of an allergic reaction in a sensitized individual has been reported.
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-2002-2014. 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.