FDA Device recall Z-2002-2014
3M Attest Auto-reader
- FDA Device
- Class II
- terminated
- Published 2014-07-16
On 2014-07-16 the FDA classified a Class II recall of 3M Attest Auto-reader by 3m Health Care Business, citing 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 Administr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2002-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-09 |
| Published | 2014-07-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | 3m Health Care Business |
| Distribution | US |
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
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.
Identifiers
| code_info | All serial numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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All 3m Health Care Business recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2002-2014%22
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