3M Company - Health Care Business: Medical Device Recall in 2014 - (Recall #: Z-2002-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 9, 2014

Date Posted: July 16, 2014

Recall Number: Z-2002-2014

Event ID: 68415

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.

Status: Terminated

Product Quantity: 5343 (2621 USA, 2722 OUS)

Code Information:

All serial numbers.

Distribution Pattern:

Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of AUSTRALIA, CANADA, CHILE , COLOMBIA, COSTA RICA, SOUTH AFRICA, BRAZIL, GERMANY, ECUADOR, DUBAI, JAPAN, HONG KONG , CHINA, KOREA, MALAYSIA, PANAMA, SINGAPORE, VATICAN, and THAILAND.

Voluntary or Mandated:

Voluntary: Firm initiated