3M Attest 1264P Biological Indicators, in boxes of 25 per box Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
3M Attest 1264P Biological Indicators, in boxes of 25 per box
Lot Codes / Batch Numbers
Lot numbers 2005-07 DW, 2005-08 DD, and 2005-08 DL
Products Sold
Lot numbers 2005-07 DW, 2005-08 DD, and 2005-08 DL
A medical device manufacturer is recalling 3M Attest 1264P Biological Indicators, in boxes of 25 per box due to The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the posi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. The color on a positive control may revert to negative after 24 hours of incubation.
Recommended Action
Per FDA guidance
The firm conducted a field correction which began on 10/24/03. They provided revised labeling for the product. Letters, dated October 24, 2003, were sent to consignees. The letters had a description of the problem, instructions for doing the relabeling in the field, and recommendations for users of the product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026