3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Lot Codes / Batch Numbers
Lot number 2006-12 AA through 2008-06 AB.
Products Sold
Lot number 2006-12 AA through 2008-06 AB.
A medical device manufacturer is recalling 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD due to 3M Comply 1248 Gas Plasma Chemical Indicator Strips were manufactured with a material that may cause some of the indicators to show an inaccurate resu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
3M Comply 1248 Gas Plasma Chemical Indicator Strips were manufactured with a material that may cause some of the indicators to show an inaccurate result if not read immediately after processing.
Recommended Action
Per FDA guidance
The firm initiated a recall of the Comply 1248 product made with the discrepant material. Customer letters were sent on August 14, 2006. Letters notified customers of problem and instructed them to discontinue distribution or use of the product. Then to return all affected product to them.
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