3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape

Recall Insight

This FDA Devices action (record #Z-0252-2023) was formally reported on November 30, 2022, with the manufacturer initiating the action on October 6, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. 3M Healthcare Business is listed as the recalling firm, operating out of Saint Paul, MN. Federal records indicate 84,000 units units are affected.

The documented reason for this recall is: During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observ… Distribution data in the federal record shows the product reached: Worldwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.