TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01

Recall Insight

This FDA Devices action (record #Z-1321-2016) was formally reported on April 13, 2016, with the manufacturer initiating the action on March 3, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. ArthroCare Corporation is listed as the recalling firm, operating out of Austin, TX. Federal records indicate 26,903 devices units are affected.

The documented reason for this recall is: During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels. Distribution data in the federal record shows the product reached: Worldwide Distribution-US (nationwide) and the following countries-Austria, Belgium, Bulgaria, Canada, Denmark, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Ireland, Israel, Italy, Latvia, Nether…. 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 10 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.