MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.

Recall Insight

This FDA Devices action (record #Z-0943-2014) was formally reported on February 19, 2014, with the manufacturer initiating the action on July 2, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Ecolab Inc is listed as the recalling firm, operating out of Saint Paul, MN. Federal records indicate 1800 individual units units are affected.

The documented reason for this recall is: Certain lots of these Bur Hole Probe Covers did not undergo endotoxin (LAL) testing to the proper levels. Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) and the countries of Austria, Germany, Finland, Ireland, France, Spain, Great Britain, Belgium, Netherlands, Switzerland, Jordan, United Kingdom, Saudi Arabia, Hungary, Latvia, M…. 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 12 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.