Manual bunnell cranial drills are bone cutting and drilling instruments that are used without a power source on a patient's skull sold under the Boss Instruments brand name.

Recall Insight

This FDA Devices action (record #Z-0537-2015) was formally reported on December 17, 2014, with the manufacturer initiating the action on September 8, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Instrumed International, Inc. is listed as the recalling firm, operating out of Schaumburg, IL. Federal records indicate 13 drills units are affected.

The documented reason for this recall is: The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devic… Distribution data in the federal record shows the product reached: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.. 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.