Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. They are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field. Radio

Recall Insight

This FDA Devices action (record #Z-2795-2015) was formally reported on September 30, 2015, with the manufacturer initiating the action on August 18, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Brainlab AG is listed as the recalling firm, operating out of Feldkirchen, N/A. Federal records indicate For 28 US consignees, 9,900 Disposable reflective marker spheres ***For 451 non-US consignees, 359,280 Disposable reflective marker spheres units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS spheres may separate at the mid-point where the two halves of the sphere are sealed together. Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) including states of: TX, CA, TN, NY, LA, IL, MA, PA, OH, AZ, ID, CT, MI, and KY; and countries of: Algeria, Argentina, Australia, Bahrain, Belarus, Bolivia, Brazil, Chile, China, …. 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 11 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.