MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient device. When the MicroCutter XCHANGE 30 Stapler is loaded with a MicroCutter XCHANGE 30 Cartridge, two double rows of 316L stainless steel staples are delivered while simultaneously transecting tissue between the two, double

Recall Insight

This FDA Devices action (record #Z-0482-2016) was formally reported on December 30, 2015, with the manufacturer initiating the action on November 6, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Cardica, Inc. is listed as the recalling firm, operating out of Redwood City, CA. Federal records indicate 568 boxes or 6816 cartridges 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: Cardica, Inc. has received reports that use of the Blue Cartridges with the MicroCutter XCHANGE 30 Stapler was associated with incomplete firing of staples, potentially resulting in an incomplete transection or anasto… Distribution data in the federal record shows the product reached: Worldwide Distribution -- USA, distributed to the states of Alabama, California, Colorado, Florida, Georgia, Iowa, Massachusetts, Maryland, Minnesota, New York, Ohio, Pennsylvania, Rhode Island, Texas, Washington, and W…. 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.