CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO

Recall Insight

This FDA Devices action (record #Z-2946-2018) was formally reported on September 5, 2018, with the manufacturer initiating the action on July 30, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Civco Medical Instruments Co. Inc. is listed as the recalling firm, operating out of Kalona, IA. Federal records indicate 107 units units are affected.

The documented reason for this recall is: The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide. Distribution data in the federal record shows the product reached: United States, Austria, Belgium, Denmark, France, Germany, Poland, Spain, Switzerland and United Kingdom. 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 8 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.