injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle cannula is 25 gauge

Recall Insight

This FDA Devices action (record #Z-1478-2023) was formally reported on May 10, 2023, with the manufacturer initiating the action on February 7, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Labories Medical Technologies is listed as the recalling firm, operating out of Portsmouth, NH. Federal records list the affected scope as 415,480 units, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: The packaging may be damaged, compromising the sterile barrier. Distribution data in the federal record shows the product reached: Worldwide distribution.. 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 and NHTSA 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 3 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.