T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304

Recall Insight

This FDA Devices action (record #Z-2189-2015) was formally reported on July 29, 2015, with the manufacturer initiating the action on June 18, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Argon Medical Devices, Inc is listed as the recalling firm, operating out of Athens, TX. Federal records indicate 10290 units units are affected.

The documented reason for this recall is: Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. Distribution data in the federal record shows the product reached: US. 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.