Composix" LP with Echo PS" 6x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Recall Insight

This FDA Devices action (record #Z-1684-2014) was formally reported on June 11, 2014, with the manufacturer initiating the action on April 24, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Davol, Inc., Subs. C. R. Bard, Inc. is listed as the recalling firm, operating out of Warwick, RI. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.

The documented reason for this recall is: Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH A…. 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 12 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.