HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818

Recall Insight

This FDA Devices action (record #Z-1701-2023) was formally reported on June 14, 2023, with the manufacturer initiating the action on April 20, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. C.R. Bard Inc is listed as the recalling firm, operating out of Covington, GA. Federal records indicate 308520 devices units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility. Distribution data in the federal record shows the product reached: Worldwide. 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 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.