BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179

Recall Insight

This FDA Devices action (record #Z-1712-2018) was formally reported on May 16, 2018, with the manufacturer initiating the action on October 19, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Datascope Corporation is listed as the recalling firm, operating out of Fairfield, NJ. Federal records indicate 1 units are affected.

The documented reason for this recall is: The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increas… Distribution data in the federal record shows the product reached: Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA.. 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.