Puritan Bennett Cuff Pressure Manager, REF: 180-03

Recall Insight

This FDA Devices action (record #Z-2651-2023) was formally reported on October 11, 2023, with the manufacturer initiating the action on August 22, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Covidien is listed as the recalling firm, operating out of Boulder, CO. Federal records indicate 408 units are affected.

The documented reason for this recall is: Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, which prevents the device from b… Distribution data in the federal record shows the product reached: US: AL, NJ, MA, MI, NY, NC, CO, TX, FL, KY, UT, CA, AZ, KS, IL, TN. OUS: El Salvador, Sweden, Canary Islands. 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.