Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device.

Recall Insight

This FDA Devices action (record #Z-2590-2018) was formally reported on August 8, 2018, with the manufacturer initiating the action on June 28, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Envoy Medical Corporation is listed as the recalling firm, operating out of Saint Paul, MN. Federal records indicate 4 Units units are affected.

The documented reason for this recall is: Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than the final pack and the Esteem II Sound Processors. The Sterile Wipes expired prior to the date labeled on the final pack. Distribution data in the federal record shows the product reached: US Distribution to states of: FL, OR. 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.