Inspire Respiratory Sensing Lead Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Inspire Medical Systems Inc. is recalling 50 units of the Inspire Respiratory Sensing Lead (Model 4340) due to incorrect Use By Date labeling extending beyond validated shelf life.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 2, 2026 and geographically references United States and Hong Kong. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Inspire Medical Systems Inc. initiated a voluntary recall of the Inspire Respiratory Sensing Lead (Model 4340) because products are labeled with an incorrect Use By Date that extends beyond the validated three-year shelf life from the date of manufacture. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.
Which Products Are Affected
The recall affects 50 impacted units of the Inspire Respiratory Sensing Lead, Model/Catalog Number 4340. Affected units include specific serial numbers for the USA only lead (UDI-DI 10855728005946, Inspire part number 900-014-003) and Global lead (UDI-DI 10810098650301, Inspire part number 900-014-005). Distribution was worldwide, including US Nationwide and Hong Kong. Recall number: Z-2515-2026. Recall initiation date: May 11, 2026. Classification: Class II.
What You Should Do
Consumers with affected devices should contact the recalling firm for further instructions regarding the labeled Use By Date issue.
Why This Matters
The incorrect labeling affects 50 units distributed in the US and Hong Kong, with potential for material degradation leading to revision surgery.
Source
FDA recall Z-2515-2026, Inspire Medical Systems Inc., Golden Valley, MN.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,284 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.