Inspire Stimulation Lead Recall Issued
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 10 units of its Inspire stimulation Lead (Model 4063) due to incorrect Use By Date labeling.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 1, 2026 and geographically references United States. 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, MedicalDevices.
What Happened
Inspire Medical Systems Inc. initiated a voluntary recall of certain Inspire stimulation Leads because the 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 10 units of the Inspire Stimulation Lead, Model/Catalog Number 4063. Affected units include:
- Model 4063 (USA only lead): UDI-DI 10855728005793, Inspire part number 900-013-001; serial numbers D53393, D61104
- Model 4063 (Global lead): UDI-DI 10810098650295, Inspire part number 900-013-003; serial numbers D89539, D89540, D89543, D89559, D89563, D89564, D89577, D8959 The devices are designed to deliver stimulation to the hypoglossal nerve for treatment of obstructive sleep apnea. Distribution was nationwide in the US and to Hong Kong. Recall number Z-2516-2026. Classification: Class II.
What You Should Do
The recalling firm initiated the action via letter. Patients and healthcare providers should verify the Use By Date on affected devices and contact Inspire Medical Systems Inc. for further guidance on impacted units.
Why This Matters
The mislabeling affects a small number of implantable devices used in sleep apnea treatment and could lead to material degradation requiring additional surgery.
Source
FDA recall Z-2516-2026. https://www.fda.gov
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 (1,492 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 1, 2026.
Frequently Asked Questions
Common questions about this FDA recall.