Physio-Control LIFEPAK Defibrillators Recall
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Physio-Control, Inc. is recalling 206 LIFEPAK defibrillators serviced between July 2023 and November 2025 without documented Performance Inspection Procedure.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on May 26, 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, medical-devices.
What Happened
Physio-Control, Inc. initiated a voluntary recall of certain LIFEPAK defibrillators after determining that units serviced between July 2023 through November 2025 lacked objective evidence that a Performance Inspection Procedure (PIP) was conducted. The inability to perform the device's intended use may result in delays or inability to provide therapy.
Which Products Are Affected
The recall covers 206 units distributed nationwide in the states of MI, WA, KY, IN, FL, NC, TX, LA, VA, NY, MA, CO, PA, OH, SC, OK, MN, WV, NJ, and WI. Affected models include:
- LIFEPAK 15 (REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045)
- LIFEPAK 1000 (REF: 99425-000025, 99425-000023, 99425-000096)
- LIFEPAK 35 (REF: 99335-000013, 99335-000031)
- LIFEPAK 20e (REF: 99507-000122)
Specific serial numbers and UDI information are listed in FDA recall Z-2065-2026.
What You Should Do
The recalling firm, Physio-Control, Inc., located at 11811 Willows Rd Ne, Redmond, WA 98052-2003, should be contacted regarding affected devices.
Why This Matters
Class II recall affects devices that may cause temporary or reversible adverse health consequences if the defibrillator cannot deliver therapy as intended.
Source
FDA recall number Z-2065-2026, report date 20260513.
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 (1,515 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to May 26, 2026.
Frequently Asked Questions
Common questions about this FDA recall.