Severity
Moderate
FDA Devices recall · Reported September 10, 2025
Due to required inspections not being performed on products/units that have gone through servicing.
Physio-Control, Inc. recalled LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 88387387… - a moderate-severity action.
LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 88387387… was recalled by Physio-Control, Inc. in September 10, 2025. Reason: Due to required inspections not being performed on products/units that have gone through servicing.. Check the official notice for the remedy. Verify recall #Z-2497-2025 with the FDA Devices before acting.
The recall
Physio-Control, Inc. issued this moderate-severity FDA Devices recall-Due to required inspections not being performed on products/units that have gone through servicing..
Sourced from official FDA Devices enforcement records. Verify recall #Z-2497-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2497-2025) was formally reported on September 10, 2025, with the manufacturer initiating the action on July 22, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Physio-Control, Inc. is listed as the recalling firm, operating out of Redmond, WA. Federal records list the affected scope as 4 units.
The documented reason for this recall is: Due to required inspections not being performed on products/units that have gone through servicing. Distribution data in the federal record shows the product reached: U.S. Nationwide distribution in the states of CO and MT.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
4 units
Related Recalls
6
3 from same agency
LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
Due to required inspections not being performed on products/units that have gone through servicing.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2497-2025 |
| Date reported | September 10, 2025 |
| Date initiated | July 22, 2025 |
| Recalling firm | Physio-Control, Inc. |
| Firm location | Redmond, WA |
| Affected scope | 4 units |
| Distribution | U.S. Nationwide distribution in the states of CO and MT. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 10, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.