Physio-Control Defibrillators May Lack Required Performance Inspection
Physio-Control defibrillators (LIFEPAK 15, 1000, 35, and 20e models) serviced between July 2023 and November 2025 may not have undergone required Performance Inspection Procedures, potentially preventing therapy delivery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II device recall (FDA classification) involving defibrillators with potential inability to perform their critical function. Although no illnesses or injuries are reported, the hazard—failure to deliver life-saving therapy—poses significant risk of harm to patients who depend on these devices in emergency settings.
Plain-English summary
Physio-Control, Inc. is recalling certain defibrillators that were serviced between July 2023 through November 2025. These devices were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted as required.
The affected models include LIFEPAK 15, LIFEPAK 1000, LIFEPAK 35, and LIFEPAK 20e, with specific reference numbers and serial numbers identified in the recall. A total of 206 units are affected and were distributed nationwide to the states of Michigan, Washington, Kentucky, Indiana, Florida, North Carolina, Texas, Louisiana, Virginia, New York, Massachusetts, Colorado, Pennsylvania, Ohio, South Carolina, Oklahoma, Minnesota, West Virginia, New Jersey, and Wisconsin.
When a Performance Inspection Procedure is not properly conducted, the device may not function as intended. This failure could result in delays or inability to provide defibrillation therapy to patients who depend on these devices in emergency situations.
Customers who have these devices should contact Physio-Control, Inc. to verify whether their device underwent the required inspection procedure and obtain appropriate service or replacement if needed.
The recalled product
- Product
- 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…
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
- Affected units
- 206
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Device/UDI/Serial Number: LIFEPAK 15/0088387391164815011543166573
- 0088387387169015033143394891
- 0088387387169015050743524360
- 0088387387169015092843914574
- 0088387387204815093043915122
- 0088387387169016010444187447
- 0088387387162116012044252611
- 0088387387169016012644262721
- 0088387387169016012644277082
- 0088387387169016012744282280
- 0088387387171316060244574340
- 0088387387171316080444896329
- 0088387387169016083144962804
- 0088387387170617013145447229
- 0088387387169017041245743786
- 0088387387171317050945834209
- 0088387387171317062845998142
- 0088387387171317082846103043
- 0088387387169017101046303288
- 0088387387171317103146303092
Distribution
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