CLASS II ONGOING Device recall · Reported 6 Nov 2024 · FDA Enforcement Report
Lifepak 15 (lp15) recalled by Physio-Control
Physio-Control is recalling Lifepak 15 (lp15), distributed in 7 states. The recall was initiated on 30 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0230-2025
- FDA event ID
- 95373
- Recalling firm
- Physio-Control, Redmond, WA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Aug 2024
- FDA classified
- 25 Oct 2024
- Reported
- 6 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Pacemakers & Defibrillators
Timeline
| 30 Aug 2024 | Recall initiated by company | |
| 25 Oct 2024 | Classified by FDA | +56 days |
| 6 Nov 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to an out of tolerance tool being used on monitor/defibrillator systems.
Product as listed by the FDA
LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 intended use monitor/defibrillator.
Where it was distributed
U.S.: CT, GA, MA, NY, OH, WA, and WV. O.U.S.: N/A
ConnecticutGeorgiaMassachusettsNew YorkOhioWashingtonWest Virginia
Questions about this recall
Is Lifepak 15 (lp15) recalled?
Yes. Physio-Control recalled Lifepak 15 (lp15) on 30 Aug 2024. The recall is Class II and its status is Ongoing. Recall number Z-0230-2025.
Why was it recalled?
Due to an out of tolerance tool being used on monitor/defibrillator systems.
Which lots are affected?
LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 UDI-DI codes: o 00883873808214 o 00883873988022 o 00883873979426 o 00883873979358 o 00883873911693 o 00883873979198 o 00883873911648 o 00883873884386 o 00883873871713 o 00883873871706 o 00883873871690 o 00883873871683 o 00883873911631 o 00883873871645 Serial Numbers: o 45435833 o 46470647 o 46686048 o 46686573 o 46686708 o 46687360 o 46906073 o 49037777 o 49704552 o 38166647 o 38282988 o 38290136 o 38291331 o 38802782 o 39541663 o 39541666 o 39752193 o 40259639 o 41446867 o 41447020 o 41453331 o 42325059 o 43574409 o 43984215 o 45040678 o 45308104 o 45455023 o 46017745 o 46572054 o 46576300 o 48349664 o 48605645 o 48605663 o 49001744 o 49025185 o 49070762 o 49087040 o 49087053 o 49224619 o 49374174 o 49422314 o 49619921 o 38200440 o 38805564 o 38805583 o 39382735 o 41446693 o 41446882 o 41446975 o 41446977 o 41447027 o 41453239 o 41893891 o 42324176 o 42610924 o 43181935 o 43182268 o 43182389 o 43462227 o 43465372 o 43487806 o 43610792 o 43791346 o 43841374 o 43860850 o 43862247 o 43869747 o 44169862 o 44356379 o 44360003 o 44601246 o 45590467 o 45907317 o 46364496 o 46691551 o 47447195 o 47515791 o 47539203 o 47539310 o 47785570 o 47794250 o 48524850 o 48583111 o 48585709 o 48600317 o 48605407 o 48605467 o 48704914 o 48749443 o 49022830 o 49031342 o 49036187 o 49056308 o 49057928 o 49123367 o 49126651 o 49127012 o 49132399 o 49132740 o 49134638 o 49511402 o 49513814
Where was it sold?
U.S.: CT, GA, MA, NY, OH, WA, and WV. O.U.S.: N/A
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Physio-Control
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Lifepak 15, REF: 99577-000025, 99577 recalled by Physio-Control | Physio-Control | Processing Deviation | Nationwide |
| Device | CLASS II | Physio Control Infant/Child Reduced Energy Defibrillator Electrodes recalled | Physio-Control | Other | Nationwide |
| Device | CLASS II | Lifepak 1000 Part recalled by Physio-Control | Physio-Control | Processing Deviation | Nationwide |
| Device | CLASS II | Lifepak 15 Part recalled by Physio-Control | Physio-Control | Processing Deviation | Nationwide |
| Device | CLASS II | Lifepak CR2 Part recalled by Physio-Control | Physio-Control | Processing Deviation | Nationwide |
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