LIFEPAK 15 — Class II medical device recall Z-0230-2025
Ongoing recall by Physio-Control, Inc., reported 2024-11-06, distributed in CT, GA, MA, NY, OH, WA, WV. Due to an out of tolerance tool being used on monitor/defibrillator systems.
| Recall number | Z-0230-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Physio-Control, Inc., Redmond, WA, United States |
| Recall initiated | 2024-08-30 |
| Classified | 2024-10-25 |
| Reported by FDA | 2024-11-06 |
| Distributed | CT, GA, MA, NY, OH, WA, WV |
| Quantity | 105 systems |
| UPC / GTIN / UDI-DI | 00883873808214, 00883873871645, 00883873871683, 00883873871690, 00883873871706, 00883873871713, 00883873884386, 00883873911631, 00883873911648, 00883873911693, 00883873979198, 00883873979358, 00883873979426, 00883873988022 |
| Serial numbers | 38166647, 38200440, 38282988, 38290136, 38291331, 38802782, 38805564, 38805583, 39382735, 39541663, 39541666, 39752193, 40259639, 41446693, 41446867, 41446882, 41446975, 41446977, 41447020, 41447027, 41453239, 41453331, 41893891, 42324176, 42325059 and 77 more |
| Model numbers | 97577-000101, 99577-000046, 99577-000055, 99577-000061, 99577-000076, 99577-001250, 99577-001255, 99577-001256, 99577-001368, 99577-001955, 99577-001956, 99577-001957, 99577-001958, 99577-001962 |
Product
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.
Reason for recall
Due to an out of tolerance tool being used on monitor/defibrillator systems.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0230-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.