PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2… — Class II medical device recall Z-1189-2021
Ongoing recall by Physio-Control, Inc., reported 2021-03-17, distributed nationwide. Due to complaints received regarding missing lid magnets which may result in premature battery depletion.
| Recall number | Z-1189-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Physio-Control, Inc., Redmond, WA, United States |
| Recall initiated | 2021-01-14 |
| Classified | 2021-03-09 |
| Reported by FDA | 2021-03-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CL, CR, DE, DK, ES, FI, FR, GB, HK, IE, IL, IN, IT, JO, JP, KW, LU, MT, NL, NO, NZ, PL, QA, SE, SG |
| Quantity | 89,763 units |
| Serial numbers | 092704, 158487, 293066, 344641, 366081, 45119067, 45122893, 45122948, 45122985, 45123001, 45123026, 45123059, 45123080, 45123114, 45123120, 45123132, 45123144, 45123177, 45123196, 45123211, 45123323, 45123359, 45123362, 45123381, 45123386 and 475 more |
| Model numbers | 3321605-XXX |
Product
PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any responder assistance. The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest.
Reason for recall
Due to complaints received regarding missing lid magnets which may result in premature battery depletion.
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-1189-2021. 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.