CLASS II ONGOING Device recall · Reported 27 Dec 2023 · FDA Enforcement Report
AC Power Adapter for use with the Lifepak 15 Monitor/Defibrillator recalled
Physio-Control is recalling AC Power Adapter for use with the Lifepak 15 Monitor/Defibrillator, distributed nationwide in the US. The recall was initiated on 6 Nov 2023 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-0567-2024
- FDA event ID
- 93234
- Recalling firm
- Physio-Control, Redmond, WA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Nov 2023
- FDA classified
- 15 Dec 2023
- Reported
- 27 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Pacemakers & Defibrillators
Timeline
| 6 Nov 2023 | Recall initiated by company | |
| 15 Dec 2023 | Classified by FDA | +39 days |
| 27 Dec 2023 | 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
AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Where it was distributed
US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Why was it recalled?
AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.
Which lots are affected?
UDI-DI: 00883873940204, Adapters manufactured between 11/3/2021 - 4/24/2023
Where was it sold?
US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
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 26 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 |
Other Pacemakers & Defibrillators recalls
All 494| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DermaV Laser System recalled by Lutronic | Lutronic | Other | Nationwide |
| Device | CLASS II | Convenience kits containing select SKUs of Polycarbonate recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled | Medline Industries | Device Malfunction | Nationwide |