CLASS II ONGOING Device recall · Reported 12 Feb 2025 · FDA Enforcement Report
Lifepak 35 ECG cable recalled by Physio-Control
Physio-Control is recalling Lifepak 35 ECG cable, distributed nationwide in the US. The recall was initiated on 21 Jan 2025 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-1102-2025
- FDA event ID
- 96048
- Recalling firm
- Physio-Control, Redmond, WA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Jan 2025
- FDA classified
- 5 Feb 2025
- Reported
- 12 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 21 Jan 2025 | Recall initiated by company | |
| 5 Feb 2025 | Classified by FDA | +15 days |
| 12 Feb 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
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
LIFEPAK 35 ECG cable REF 11111-000041
Where it was distributed
U.S. Nationwide distribution in the states of CA, FL, GA, IA, IN, KY, MD, MI, MO, NE, NV, NY, OH, OR, SC, TN, TX, and WI.
Nationwide CaliforniaFloridaGeorgiaIowaIndianaKentuckyMarylandMichiganMissouriNebraskaNevadaNew YorkOhioOregonSouth CarolinaTennesseeTexasWisconsin
Questions about this recall
Why was it recalled?
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
Which lots are affected?
Catalog Number: 11111-000041 UDI-DI code: 00883873834596 Lot/Serial Number: 0224
Where was it sold?
U.S. Nationwide distribution in the states of CA, FL, GA, IA, IN, KY, MD, MI, MO, NE, NV, NY, OH, OR, SC, TN, TX, and WI.
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 Patient Monitors recalls
All 1,014| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | nGenuity Patient Monitor with Capnography recalled | Criticare Technologies | Device Malfunction | Nationwide |
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |