Food, drugs, devices › Physio-Control, Inc.
Device recall: LIFEPAK 35 ECG cable REF 11111-000041
Physio-Control, Inc. (Redmond, WA) initiated this device recall on 21 Jan 2025; FDA lists 1 product record under event 96048, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Physio-Control, Inc. has 27 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Physio-Control, Inc., Redmond, WA.
Reason for recall
"Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions"
Distribution
"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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1102-2025 | LIFEPAK 35 ECG cable REF 11111-000041 | 245 units | Class II | Ongoing | 12 Feb 2025 |
Context
Other enforcement events for Physio-Control, Inc.
All 27 events for Physio-Control, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.