Physio-Control recalls LIFEPAK 35 ECG cable REF 11111-000041 due to missing cleaning instructions in user manual. Affected units shipped with incorrect instructions.
“Physio-Control LIFEPAK 35 ECG Cable Recall: Missing Cleaning Instructions.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53056-physio-control-lifepak-35-ecg-cable-recall-missing-cleaning-instructions. Based on FDA recall #Z-1102-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1102-2025%22&limit=1).
Physio-Control, Inc. recalled LIFEPAK 35 ECG cables due to incorrect instruction manuals lacking proper cleaning and disinfection guidance, the FDA said on Jan. 21, 2025.
How to tell if you have it
Brand: Physio-Control
Product: LIFEPAK 35 ECG cable
REF: 11111-000041
Catalog Number: 11111-000041
UDI-DI code: 00883873834596
Lot/Serial Number: 0224
Units affected: 245
The hazard
The product was shipped with incorrect instructions for use (IFU) that do not include proper cleaning and disinfection instructions.
Context
GovInfoNow's records show Physio-Control, Inc. has 17 other recalls on record since Oct. 27, 2017. Other recent recalls of similar products include Medline Medical Procedure Kits Recall: Catheter Issues May Cause Disconnection (May 4, 2026) and Medline Convenience Kits Recall: Contaminated Components Risk (July 10, 2026).
How to tell if you have this one
Check for the model number REF 11111-000041 on the cable. Affected units have the UDI-DI code 00883873834596 and lot/serial number 0224.
Brand
Physio-Control
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check User Manual
Verify if the user manual includes cleaning and disinfection instructions for the LIFEPAK 35 ECG cable.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 18 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Georgia, Indiana, Iowa, Kentucky, Maryland, Michigan, Missouri, Nebraska, Nevada, New York, Ohio, Oregon, South Carolina, Tennessee, Texas, Wisconsin.
Recall timeline
FDA published this recall 22 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1102-2025 (January 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1102-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.