Agency classClass IOur severity:Critical FDA (Devices)·Z-0455-2015·Announced 2014-12-10

ConMed Adult Radiotransparent Electrode Recall Due to Connection Design Changes

ConMed is recalling Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause connection failures, potentially delaying therapy and resulting in patient death or serious injury.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states that the defect 'could result in patient death or serious injury,' which meets the rubric criteria for a Critical severity score (5).

Plain-English summary

ConMed Corporation is recalling 174,610 units of Adult Radiotransparent Electrodes (REF/Catalog Number 2001H-C). These electrodes are comparable to Philips Medical HeartStart electrodes with plug-style connectors. The recall covers units distributed nationwide in the United States, Puerto Rico, and internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.

The recall is being conducted because Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The source text states that a failure to connect may result in a delay of therapy, which could result in patient death or serious injury.

Healthcare facilities and users should stop using the affected electrodes and contact ConMed Corporation for further instructions on the recall process.

The recalled product

Product: ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
Manufacturer: ConMed Corporation
Category: Medical Device — Defibrillator Electrodes
Hazard: connection-failure
delayed-therapy
death
serious-injury

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All Lot Codes

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 9 recalled by ConMed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Same manufacturer · ConMed Corporation

See all →

Moderate
ConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
High
ConMed AirSeal 12mm blunt tip 100mm ports may trigger overpressure alerts
FDA (Devices) · 2026-06-24
High
ConMed AirSeal 12mm bladeless optical obturators may trigger overpressure alerts
FDA (Devices) · 2026-06-24
High
ConMed AirSeal 5mm 100mm optical obturator ports may trigger overpressure alerts
FDA (Devices) · 2026-06-24
High
ConMed AirSeal 8mm 100mm optical obturator ports may trigger overpressure alerts
FDA (Devices) · 2026-06-24

Same hazard · connection failure