ConMed Adult Radiotransparent Electrodes Recalled for Connection Design Changes
ConMed is recalling 174,610 Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states that the failure to connect could result in patient death or serious injury, which meets the criteria for a Critical severity score.
Plain-English summary
ConMed Corporation is recalling 174,610 units of Adult Radiotransparent Electrodes (REF/Catalog Number 2001H-PC). The recall affects all lot codes and includes 168,090 units distributed in the US and 6,520 units distributed outside the US.
The recall is due to design changes made by Philips Healthcare to the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. These changes may result in a failure to connect, which could delay therapy and potentially lead to patient death or serious injury.
The affected products were distributed worldwide, including nationwide in the US, Puerto Rico, and internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain. Users should stop using these electrodes and contact ConMed Corporation for further instructions.
The recalled product
- Product
- ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
- Manufacturer
- ConMed Corporation
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
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 →Related recalls
Same manufacturer · ConMed Corporation
See all →- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- HighConMed AirSeal 8mm 100mm optical obturator ports may trigger overpressure alerts
FDA (Devices) · 2026-06-24
- HighConMed AirSeal 12mm bladeless optical obturators may trigger overpressure alerts
FDA (Devices) · 2026-06-24
- HighConMed AirSeal 5mm 100mm optical obturator ports may trigger overpressure alerts
FDA (Devices) · 2026-06-24
- HighConMed AirSeal 12mm blunt tip 100mm ports may trigger overpressure alerts
FDA (Devices) · 2026-06-24
Same hazard · device malfunction
See all →- HighPhilips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
FDA (Devices) · 2026-09-02
- HighBD Needle Kit for Powered Driver Recall Due to Removal Difficulty
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighIntegrated Medcraft Recalls First Aid Kits with Defective Airway Tips
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12