Device recall: ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART…

Class I FDA enforcement event 69752. Recall start date: 6 Nov 2014. Status in the FDA record: Terminated. Termination date: 30 Oct 2017.

Reason for recall, in the words of FDA

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

Class I, in the words of FDA

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

ConMed Corporation started this device recall on 6 Nov 2014. The firm address in the FDA record is in Utica, NY. FDA put the recall in Class I. FDA event 69752 has 9 product records. The first FDA enforcement report date is 10 Dec 2014. The record gives the status Terminated, with the termination date 30 Oct 2017.

FDA enforcement report The 9 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia,…

Recalling firm

ConMed Corporation, Utica, NY.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

9 product records in the event.

FDA event 69752: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0454-2015	ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.	174,610 (168,090 US and 6,520 OUS) in total.	Class I	Terminated	10 Dec 2014
Z-0455-2015	ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR	174,610 (168,090 US and 6,520 OUS) in total.	Class I	Terminated	10 Dec 2014
Z-0456-2015	ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR	174,610 (168,090 US and 6,520 OUS) in total.	Class I	Terminated	10 Dec 2014
Z-0457-2015	ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR	174,610 (168,090 US and 6,520 OUS) in total.	Class I	Terminated	10 Dec 2014
Z-0458-2015	ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR	174,610 (168,090 US and 6,520 OUS) in total.	Class I	Terminated	10 Dec 2014
Z-0459-2015	PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR	174,610 (168,090 US and 6,520 OUS) in total.	Class I	Terminated	10 Dec 2014
Z-0460-2015	MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR--Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.	174,610 (168,090 US and 6,520 OUS) in total.	Class I	Terminated	10 Dec 2014
Z-0461-2015	CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.	174,610 (168,090 US and 6,520 OUS) in total.	Class I	Terminated	10 Dec 2014
Z-0462-2015	CONMED ADULT R2 Multifunction Electrodes, REF/Catalog Number 3115-1751, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.	174,610 (168,090 US and 6,520 OUS) in total.	Class I	Terminated	10 Dec 2014

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2014: 1,176
Share of these events in Class I: 5%
Product records in this event: 9Median of the firm: 2
Events of the firm on the register: 24

Other events of the firm

Other FDA enforcement events of ConMed Corporation
Initiated	Product (first record)	Type	Class	Records
14 Jul 2026	CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor	Device	Class II	1
14 May 2026	ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units pe	Device	Class II	11
18 Nov 2022	Foot Controlled Electrosurgical Suction Coagulator, Electrosurgical Suction Coagulator 10FR, Catalog Number 130187	Device	Class II	1
26 Mar 2021	INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 a	Device	Class II	2
12 Nov 2020	Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction.	Device	Class II	2
21 Mar 2019	ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Anchor Tissue Retrieval System	Device	Class II	6
23 Feb 2018	MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use i	Device	Class II	5
19 Jun 2017	STAT 2¿ I.V. Gravity Flow Controller and STAT 2¿ Primary, Secondary Administration Sets and Extension Sets (Catalog Numb	Device	Class II	2
17 Apr 2017	Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be use	Device	Class II	1
28 Feb 2017	Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurg	Device	Class II	5

ConMed Corporation: all 24 events

Official channels

FDA enforcement report Z-0454-2015The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 69752. https://recallregister.com/fda/i/69752/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia,…
What quantity of product is in FDA event 69752?: The event has 9 product records. The first record gives this quantity: 174,610 (168,090 US and 6,520 OUS) in total.
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2014 have the same class?: 5% of the 1,176 device events that started in 2014 are in Class I.