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ModerateClass IITerminated

FDA Devices recall · Reported April 4, 2018

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose

Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure

Recall #
Z-1174-2018
Affected scope
18,720 units in total
Initiated
February 23, 2018
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ConMed Corporation recalled MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog … - a moderate-severity action.

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog … was recalled by ConMed Corporation in April 4, 2018. Reason: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity…. Check the official notice for the remedy. Verify recall #Z-1174-2018 with the FDA Devices before acting.

The recall

ConMed Corporation issued this moderate-severity FDA Devices recall-Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity….

Moderate
severity level
19K units
affected scope
Class II
classification
April 4, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1174-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).

Reason for recall

Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-1174-2018
Date reported April 4, 2018
Date initiated February 23, 2018
Recalling firm ConMed Corporation
Firm location Utica, NY
Affected scope 18,720 units in total
Distribution Worldwide Distribution: US (Nationwide) and countries of: New Zealand, Saudi Arabia, Switzerland, United Arab Emirates Uruguay & Republic of Macedonia (The former Yugoslav Republic of Macedonia).

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

18,720 units in total units affected - limited or regional distribution scale.

Regional (<10K units) -
Multi-state (10K – 100K units) ✓ This recall
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-1174-2018) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (non-invasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric infants whose weight is less than 10 kg. (22 lbs.).. Recalled by ConMed Corporation. Units affected: 18,720 units in total.
Why was this product recalled?
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Which agency issued this recall?
This recall was issued by the FDA Devices on April 4, 2018. Severity: Moderate. Recall number: Z-1174-2018.
Where was the recalled product distributed?
Distribution: Worldwide Distribution: US (Nationwide) and countries of: New Zealand, Saudi Arabia, Switzerland, United Arab Emirates Uruguay & Republic of Macedonia (The former Yugoslav Republic of Macedonia)..
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported April 4, 2018. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026