Severity
Moderate
ConMed Corporation issued this FDA Devices recall on April 4, 2018. Classified as Moderate severity (Class II). Approximately 18,720 units in total units are affected. The recall was issued because: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
This FDA Devices action (record #Z-1178-2018) was formally reported on April 4, 2018, with the manufacturer initiating the action on February 23, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. ConMed Corporation is listed as the recalling firm, operating out of Utica, NY. Federal records indicate 18,720 units in total units are affected.
The documented reason for this recall is: Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure Distribution data in the federal record shows the product reached: 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).. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 8 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Severity
Moderate
Units Affected
18,720 units in total
Related Recalls
6
6 from same agency
MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z 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.).
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1178-2018 |
| Date reported | April 4, 2018 |
| Date initiated | February 23, 2018 |
| Recalling firm | ConMed Corporation |
| Units affected | 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.
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Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
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Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).