CLASS II ONGOING Device recall · Reported 1 May 2024 · FDA Enforcement Report
48" Lead Wires, Replacement recalled by EBI
EBI is recalling 48" Lead Wires, Replacement, distributed nationwide in the US. The recall was initiated on 22 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1619-2024
- FDA event ID
- 94291
- Recalling firm
- EBI, Parsippany, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Mar 2024
- FDA classified
- 23 Apr 2024
- Reported
- 1 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 22 Mar 2024 | Recall initiated by company | |
| 23 Apr 2024 | Classified by FDA | +32 days |
| 1 May 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
48" Lead Wires, Replacement Part Number: 1067724-4
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is 48" Lead Wires, Replacement recalled?
Yes. EBI recalled 48" Lead Wires, Replacement on 22 Mar 2024. The recall is Class II and its status is Ongoing. Recall number Z-1619-2024.
Why was it recalled?
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Which lots are affected?
UDI-DI: 00812301020324 All devices distributed since May 1, 2023
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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