Reported May 1, 2024 · Ongoing
20" Lead Wires, Replacement Part Number: 1067724-2
Ebi, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: EBI, LLC · 1 Gatehall Dr Ste 303 · Parsippany, NJ · 07054-4514
Is this the product you have?
- 20" Lead Wires
- Replacement Part Number1067724-2
- Lot codes and dates
- UDI-DI00812301020300 All devices distributed since May 1, 2023
- Amount recalled
- 829 units (2 lead wires assembly)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Ebi, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.