Reported Sep 1, 2021 · Ongoing
HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal…
Ethicon Endo-Surgery Inc.
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: Ethicon Endo-Surgery Inc · 4545 Creek Rd · Blue Ash, OH · 45242-2803
Is this the product you have?
- HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired
- Product CodeHARHD20
- Lot codes and dates
- Lot CodesU95126 U9571N
- U9526Z U95A80 U9543P U95T0X U9550G GTIN10705036015048
- Amount recalled
- 7870 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns
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.
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