Reported Sep 1, 2021 · Ongoing

HARMONICHD 1000i Shears (36cm 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?

  • HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired
  • Product CodeHARHD36
Lot codes and dates
  • Lot Codes
    • U94Y9V
    • U95C2A
    • U94Z98
    • U95427
    • U9516E
    • U95599
    • U9503G
    • U95856
    • U94Y9W
    • U95L0A
    • U9518D
    • U95526
    • U9507E
    • U9548R
    • U95127
    • U95525
    • U9530P
    • U95T2Z
    • U95366
    • U95R4F
    • U9521Z
    • U95F2T
    • U9554U
    • U95F8W
    • U9564G
    • U95U6A
    • U95524
    • U95E6F
    • U9512D
    • U95K4D
    • U94Z49
    • U95F07
    • U95A9X
    • U95F6N
    • U9569W
    • U95E1U
    • U9571P
    • U95E72
    • U9587D
    • U95E29
    • U95815
    • U95T90
    • U95814
    • U95Z67
    • U95754
    • U95Y7G
  • U95D4T U9523L U95566 U9530X U9543R GTIN10705036015055
Amount recalled
68960 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:40 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.