CLASS II ONGOING Device recall · Reported 1 Sep 2021 · FDA Enforcement Report

Harmonichd 1000i Shears Shaft Length)-indicated recalled

Ethicon Endo-Surgery is recalling Harmonichd 1000i Shears Shaft Length)-indicated for soft tissue incisions when bleeding, distributed nationwide in the US. The recall was initiated on 20 Jul 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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 GTIN: 10705036015055

Quantity recalled68960 units

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-2356-2021
FDA event ID: 88434
Recalling firm: Ethicon Endo-Surgery, Blue Ash, OH
Classification: Class II
Status: Ongoing
Recall initiated: 20 Jul 2021
FDA classified: 26 Aug 2021
Reported: 1 Sep 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

20 Jul 2021	Recall initiated by company
26 Aug 2021	Classified by FDA	+37 days
1 Sep 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36

Where it was distributed

Worldwide distribution - US Nationwide distribution and the countries of Austria, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United Arab Emirates.

Nationwide Puerto Rico

Questions about this recall

Is Harmonichd 1000i Shears Shaft Length)-indicated for soft tissue incisions when bleeding recalled?

Yes. Ethicon Endo-Surgery recalled Harmonichd 1000i Shears Shaft Length)-indicated for soft tissue incisions when bleeding on 20 Jul 2021. The recall is Class II and its status is Ongoing. Recall number Z-2356-2021.

Why was it 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

Which lots are affected?

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 GTIN: 10705036015055

Where was it sold?

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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