Use cautionMedical device recall · FDA · Published July 20, 2021
Ethicon HARMONICHD 1000i Shears Recall: Risk of Continuous Activation and Burns
Ethicon recalls HARMONICHD 1000i Shears (36cm shaft) due to potential internal component cracking causing continuous activation and burns. Affected units have specific product codes and lot numbers.
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
Take action
Contact the company
📍Recalling firmEthicon Endo-Surgery Inc4545 Creek Rd · Blue Ash, OH 45242-2803
“Ethicon HARMONICHD 1000i Shears Recall: Risk of Continuous Activation and Burns.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62188-ethicon-harmonichd-1000i-shears-recall-risk-of-continuous-activation-and. Based on FDA recall #Z-2356-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2356-2021%22&limit=1).
Ethicon Endo-Surgery Inc, with FDA assistance, recalled HARMONICHD 1000i Shears on July 20, 2021, due to a cracked internal component that may cause burns. The Food and Drug Administration announced the Class II recall of 68,960 units distributed worldwide.
An internal component may be cracked and become lodged behind the energy button, potentially resulting in continuous activation of the device. This malfunction may result in burns to patients.
Context
GovInfoNow's records show Ethicon Endo-Surgery Inc has 12 other recalls on record since October 23, 2017. Recent similar recalls include an ECHELON LINEAR Cutters Reload recall on September 11, 2025, and an Endopath Echelon Vascular White Reload recall on April 22, 2025. Other recent recalls of similar products include a TD Navio Maxi Speech Device Recall (July 8, 2026), a TD Navio Midi Speech Device Recall (July 8, 2026), and an Integra Cytal Burn Matrix 7x10 cm recall (March 19, 2026).
How to tell if you have this one
Check for product codes starting with HARHD36 and lot numbers like U94Y9V, U95C2A, or others listed in the recall notice. The shears are intended for soft tissue incisions when bleeding control and minimal thermal injury are desired.
Brand
Ethicon
Product
HARMONICHD 1000i Shears (36cm Shaft Length)
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
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.
Recall number
Product, codes & lots
Quantity
Z-2355-2021
HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20; Lot Codes: U95126 U9571N U9526Z U95A80 U9543P U95T0X U9550G GTIN: 10705036015048
Identify the product code and lot number on the shears to confirm if they are affected by this recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2356-2021 (July 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2356-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.