HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal therma
Summary
The FDA issued a Class II for HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions by Ethicon Endo-Surgery Inc. Reason: An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may resu.
Details
Source
Device Recall
External ID
Z-2356-2021
Action Date
2021-09-01
Status
Ongoing
Category
device
Product Description
HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
Lot/Code Info: 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
Quantity Affected: 68960 units
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-20
Company
Blue Ash, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ethicon Endo-Surgery Inc has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ethicon Endo-Surgery Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ethicon Endo-Surgery Inc have FDA actions?
Ethicon Endo-Surgery Inc has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2356-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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