HARMONIC HD 1000i Shears recall
HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product…
Why was HARMONIC HD 1000i Shears 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Codes: U95126 U9571N U9526Z U95A80 U9543P U95T0X U9550G GTIN: 10705036015048
- Product
- HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product…
- Recalling firm
- Ethicon Endo-Surgery Inc
- Quantity
- 7870 units
- 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 date
- September 1, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)