FDA Medical Device Recalls (openFDA)
Covidien Llc: LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
- Recall number
- Z-0495-2022
- Recalling firm
- Covidien Llc
- Product
- LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
- Status
- Terminated
- Initiated
- 2021-12-06
- Posted
- 2022-01-13
- Terminated
- 2023-05-11
- Reason
- Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or loss, and delay in treatment while an alternate device is obtained.
- Root cause
- Device Design
- Action
- URGENT MEDICAL DEVICE RECALL notification letters dated 12/2021 were sent to customers. Customer Action Required: 1. Please immediately quarantine and discontinue use of the affected item code with the associated lot number listed above. 2. Please return affected product as indicated below. All products from the affected item code and associated lot number must be returned. 3. If you have distributed the product item code and lot number listed above, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory and email it to rs.anzrecalls@medtronic.com We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please do not hesitate to contact Azi Hosseini on +61 428 464 838, or azi.hosseini@medtronic.com
- Quantity
- 504 devices
- Distribution
- Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution.
- Lot, serial or model codes
- UDI: 20884521705880 10884521705883; Lot Number: 11320187X
- 510(k) numbers
- ["K162941"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28