LigaSure recallZ-0495-2022 · Covidien Llc · initiated Dec 6, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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 [email protected] 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 [email protected]
Recall details
- Recall number
- Z-0495-2022
- Status
- Terminated
- Initiated by the company
- Dec 6, 2021
- Posted by the FDA
- Jan 13, 2022
- Recalling firm
- Covidien Llc
- Quantity
- 504 devices
- Product code
- GEI
- FDA submissions
- K162941
- Distribution
- Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution.
Product description
LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
Code information (models, lots, serial numbers)
UDI: 20884521705880 10884521705883; Lot Number: 11320187X
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LigaSure LF1837Covidien LP · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall967 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K162941 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- LigaSure LF1823Covidien LP · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES85 reports
- LigaSure LF1844Covidien LP · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES50 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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