Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider… recallZ-0954-2011 · Covidien LP · initiated Dec 8, 2010
Terminated All recalls posted in January 2011
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 LP 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
During surgical procedures, the device may energize when clamping without pushing the activation button, which could result in unintended energy delivery to tissue.
FDA root cause category: Device Design
What the company is doing
The firm, Covidien, sent a "URGENT: PRODUCT RECALL" letter dated December 6, 2010, to the customers. The letter described the product, problem and the action to be taken by the customers. The customers were instructed to remove product from inventory, immediately quarantine the product and return any remaining stock of the lots listed to: Covidien Energy-based devices, Attention: R82, Building 4/Receiving, 5920 Longbow Drive, Boulder, CO 80301. The customers were also instructed to complete and return the Customer Response Form immediately via mail (in the envelope provided) or fax to (303) 516-8307. To return any identified product for credit or replacement, contact Customer Service at 1-800-722-8772 Option 1. Should you have any medical questions concerning this recall, please contact your local sales representative or the Covidien Clinical information Hotline at (800) 255-8522 (option 1).
Recall details
- Recall number
- Z-0954-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 8, 2010
- Posted by the FDA
- Jan 25, 2011
- Recalling firm
- Covidien LP
- Quantity
- 25,009 units
- Product code
- GEI
- FDA submissions
- K092879
- Distribution
- Worldwide distribution: USA and countries including: Australia, Canada, France, Germany, Japan, Puerto Rico, Singapore, and Uruguay.
Product description
Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien, Valleylab, a division of Tyco Healthcare Group LP, 5920 Longbow Drive, Boulder, CO 80301 Intended use: LigaSure 5 mm devices are electrosurgical instruments designed to permanently seal and divide vessels, tissue bundles, and lymphatics.
Code information (models, lots, serial numbers)
Lot No.: 188856, 190048, 190107, and 190307 through 193333 (88 lots).
Other devices under the same FDA submission
3 devices cleared under K092879 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- LigaSure LF1537Covidien LP · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES29 reports
- LigaSure LF1520Covidien LP · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES22 reports
- LigaSure LF1544Covidien LP · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES4 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 18, 2026. Text above is shown as published by the FDA.
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