Food, drugs, devices › Covidien Llc
Device recall: LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
FDA enforcement event 89182 is a device recall by Covidien Llc of Mansfield, MA, initiated 6 Dec 2021 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 11 May 2023. Initiation: voluntary: firm initiated. Covidien Llc has 77 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Covidien Llc, Mansfield, MA.
Reason for recall
"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."
Distribution
"Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0495-2022 | LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837 | 504 devices | Class II | Terminated | 19 Jan 2022 |
Context
Other enforcement events for Covidien Llc
All 77 events for Covidien Llc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 May 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.