Recall of Force TriVerse Electrosurgical Kits Due to Sterility Concerns
Covidien is recalling Force TriVerse Electrosurgical Kits distributed in EMEA due to potential sterile packaging compromise, which may increase infection risk.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (infection risk) where injury has not yet been reported, fitting the 'High' severity criteria for medical devices with potential but unconfirmed harm.
Plain-English summary
Covidien LLC is recalling kits containing Force TriVerse Electrosurgical Devices. These kits are manufactured in The Netherlands and were distributed exclusively in the EMEA region (Europe, Middle East, and Africa). There is no U.S. distribution of these kits.
The recall was initiated because the sterile packaging may potentially be compromised. The use of these products may result in an increased risk for infection. Specific lot numbers are listed in the official recall documentation.
Healthcare providers and facilities in the EMEA region should stop using these kits and contact the manufacturer for further instructions. Consumers in the United States are not affected by this recall.
The recalled product
- Product
- Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distribution. Kits are manufactured in The Netherlands. Item codes BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01…
- Manufacturer
- Covidien Llc
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Covidien Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Covidien Llc
See all →- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- ModerateCovidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
- ModerateCovidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateShiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
Same hazard · infection
See all →- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
Similar recalls
- HighFDA Recalls 850 Units of Covidien Force TriVerse Electrosurgical Devices
FDA (Devices) · 2019-03-27
- SevereMahurkar Elite Acute Triple Lumen Catheter Tray Recalled for Sterility Concerns
FDA (Devices) · 2015-09-09
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- SeverePhilips HEARTSTART Electrode Pads Recalled for Incompatibility with AEDs
FDA (Devices) · 2014-10-22
- SevereMediTrace Cadence Defibrillation Electrodes Recalled for Wire Insulation Damage
FDA (Devices) · 2015-09-09
- HighMedline Convenience Kits Recalled Due to Potential Sterility Assurance Issues
FDA (Devices) · 2026-02-25