Severity
Moderate
FDA Devices recall · Reported March 11, 2020
Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
Covidien Llc recalled Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Eur… - a moderate-severity action.
Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Eur… was recalled by Covidien Llc in March 11, 2020. Reason: Sterile packaging may potentially be compromised, and use of products may result in increased risk for infect…. Check the official notice for the remedy. Verify recall #Z-1447-2020 with the FDA Devices before acting.
The recall
Covidien Llc issued this moderate-severity FDA Devices recall-Sterile packaging may potentially be compromised, and use of products may result in increased risk for infect….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1447-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1447-2020) was formally reported on March 11, 2020, with the manufacturer initiating the action on February 10, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Covidien Llc is listed as the recalling firm, operating out of Mansfield, MA. Federal records list the affected scope as N/A.
The documented reason for this recall is: Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection. Distribution data in the federal record shows the product reached: Nationwide domestic distribution. Foreign distribution to Australia, Canada, Austria Belgium Canary Islands Czech Republic Denmark Finland France Germany Greece Hungary Italy Jordan Kazakhstan Kenya Lithua…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
N/A
Related Recalls
6
3 from same agency
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 BREASTKIT01 BREASTKIT01 BREASTKIT02 LAR28PLN MGBGLOCX1 SGGLOCX1 HEMICX1 LAPWL STOM25PL TGGLOCX1 TIROIDEKIT UROCYSPL VAGHCJ VATSZD2 VGYN VMED VMED3 ZGVATS1
Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1447-2020 |
| Date reported | March 11, 2020 |
| Date initiated | February 10, 2020 |
| Recalling firm | Covidien Llc |
| Firm location | Mansfield, MA |
| Affected scope | N/A |
| Distribution | Nationwide domestic distribution. Foreign distribution to Australia, Canada, Austria Belgium Canary Islands Czech Republic Denmark Finland France Germany Greece Hungary Italy Jordan Kazakhstan Kenya Lithuania Luxembourg Nor… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 11, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.