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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84991

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 10, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Covidien Llc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934

Z-1446-2020
Recall number
Z-1446-2020
Initiated
February 10, 2020
Classification
Class II
Status
Terminated
Recalling firm
Covidien Llc
Quantity
70361

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterile packaging may potentially be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.

Code information

Lots 181170378R 181170379R 181170380R 192100010R 192170108R 192170109R 192240106R 192240107R 192240108R 192630089R 192100011R 192660102R 192450230R 192660103R 192800040R 190530412R 190530413R 190600130R 190630011R 190640010R 190880338R 190880339R 190880340R 190880341R 191020334R 191160340R 191160342R 191300316R 191300317R 191370322R 191370323R 191510192R 191440287R 191510193R 191580245R 191580246R 191580247R 191650218R 191650219R 191720261R 191790222R 191790223R 191790224R 191860195R 191860197R 191090309R 191090310R 191440286R 191930105R 191930107R 191930108R 192170106R 192170107R 191720259R 192000197R 192000200R 192070039R 192100007R 192070038R 191160341R 191650217R 191860198R 191930106R 192000198R 192000199R 192520130R 192660097R 192660099R 192660100R 192070041R 192520129R 192380040R 192450224R 192450225R 192450227R 192520131R 192380041R 192600113R 192730131R 192870153R

Distribution pattern

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 North Macedonia Poland Portugal Reunion Romania Russian Federation Serbia Slovakia Spain Sweden Switzerland United Kingdom No U.S. distribution of Kits. Foreign distribution in EMEA only. (Europe, Middle East and Africa.)

device · product 2 of 2

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

Z-1447-2020
Recall number
Z-1447-2020
Initiated
February 10, 2020
Classification
Class II
Status
Terminated
Recalling firm
Covidien Llc
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Sterile packaging may potentially be compromised

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.

Code information

Lots 0218917589 0218909457 0218940986 0219010003 0218954164 0218909455 0218938181 0219010001 0219015316 0218909452 0218953902 0219010002 0218862144 0218909456 0218953120 0219010000 0218909458 0218909460 0218917904 0219010004 0218909454 0218917602 0218962165 0219010005 0218909453 0218917603 0219013846 0219009999 0218909459 0218917588 0219013847 0218907363 0218953822 0218908405 0218953514 0218813863 0218782098 0218836471 0218836472 0218836473 0218836474 0218836470 0218863976 0218836468 0218836475 0218851370 0218836469 0218879245 0218836478 0218861244 0218927160 0218926415 0218907609

Distribution pattern

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 North Macedonia Poland Portugal Reunion Romania Russian Federation Serbia Slovakia Spain Sweden Switzerland United Kingdom No U.S. distribution of Kits. Foreign distribution in EMEA only. (Europe, Middle East and Africa.)