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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85689

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

Open FDA event record

Event summary

Timeline bucket
May 12, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

4 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 4

Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

Z-2252-2020
Recall number
Z-2252-2020
Initiated
May 12, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Covidien Llc
Quantity
12,610 total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing assembly error

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

The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.

Code information

Lots P9J0241Y P9J0242Y P9J0243Y P9K1140Y P9K1663Y P9K1141Y

Distribution pattern

Worldwide distribution.

device · product 2 of 4

Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

Z-2253-2020
Recall number
Z-2253-2020
Initiated
May 12, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Covidien Llc
Quantity
12,610 total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing assembly error

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

The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.

Code information

Lots P9J1172Y P9K0452Y P9K0453Y P9K0454Y P9K1596Y P0B0996Y

Distribution pattern

Worldwide distribution.

device · product 3 of 4

Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

Z-2254-2020
Recall number
Z-2254-2020
Initiated
May 12, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Covidien Llc
Quantity
12,610 total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing assembly error

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

The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.

Code information

Lots P9J1171Y P9K1395Y P9K1582Y

Distribution pattern

Worldwide distribution.

device · product 4 of 4

Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

Z-2255-2020
Recall number
Z-2255-2020
Initiated
May 12, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Covidien Llc
Quantity
12,610 total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing assembly error

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

The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.

Code information

Lots P9J0368Y P9J0369Y P9J0517Y P9K1300Y

Distribution pattern

Worldwide distribution.