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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63015

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

Open FDA event record

Event summary

Timeline bucket
August 21, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Covidien LP

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

8 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 8

Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

Z-2432-2012
Recall number
Z-2432-2012
Initiated
August 21, 2012
Classification
Class II
Status
Terminated
Recalling firm
Covidien LP
Quantity
433,528 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

Code information

All lot numbers

Distribution pattern

Worldwide Distribution.

device · product 2 of 8

Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4535A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

Z-2433-2012
Recall number
Z-2433-2012
Initiated
August 21, 2012
Classification
Class II
Status
Terminated
Recalling firm
Covidien LP
Quantity
94,301 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.

Code information

All lot numbers

Distribution pattern

Worldwide Distribution.

device · product 3 of 8

Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET4548. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

Z-2434-2012
Recall number
Z-2434-2012
Initiated
August 21, 2012
Classification
Class II
Status
Terminated
Recalling firm
Covidien LP
Quantity
4,867 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.

Code information

All lot numbers

Distribution pattern

Worldwide Distribution.

device · product 4 of 8

Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

Z-2435-2012
Recall number
Z-2435-2012
Initiated
August 21, 2012
Classification
Class II
Status
Terminated
Recalling firm
Covidien LP
Quantity
104,355 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

Code information

All lot numbers

Distribution pattern

Worldwide Distribution.

device · product 5 of 8

Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

Z-2436-2012
Recall number
Z-2436-2012
Initiated
August 21, 2012
Classification
Class II
Status
Terminated
Recalling firm
Covidien LP
Quantity
22,218 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

Code information

All lot numbers

Distribution pattern

Worldwide Distribution.

device · product 6 of 8

Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6035A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

Z-2437-2012
Recall number
Z-2437-2012
Initiated
August 21, 2012
Classification
Class II
Status
Terminated
Recalling firm
Covidien LP
Quantity
268,022 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

Code information

All lot numbers

Distribution pattern

Worldwide Distribution.

device · product 7 of 8

Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET6048. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

Z-2438-2012
Recall number
Z-2438-2012
Initiated
August 21, 2012
Classification
Class II
Status
Terminated
Recalling firm
Covidien LP
Quantity
15,936 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

Code information

All lot numbers

Distribution pattern

Worldwide Distribution.

device · product 8 of 8

Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6048A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.

Z-2439-2012
Recall number
Z-2439-2012
Initiated
August 21, 2012
Classification
Class II
Status
Terminated
Recalling firm
Covidien LP
Quantity
135,712 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.

Code information

All lot numbers

Distribution pattern

Worldwide Distribution.

Field note

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