Exact FDA event identifier

Event 86214

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

Event summary

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

9 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 9

Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Z-0001-2021

Recall number: Z-0001-2021
Initiated: August 12, 2020
Classification: Class II
Status: Ongoing
Recalling firm: Covidien, LP
Quantity: 900,007 total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

assembly error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Code information

Lot Numbers: T0A108X T7H003X T8D008X T8K108X T9G060X T0E051X T7L023X T8H047X T8M079X T7G003X T8D007X T8K047X T9F132X

Distribution pattern

Worldwide distribution - US Nationwide and Global Distribution.

device · product 2 of 9

Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Z-0002-2021

Recall number: Z-0002-2021
Initiated: August 12, 2020
Classification: Class II
Status: Ongoing
Recalling firm: Covidien, LP
Quantity: 900,007 total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

assembly error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Code information

Lot Numbers: T0A016X T8D009X T8E058X T8H024X T9D052X T0B130X T8D010X T8E069X T8H025X T9D149X T0D070X T8D012X T8H004X T8H061X T9E081X T7H001X T8D013X T8H008X T8M044X T9E082X T7L024X T8D041X T8H009X T9A032X T9F133X T7L025X T8D042X T8H010X T9A033X T9G029X T8B012X T8D043X T8H011X T9A082X T9G037X T8B013X T8D044X T8H012X T9B039X T9G085X T8C026X T8D045X T8H013X T9B040X T9G086X T8C027X T8D046X T8H014X T9D043X T9G093X T8C045X T8E049X T8H022X T9D050X T9K069X T8C046X T8E050X T8H023X T9D051X T9M069X T8C047X T8E057X

Distribution pattern

Worldwide distribution - US Nationwide and Global Distribution.

device · product 3 of 9

Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Z-0003-2021

Recall number: Z-0003-2021
Initiated: August 12, 2020
Classification: Class II
Status: Ongoing
Recalling firm: Covidien, LP
Quantity: 900,007 total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

assembly error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Code information

Lot Numbers: T0C085X T8B048X T8K049X T8L087X T9J072X T7H002X T8B049X T8K095X T9G027X T9J099X T7L026X T8E063X T8L084X T9H043X T9L073X T7L027X T8E064X T8L085X T9H115X T9M016X T8B014X T8E075X T8L086X T9H116X T9M111X T8B015X T8F074X

Distribution pattern

Worldwide distribution - US Nationwide and Global Distribution.

device · product 4 of 9

Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Z-0004-2021

Recall number: Z-0004-2021
Initiated: August 12, 2020
Classification: Class II
Status: Ongoing
Recalling firm: Covidien, LP
Quantity: 900,007 total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

assembly error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Code information

Lot Numbers: T7F017X T7J023X T7L032X T7L034X T8L100X T7F025X T7J024X T7L033X T7L035X T9F138X T7F026X T7K020X

Distribution pattern

Worldwide distribution - US Nationwide and Global Distribution.

device · product 5 of 9

Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Z-0005-2021

Recall number: Z-0005-2021
Initiated: August 12, 2020
Classification: Class II
Status: Ongoing
Recalling firm: Covidien, LP
Quantity: 900,007 total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

assembly error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Code information

Lot Numbers: T0A018X T8B045X T8E051X T8L052X T9E050X T0A106X T8B046X T8E052X T8L101X T9F024X T0B131X T8B047X T8E065X T8L131X T9F037X T0D138X T8C025X T8E066X T8L132X T9F040X T0E011X T8C030X T8H015X T8L143X T9F044X T7G001X T8C031X T8H016X T8M080X T9F045X T7H004X T8C043X T8H017X T8M092X T9F046X T7H007X T8D001X T8H018X T8M093X T9F097X T7J025X T8D002X T8H049X T8M094X T9G031X T7K018X T8D003X T8J012X T9A006X T9G124X T7K034X T8D004X T8J026X T9A034X T9G125X T7L022X T8D005X T8J039X T9A035X T9H041X T7L036X T8D006X T8J040X T9A118X T9H102X T7L037X T8D014X T8K006X T9B060X T9H110X T8A058X T8D015X T8K008X T9C023X T9J071X T8A059X T8D047X T8L012X T9C024X T9J114X T8A062X T8D048X T8L013X T9C058X T9K077X T8A063X T8D049X T8L014X T9C059X T9L021X T8A064X T8D050X T8L015X T9D053X T9L037X T8A065X T8D051X T8L016X T9D099X T9M017X T8B001X T8D052X T8L049X T9D124X T9M018X T8B002X T8D053X T8L050X T9D125X T9C060X T8B044X T8D054X

Distribution pattern

Worldwide distribution - US Nationwide and Global Distribution.

device · product 6 of 9

Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Z-0006-2021

Recall number: Z-0006-2021
Initiated: August 12, 2020
Classification: Class II
Status: Ongoing
Recalling firm: Covidien, LP
Quantity: 900,007 total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

assembly error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Code information

Lot Numbers: T0A019X T7K037X T8H021X T8L102X T9E097X T0A105X T7K038X T8H050X T8L103X T9E098X T0A117X T7K039X T8J044X T8M010X T9F025X T0A141X T7K040X T8J045X T9A037X T9F047X T0B132X T7K041X T8J060X T9A128X T9F048X T0C045X T7L040X T8K044X T9B002X T9F098X T0C102X T7L041X T8K045X T9B003X T9H112X T0C128X T8B042X T8K046X T9C065X T9H146X T0D057X T8B043X T8K052X T9C066X T9K003X T0D120X T8C032X T8K075X T9C111X T9L039X T7G002X T8C033X T8K076X T9C145X T9M029X T7H005X T8E059X T8K092X T9D140X T9M049X T7H008X T8E060X T8L033X T9E027X T9M050X T7K036X T8H020X T8L099X

Distribution pattern

Worldwide distribution - US Nationwide and Global Distribution.

device · product 7 of 9

Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Z-0007-2021

Recall number: Z-0007-2021
Initiated: August 12, 2020
Classification: Class II
Status: Ongoing
Recalling firm: Covidien, LP
Quantity: 900,007 total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

assembly error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Code information

Lot Numbers: T0A104X T7L042X T8D056X T8L032X T9D044X T0C041X T7L043X T8E053X T8L051X T9D047X T0C042X T7L044X T8E054X T8L104X T9D048X T7F018X T7L045X T8F041X T8L105X T9D049X T7F023X T7L046X T8F042X T8M045X T9D055X T7F024X T7L047X T8F043X T9A007X T9E025X T7J006X T8A005X T8F075X T9A008X T9F051X T7J011X T8A006X T8J011X T9B041X T9H144X T7J012X T8A041X T8K063X T9B042X T9J034X T7K030X T8A042X T8L028X T9C067X T9K078X T7K031X T8C039X T8L029X T9C068X T9K079X T7K032X T8C040X T8L030X T9C146X T9L020X T7K033X T8D055X T8L031X T9C157X T9L034X

Distribution pattern

Worldwide distribution - US Nationwide and Global Distribution.

device · product 8 of 9

Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Z-0008-2021

Recall number: Z-0008-2021
Initiated: August 12, 2020
Classification: Class II
Status: Ongoing
Recalling firm: Covidien, LP
Quantity: 900,007 total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

assembly error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Code information

Lot Numbers: T0A013X T7L050X T8E048X T8K051X T9F118X T0A051X T7L051X T8E055X T8K093X T9G028X T0A085X T7L052X T8E056X T8L129X T9G030X T0B025X T7M021X T8E061X T8L130X T9G038X T0B032X T7M022X T8E062X T8M009X T9G088X T0B046X T8A001X T8E067X T8M011X T9G089X T0B047X T8A002X T8E068X T8M097X T9G090X T0B056X T8A003X T8F001X T9A009X T9G094X T0B073X T8A004X T8F002X T9A031X T9G159X T0B081X T8A045X T8F026X T9A056X T9G160X T0C043X T8A046X T8F045X T9A099X T9H042X T0C068X T8A060X T8F046X T9B001X T9H100X T0C069X T8A061X T8F047X T9B004X T9H101X T0C070X T8B003X T8F077X T9B005X T9H113X T0C103X T8B037X T8H001X T9B038X T9H114X T0D054X T8B038X T8H002X T9C007X T9J030X T0D059X T8B039X T8H003X T9C008X T9J035X T0D061X T8B040X T8H005X T9C069X T9J048X T0D115X T8B041X T8H006X T9C070X T9J073X T0E050X T8C012X T8H019X T9C071X T9J096X T7F019X T8C034X T8H051X T9C156X T9J097X T7F021X T8C035X T8H052X T9E030X T9J098X T7F022X T8C041X T8H072X T9E069X T9K002X T7J003X T8C042X T8J027X T9E070X T9K068X T7J004X T8C044X T8J038X T9E071X T9K104X T7J005X T8D011X T8J041X T9E072X T9K105X T7J013X T8D057X T8J042X T9E111X T9L019X T7J020X T8D058X T8J058X T9E119X T9L074X T7J032X T8D059X T8J067X T9E120X T9L075X T7L028X T8D060X T8K007X T9F026X T9L102X T7L029X T8D061X T8K009X T9F049X T9L103X T7L030X T8D062X T8K043X T9F050X T9M109X T7L048X T8E047X T8K050X T9F078X T9M110X T7L049X

Distribution pattern

Worldwide distribution - US Nationwide and Global Distribution.

device · product 9 of 9

Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Z-0009-2021

Recall number: Z-0009-2021
Initiated: August 12, 2020
Classification: Class II
Status: Ongoing
Recalling firm: Covidien, LP
Quantity: 900,007 total

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

assembly error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Code information

Lot Numbers: 00Z2117

Distribution pattern

Worldwide distribution - US Nationwide and Global Distribution.