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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73427

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

Open FDA event record

Event summary

Timeline bucket
March 03, 2016
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

13 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 13

Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.

Z-1847-2016
Recall number
Z-1847-2016
Initiated
March 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
713600

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Compromised sterility due to breach of barrier

Code information

All lots beginning with 110000037462 through Lot 120002259962

Distribution pattern

Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

device · product 2 of 13

Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x 43.2 cm) Item Number: 4034

Z-1848-2016
Recall number
Z-1848-2016
Initiated
March 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
114720

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Compromised sterility due to breach of barrier

Code information

All lots beginning with 110000142862 through lot 130002191062X

Distribution pattern

Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

device · product 3 of 13

Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047

Z-1849-2016
Recall number
Z-1849-2016
Initiated
March 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
2418560

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Compromised sterility due to breach of barrier

Code information

All lots beginning with 110000233562 through lot 120002651262X

Distribution pattern

Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

device · product 4 of 13

Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 66 cm) Item Number: 4031

Z-1850-2016
Recall number
Z-1850-2016
Initiated
March 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
208348

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Compromised sterility due to breach of barrier

Code information

All lots beginning with 110000311162 through lot 15J101262X

Distribution pattern

Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

device · product 5 of 13

Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 4037

Z-1851-2016
Recall number
Z-1851-2016
Initiated
March 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
28085

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Compromised sterility due to breach of barrier

Code information

All lots beginning with 110000311262 through lot 15G162262X

Distribution pattern

Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

device · product 6 of 13

Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number: 6022

Z-1852-2016
Recall number
Z-1852-2016
Initiated
March 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
996002

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Compromised sterility due to breach of barrier

Code information

All lots beginning with 110000463762 through lot 15K235262

Distribution pattern

Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

device · product 7 of 13

Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 36" (20.3 cm x 91.4 cm Item Number: 6056

Z-1853-2016
Recall number
Z-1853-2016
Initiated
March 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
36040

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Compromised sterility due to breach of barrier

Code information

All lots beginning with 110001358162 through lot 15C033262X

Distribution pattern

Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

device · product 8 of 13

Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number:6522

Z-1854-2016
Recall number
Z-1854-2016
Initiated
March 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
3152197

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Compromised sterility due to breach of barrier

Code information

All lots beginning with 110000161662 through lot 15G255462X

Distribution pattern

Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

device · product 9 of 13

Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 12" x 12" (30.5 cm x 30.5 cm) Item Number:6534

Z-1855-2016
Recall number
Z-1855-2016
Initiated
March 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
350550

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Compromised sterility due to breach of barrier

Code information

All lots beginning with 110000476162 through lot 15J070162X

Distribution pattern

Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

device · product 10 of 13

Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 cm x 45.7 cm) Item Number: 6545

Z-1856-2016
Recall number
Z-1856-2016
Initiated
March 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
70960

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Compromised sterility due to breach of barrier

Code information

All lots beginning with 110001420362 through lot 15C151862X

Distribution pattern

Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

device · product 11 of 13

Curity" X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (20.3 cm x 91.4 cm) Item Number: 6556

Z-1857-2016
Recall number
Z-1857-2016
Initiated
March 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
87680

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Compromised sterility due to breach of barrier

Code information

All lots beginning with 100000055262 through lot 15B223462X

Distribution pattern

Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

device · product 12 of 13

Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319

Z-1858-2016
Recall number
Z-1858-2016
Initiated
March 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
372480

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Compromised sterility due to breach of barrier

Code information

All lots beginning with 100000010062 through lot 15J162962X

Distribution pattern

Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

device · product 13 of 13

Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321

Z-1859-2016
Recall number
Z-1859-2016
Initiated
March 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
Covidien LLC
Quantity
199488

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Compromised sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Compromised sterility due to breach of barrier

Code information

All lots beginning with 100000009962 through lot 15J163262X

Distribution pattern

Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.