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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74774

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

Open FDA event record

Event summary

Timeline bucket
June 27, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ConMed Corporation

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

7 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 7

CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.

Z-0129-2017
Recall number
Z-0129-2017
Initiated
June 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
ConMed Corporation
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility

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 packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

Code information

Beginning Lot Code 110609X to Ending Lot Code 20160308X

Distribution pattern

Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.

device · product 2 of 7

CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8190 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.

Z-0130-2017
Recall number
Z-0130-2017
Initiated
June 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
ConMed Corporation
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility

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 packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

Code information

Beginning Lot Code 110609X to Ending Lot Code 20160308X

Distribution pattern

Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.

device · product 3 of 7

CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 The CORE Suction/Irrigation Y Tubing Set with Trumpet Valves (CD8200) is indicated for use in gynecological and abdominal surgery for

Z-0131-2017
Recall number
Z-0131-2017
Initiated
June 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
ConMed Corporation
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility

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 packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

Code information

Beginning Lot Code 110609X to Ending Lot Code 20160308X

Distribution pattern

Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.

device · product 4 of 7

CORE¿ Suction Irrigation Handpiece without Probe for Single Solution Bags, Catalog Number CD8300 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.

Z-0132-2017
Recall number
Z-0132-2017
Initiated
June 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
ConMed Corporation
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility

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 packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

Code information

Beginning Lot Code 110609X to Ending Lot Code 20160308X

Distribution pattern

Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.

device · product 5 of 7

CORE¿ Suction Irrigation Handpiece without Probe for Single Solution or Dual Bags, Catalog Number CD8302 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.

Z-0133-2017
Recall number
Z-0133-2017
Initiated
June 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
ConMed Corporation
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility

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 packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

Code information

Beginning Lot Code 110609X to Ending Lot Code 20160308X

Distribution pattern

Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.

device · product 6 of 7

CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures

Z-0134-2017
Recall number
Z-0134-2017
Initiated
June 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
ConMed Corporation
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility

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 packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

Code information

Beginning Lot Code 110609X to Ending Lot Code 20160308X

Distribution pattern

Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.

device · product 7 of 7

CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures

Z-0135-2017
Recall number
Z-0135-2017
Initiated
June 27, 2016
Classification
Class II
Status
Terminated
Recalling firm
ConMed Corporation
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility

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 packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.

Code information

Beginning Lot Code 110609X to Ending Lot Code 20160308X

Distribution pattern

Worldwide Distribution - US (Nationwide) Internationally: to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, United Kingdom, Guatemala, Czech Republic & Canada.