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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81909

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

Open FDA event record

Event summary

Timeline bucket
January 03, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Teleflex Medical

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

2 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 2

Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.

Z-0753-2019
Recall number
Z-0753-2019
Initiated
January 03, 2018
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
1751 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.

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

There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.

Code information

Batch/Lot Numbers: 73A1700531, 73B1700180, 73F1700583, 73F1700584, 73F1700585, 73H1700728, 73J1600394, 73J1700072, 73J1700073, 73J1700074, 73J1700554

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, Czech Republic, France, Germany, Great Britain, Iran, Ireland, Italy, Japan, Lebanon, Netherlands, Qatar, Romania, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, and the United Arab Emirates.

device · product 2 of 2

Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate Intended Use: soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.

Z-0754-2019
Recall number
Z-0754-2019
Initiated
January 03, 2018
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
1962 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.

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

There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality and security of the tool tip. Should this occur during use, surgical intervention may be required.

Code information

Batch/Lot Numbers: 73A1700535, 73B1600170, 73B1700073, 73B1700523, 73B1700646, 73C1600058, 73C1600706, 73D1600482, 73F1600086, 73G1600207, 73G1600468, 73G1600573, 73G1700041, 73G1700311, 73G1700577, 73H1600509, 73H1700513, 73H1700526, 73H1700531, 73H1700532, 73J1700100, 73J1700553, 73M1600016, 73M1600027, 73M1600231

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, Czech Republic, France, Germany, Great Britain, Iran, Ireland, Italy, Japan, Lebanon, Netherlands, Qatar, Romania, Saudi Arabia, Singapore, Spain, Taiwan, Turkey, and the United Arab Emirates.