ModerateClass IITerminated

FDA Devices recall · Reported November 8, 2017

Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic Johans Grasper, Catalog Number PCVJG5 (b) 5 mm Maryland Dissector, Catalog Number PCVMD5 (c) 5 mm Hem-o-lok Clip Applier, Catalog Number PCVHCA5 (d) 5 mm Traumatic Gripper Grasper, Catalog Number PCVGG5 (e) 5 mm Scissors, Catalog Number PCVSC5 The Percuvance Percutaneous Surgical System is a family of instruments used to perform laparoscopic procedures. Without the need for additional insertion condu

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on November 8, 2017. Severity: Moderate. Recall number: Z-0059-2018.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Belgium, Hong Kong, Japan, S. Korea and Singapore..

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use.

Recall #: Z-0059-2018
Affected scope: 3904 units
Initiated: October 18, 2017

Compiled from official public sources by the publisher. · Updated September 2026

Verify with FDA Devices →

View my saved recalls

Teleflex Medical recalled Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic… - a moderate-severity action.

Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic… was recalled by Teleflex Medical in November 8, 2017. Reason: Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the t…. Check the official notice for the remedy. Verify recall #Z-0059-2018 with the FDA Devices before acting.

The recall

Teleflex Medical issued this moderate-severity FDA Devices recall-Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the t….

Moderate
severity level: 4K units
affected scope: Class II
classification: November 8, 2017
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0059-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Teleflex(R) Percuvance(TM) Percutaneous Surgical System, Components: (a) 5 mm Atraumatic Johans Grasper, Catalog Number PCVJG5 (b) 5 mm Maryland Dissector, Catalog Number PCVMD5 (c) 5 mm Hem-o-lok Clip Applier, Catalog Number PCVHCA5 (d) 5 mm Traumatic Gripper Grasper, Catalog Number PCVGG5 (e) 5 mm Scissors, Catalog Number PCVSC5 The Percuvance Percutaneous Surgical System is a family of instruments used to perform laparoscopic procedures. Without the need for additional insertion conduits (trocars), the 2.9mm insulated Shafts are inserted percutaneously with the assistance of an Introducer needle tool tip. The Shaft is then advanced retrograde through a 5mm, or larger, port to facilitate the extracorporeal attachment of interchangeable Tool Tips. These interchangeable tools can be used to grasp, retract, manipulate, cut, coagulate and deliver Hem-o-lok¿ ligating clips to soft tissue. Each Percuvance System Handle includes an integrated male cautery adapter that can be connected to most monopolar electrosurgical units (ESU) via a standard 4mm monopolar cable.

Reason for recall

Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0059-2018
Date reported	November 8, 2017
Date initiated	October 18, 2017
Recalling firm	Teleflex Medical
Firm location	Research Triangle Park, NC
Affected scope	3904 units
Distribution	Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Belgium, Hong Kong, Japan, S. Korea and Singapore.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

3904 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0059-2018) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Teleflex is recalling these products because the jaws of the tool tip may break, causing a fragment of the tool tip to fall off during use.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on November 8, 2017. Severity: Moderate. Recall number: Z-0059-2018.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Belgium, Hong Kong, Japan, S. Korea and Singapore..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

OshKosh Recalls Baby B'gosh Quilted Jacke… 2017-11-08 Duloxetine Delayed-release Capsules USP, … 2017-11-08 A1 Slim, Dietary Supplement Beautifully S… 2017-11-08 SUCcinylcholine 20 mg per mL, Total Volum… 2017-11-08

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

HYDROmorphone HCL 1 mg per mL in 0.9% Sod… 2017-11-08 morphine sulfate 1 mg per mL in 0.9% Sodi… 2017-11-08 PHENYLephrine HCl 100 mcg per mL In 0.9% … 2017-11-08 ROCuronium Bromide 10 mg per mL, 5 mL Fil… 2017-11-08

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported November 8, 2017. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026