Severity
Moderate
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
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-0059-2018) was formally reported on November 8, 2017, with the manufacturer initiating the action on October 18, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Teleflex Medical is listed as the recalling firm, operating out of Research Triangle Park, NC. Federal records list the affected scope as 3904 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Belgium, Hong Kong, Japan, S. Korea and Singapore.. Distribution scope 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 - 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.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
3904 units
Related Recalls
6
0 from same agency
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
| 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.
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? ▼
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.. Recalled by Teleflex Medical. Units affected: 3904 units.
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0059-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 8, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.