Teleflex Percuvance Johans Grasper Tool Tip Recall for Connection and Jaw Issues
Teleflex Medical is recalling Percuvance Johans Grasper Tool Tips because the shaft connection may be compromised or the jaws may close abruptly.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential mechanical failure (compromised connection or abrupt jaw closure) that could pose a risk of harm during surgery, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Teleflex Medical is recalling specific lots of the Percuvance Johans Grasper Tool Tip, a component of the Percutaneous Surgical System used in laparoscopic surgery. The recall involves 20,039 units distributed worldwide, including in the United States and various international markets.
The recall was initiated because the security of the connection between the shaft and the tool tip may be compromised for some products. Additionally, for certain other lots, the jaws of the tool tips may close abruptly. The affected lots are identified by specific lot numbers provided in the recall documentation.
Healthcare providers and facilities that have received these products should stop using them and contact Teleflex Medical for further instructions. Consumers are not directly affected as this is a professional medical device used in surgical settings.
The recalled product
- Product
- Percuvance Johans Grasper Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate 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…
- Manufacturer
- Teleflex Medical
- Affected units
- 20,039
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- Lot #'s: 73A1600104
- 73B1600339
- 73C1600291
- 73C1600454
- 73D1600586
- 73E1600586
- 73G1600016
- 73G1600558
- 73G1600728
- 73H1600148
- 73H1600507
- 73H1600901
- 73J1600061
- 73J1600601
- 73L1600024
- 73L1600376
- 73L1600559
- 73M1500035
- and 73M1500300
Distribution
Part of a larger recall action
This product is one of 6 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Similar recalls
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