CLASS II Device recall · Reported 4 Oct 2017 · FDA Enforcement Report
Percuvance Johans Grasper Tool Tip The Percutaneous recalled
Teleflex Medical is recalling Percuvance Johans Grasper Tool Tip The Percutaneous Surgical System with attachments is, distributed nationwide in the US. The recall was initiated on 19 Jul 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3221-2017
- FDA event ID
- 77974
- Recalling firm
- Teleflex Medical, Morrisville, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jul 2017
- FDA classified
- 27 Sep 2017
- Reported
- 4 Oct 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 19 Jul 2017 | Recall initiated by company | |
| 27 Sep 2017 | Classified by FDA | +70 days |
| 4 Oct 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.
Product as listed by the FDA
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 soft tissue during laparoscopic surgery.
Where it was distributed
Worldwide Distribution - US including AL, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV Internationally to United Arab Emirates, Vienna, Australia, Belgium, Switzerland, China, Germany, Czech Republic, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iran, Italy, Japan, South Korea, R¿publique du Liban, Netherlands, Norway, Qatar, Romania, Saudi Arabia, Republic of Singapore, Turkey, Taiwan, and South Africa
Nationwide AlabamaArizonaCaliforniaFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMinnesotaMissouriNorth CarolinaNew JerseyNew YorkOhioOregon
Questions about this recall
Is Percuvance Johans Grasper Tool Tip The Percutaneous Surgical System with attachments is recalled?
Yes. Teleflex Medical recalled Percuvance Johans Grasper Tool Tip The Percutaneous Surgical System with attachments is on 19 Jul 2017. The recall is Class II and its status is Terminated. Recall number Z-3221-2017.
Why was it recalled?
For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.
Which lots are affected?
Lot #'s: 73A1600104, 73B1600339, 73C1600291, 73C1600454, 73D1600586, 73E1600586, 73G1600016, 73G1600558, 73G1600728, 73H1600148, 73H1600507, 73H1600901, 73J1600061, 73J1600601, 73L1600024, 73L1600376, 73L1600559, 73M1500035, and 73M1500300
Where was it sold?
Worldwide Distribution - US including AL, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV Internationally to United Arab Emirates, Vienna, Australia, Belgium, Switzerland, China, Germany, Czech Republic, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iran, Italy, Japan, South Korea, R¿publique du Liban, Netherlands, Norway, Qatar, Romania, Saudi Arabia, Republic of Singapore, Turkey, Taiwan, and South Africa
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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