Reported Jul 31, 2013 · Terminated
Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved…
Ethicon Endo-Surgery Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ethicon Endo-Surgery Inc · 4545 Creek Rd · Cincinnati, OH · 45242-2803
Is this the product you have?
- Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugated shipper. The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.
- Lot codes and dates
11 of 11 products
Products covered by this recall Model / number Product as published EPS01Exp. Date: 2015 09 through 2018 03 EPS02Exp. Date: 2015 09 through 2018 03 EPS03Exp. Date: 2015 09 through 2018 03 EPS04Exp. Date: 2015 09 through 2018 03 EPS05Exp. Date: 2015 09 through 2018 03 EPS06Exp. Date: 2015 09 through 2018 03 EPS07Exp. Date: 2015 09 through 2018 03 EPS08Exp. Date: 2015 09 through 2018 03 EPS10Exp. Date: 2013 04 through 2018 03 EPS11Exp. Date: 2013 04 through 2018 03 EPS13Product Code: EPS12, Exp. Date: 2013 04 through 2018 03 & , Exp. Date: 2013 04 through 2018 03. - Amount recalled
- 327,648 instruments
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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