Ethicon Recalls Endopath Electrosurgery Probes Due to Potential Sterility Compromise
Ethicon Endo-Surgery Inc is recalling 327,648 Endopath Electrosurgery Probe Plus II instruments because a tear in the Tyvek packaging may affect the sterility of the devices.
What this means for you
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 is classified as FDA Class II, and the hazard involves a potential loss of sterility in a medical device used in surgical procedures, which poses a risk of harm (infection) even though specific injuries are not reported in the source text.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling 327,648 units of the Endopath Electrosurgery Probe Plus II system. The recall involves twelve different device types, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices, and stone retrieval cannula. These instruments are packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid.
The firm is recalling the devices because there is a possibility that a tear in the Tyvek packaging may affect the sterility of the device. The affected products include specific product codes (EPS01 through EPS08, EPS10 through EPS13) with expiration dates ranging from April 2013 to March 2018.
The recalled instruments were distributed worldwide, including nationwide distribution in the United States and in numerous countries across North America, South America, Europe, Asia, Africa, and the Middle East. The Endopath Electrosurgery Probe Plus II system is used in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation.
The recalled product
- Product
- 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 flex
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 327,648
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 (15)
- Product Code: EPS01
- Exp. Date: 2015 09 through 2018 03
- Product Code: EPS02
- Product Code: EPS03
- Product Code: EPS04
- Product Code: EPS05
- Product Code: EPS06
- Product Code: EPS07
- Product Code: EPS08
- Product Code: EPS10
- Exp. Date: 2013 04 through 2018 03
- Product Code: EPS11
- Product Code: EPS12
- Exp. Date: 2013 04 through 2018 03 & Product Code: EPS13
- Exp. Date: 2013 04 through 2018 03.
Distribution
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