The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1772-2013·Announced 2013-07-31

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.

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 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…
Manufacturer
Ethicon Endo-Surgery Inc
Category
Medical Device — Surgical Instruments
Hazard
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

Distributed nationwide across the United States.

The notice also names 44 states specifically:

Related recalls

Same manufacturer · Ethicon Endo-Surgery Inc

See all →

Same hazard · sterility compromise

See all →

Similar recalls