The Recall Desk
HighFDA (Devices)·Z-1304-2022·Announced 2022-07-06

HydroSurg Plus Laparoscopic Irrigator recalled for inability to irrigate

Davol HydroSurg Plus Laparoscopic Irrigators cannot provide irrigation. The FDA issued a Class II recall affecting 4,780 units worldwide.

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: FDA Class II recall of a surgical instrument without reported hospitalizations or injuries. The product's inability to provide irrigation represents a functional failure in a risk-of-harm medical device, though no adverse events have been reported.

Plain-English summary

Davol, Inc. is recalling the HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve (Catalog number 0026880). The recalled product is the handle unit with cojoined suction and irrigation tubing.

The product is unable to provide irrigation. This is a Class II recall issued by the FDA.

Approximately 4,780 units have been distributed worldwide, including 4,390 in the United States and 390 in Canada. The affected units are identified by lot numbers JUFX2830 or JUFY0743.

Users who have received this product should verify the lot number and contact Davol, Inc. for instructions regarding return or replacement of affected units.

The recalled product

Product
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880
Manufacturer
Davol, Inc.
Hazard
  • irrigation-failure
  • device-malfunction

Distribution

Distributed nationwide across the United States.