The Recall Desk
HighFDA (Devices)·Z-1305-2022·Announced 2022-07-06

Laparoscopic irrigator recalled for inability to provide irrigation

Davol, Inc. is recalling the HydroSurg Plus Laparoscopic Irrigator because the device cannot provide irrigation as intended. The recall affects 4,390 units in the US and 390 in Canada.

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: This is a Class II medical device recall involving a functional defect that prevents the product from providing irrigation as intended. While the device presents a risk-of-harm scenario in surgical use, no illnesses or injuries have been reported.

Plain-English summary

Davol, Inc. is recalling the HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve (Catalog Number 0026870) due to a functional defect. The device is not able to provide irrigation as intended during laparoscopic surgical procedures.

The recall affects 4,390 units distributed in the United States and 390 units distributed in Canada. The affected products are identified by the following lot numbers: JUFY0738, JUFY0762, JUFY0746, JUFY0752, JUFY0758, JUFY0759, and JUFY1655.

The recalled product

Product
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870
Manufacturer
Davol, Inc.
Hazard
  • device-malfunction
  • irrigation-failure

Distribution

Distributed nationwide across the United States.