The Recall Desk

FDA (Devices) recall action 90377

Davol, Inc. recalled 2 products on 2022-07-06

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2022-07-06
Critical
0
Units
—

Why these products were recalled

The product is not able to provide irrigation.

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • HighFDA (Devices)··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.

    Product
    HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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.

    Product
    HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870
    Category
    Distribution
    0 states