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.
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: 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.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Davol, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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