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.
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: 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.
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Davol, Inc.
See all →- HighAvitene Ultrafoam Microfibrillar Collagen Hemostat Recalled for Foreign Matter
FDA (Devices) · 2026-04-29
- HighHernia repair mesh balloon may not inflate during surgery
FDA (Devices) · 2023-08-02
- HighVentral Hernia Mesh Balloon May Fail to Inflate During Surgery
FDA (Devices) · 2023-08-02
- HighHernia repair implant balloon may not inflate as intended
FDA (Devices) · 2023-08-02
- HighSurgical mesh inflation malfunction in Ventralight ST hernia repair device
FDA (Devices) · 2023-08-02
Same hazard · irrigation failure
See all →- HighLaparoscopic irrigator recalled for inability to provide irrigation
FDA (Devices) · 2022-07-06
Similar recalls
- HighIntuitive Surgical Recalls EndoWrist Suction Irrigator Due to Silicone Particle Risk
FDA (Devices) · 2019-11-06
- HighStryker StrykeFlow suction irrigator may leak solution into the handpiece
FDA (Devices) · 2025-07-30
- HighIntegra Selector Kit Tubing Recalled for Potential Irrigation Fluid Leakage
FDA (Devices) · 2014-12-10
- HighVASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System Recalled for Sterilization Failure
FDA (Devices) · 2023-04-12
- HighGA Health Recalls ScopeValet Guardian Disposable Endoscope Valves Due to Defect
FDA (Devices) · 2020-12-30
- HighFDA Recalls 59,828 Covidien Surgiwand II Suction and Irrigation Devices
FDA (Devices) · 2021-04-21