CLASS II ONGOING Device recall · Reported 6 Jul 2022 · FDA Enforcement Report
HydroSurg Plus Laparoscopic Irrigator recalled by Davol
Davol is recalling HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle, distributed nationwide in the US. The recall was initiated on 7 Jun 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1304-2022
- FDA event ID
- 90377
- Recalling firm
- Davol, Warwick, RI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Jun 2022
- FDA classified
- 30 Jun 2022
- Reported
- 6 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 7 Jun 2022 | Recall initiated by company | |
| 30 Jun 2022 | Classified by FDA | +23 days |
| 6 Jul 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product is not able to provide irrigation.
Product as listed by the FDA
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
Why was it recalled?
The product is not able to provide irrigation.
Which lots are affected?
UDI: (01)00801741010224(17)241028(10)JUFX2830 (01)00801741010224(17)241028(10)JUFY0743 Lots JUFX2830 JUFY0743
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 90377This product is part of a recall event; the main page for the event is HydroSurg Plus Laparoscopic Irrigator recalled by Davol.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | HydroSurg Plus Laparoscopic Irrigator recalled by Davol | Davol | Other | Nationwide |
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