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 Tip and, 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

Lot, batch or date codesUDI: (01)00801741000362(17)241028(10)JUFY0738 (01)00801741000362(17)241028(10)JUFY0762 (01)00801741000362(17)241028(10)JUFY0746 (01)00801741000362(17)241028(10)JUFY0752 (01)00801741000362(17)241028(10)JUFY0758 (01)00801741000362(17)241028(10)JUFY0759 (01)00801741000362(17)241028(10)JUFY1655 Lots JUFY0738 JUFY0762 JUFY0746 JUFY0752 JUFY0758 JUFY0759 JUFY1655
Quantity recalled4,780 (4,390 in US, 390 in Canada)

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-1305-2022
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

Timeline

7 Jun 2022Recall initiated by company
30 Jun 2022Classified by FDA+23 days
6 Jul 2022Published 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, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Nationwide

Questions about this recall

Why was it recalled?

The product is not able to provide irrigation.

Which lots are affected?

UDI: (01)00801741000362(17)241028(10)JUFY0738 (01)00801741000362(17)241028(10)JUFY0762 (01)00801741000362(17)241028(10)JUFY0746 (01)00801741000362(17)241028(10)JUFY0752 (01)00801741000362(17)241028(10)JUFY0758 (01)00801741000362(17)241028(10)JUFY0759 (01)00801741000362(17)241028(10)JUFY1655 Lots JUFY0738 JUFY0762 JUFY0746 JUFY0752 JUFY0758 JUFY0759 JUFY1655

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 90377
ReportedClassRecallCompanyReasonWhere
CLASS IIHydroSurg Plus Laparoscopic Irrigator recalled by DavolDavolOtherNationwide

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