Z-1305-2022Class II

HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined...

Name: Z-1305-2022 HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined...
Creator: Davol, Inc.
Published: 2022-06-07
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2022-06-07 / Open, Classified

FDA source

Davol, Inc. began a recall of HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870 on 2022-06-07. FDA classified it as Class II and gives the reason as "The product is not able to provide irrigation". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1305-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-07
Posted: 2022-06-30
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
Product: HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: The product is not able to provide irrigation.
FDA root cause: Under Investigation by firm
Action: On June 7, 2022, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were instructed to destroy all affected product remaining in their possession.
Quantity in commerce: 4,780 (4,390 in US, 390 in Canada)
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1305-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1304-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-06	2022-06-30
Z-1305-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-06	2022-06-30

Product code GCJ

K961492Class IIHydro-Surg Laparoscopic Irrigaton Models 0026000. 0026010Davol Inc., Sub. C. R. Bard, Inc. / cleared 1996-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)