FDA Medical Device Recalls (openFDA)
Davol, Inc.: HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880
- Recall number
- Z-1304-2022
- Recalling firm
- Davol, Inc.
- Product
- HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880
- Status
- Open, Classified
- Initiated
- 2022-06-07
- Posted
- not on file
- Terminated
- not on file
- Reason
- The product is not able to provide irrigation.
- 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
- 4,780 (4,390 in US, 390 in Canada)
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot, serial or model codes
- UDI: (01)00801741010224(17)241028(10)JUFX2830 (01)00801741010224(17)241028(10)JUFY0743 Lots JUFX2830 JUFY0743
- 510(k) numbers
- ["K961492"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 1213643
- Firm city
- Warwick
- Firm state
- RI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28