Hydro-Surg recallZ-1305-2022 · Davol, Inc. · initiated Jun 7, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Davol, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The product is not able to provide irrigation.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1305-2022
- Status
- Open, Classified
- Initiated by the company
- Jun 7, 2022
- Recalling firm
- Davol, Inc.
- Quantity
- 4,780 (4,390 in US, 390 in Canada)
- Product code
- GCJ
- FDA submissions
- K961492
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Product description
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, 33cm Tip and Cojoined Suction and Irrigation Tubing, Catalog Number 0026870
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Hydro-Surg 0026870Davol Inc. · Laparoscope, general & plastic surgery1 recall209 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 90377).
- Z-1304-2022 · Open, ClassifiedHydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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