daVinci urology and prostate packs contain a resterilized visualization system
DA VINCI PACK URO/PROSTATE medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 21 units affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall over discoloration from an unintended resterilization, with no device defect or clinical consequence stated in the source.
Plain-English summary
The DA VINCI PACK URO/PROSTATE medical convenience kit, model number VAHT009-19, UDI 10809160378748, is being recalled. The action covers 21 units from kit lot 1579555.
The stated reason is that the Clearify Visualization System was inadvertently resterilized in the kits, causing discoloration. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Distribution was domestic, to California, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington. The kits are supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the model number, UDI and kit lot number above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- DA VINCI PACK URO/PROSTATE. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 21
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. VAHT009-19
- UDI: 10809160378748
- Kit Lot No. 1579555.
Distribution
Part of a larger recall action
This product is one of 24 recalled by AVID Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 24 products in this recall →Related recalls
Same manufacturer · AVID Medical, Inc.
See all →- ModerateAvid Medical Recalls 30 DAVINCI LAP/GYN Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAvid Medical Recalls Davinci Trucustom Bundles Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Packs Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls Urology Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
Same hazard · resterilization
See all →- HighCardiovascular procedure packs recalled after being sterilized more than once
FDA (Devices) · 2025-10-22
- HighRadiology procedure packs recalled after being sterilized more than once
FDA (Devices) · 2025-10-22
- HighDilation and curettage packs recalled after being sterilized more than once
FDA (Devices) · 2025-10-22
- HighCardiac catheterization packs recalled after being sterilized more than once
FDA (Devices) · 2025-10-22
- HighCentral line insertion kits recalled after being sterilized more than once
FDA (Devices) · 2025-10-22
Similar recalls
- HighUrological procedural kits recalled due to sterilization defects
FDA (Devices) · 2024-02-07
- HighAVID Medical Recalls Halyard LAVH PACK Due to Sterilization Error
FDA (Devices) · 2026-08-26
- HighRadiology procedure packs recalled after being sterilized more than once
FDA (Devices) · 2025-10-22
- HighDilation and curettage packs recalled after being sterilized more than once
FDA (Devices) · 2025-10-22
- HighMedline Convenience Kits Recalled for Sterilization Equipment Calibration
FDA (Devices) · 2026-05-13
- ModerateAvid Medical Recalls 30 DAVINCI LAP/GYN Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14