General robotic packs contain an inadvertently resterilized visualization system
PACK GENERAL ROBOTIC medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 656 units are 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 PACK GENERAL ROBOTIC medical convenience kit, model number RDLD047-10, UDI 10809160358603, is being recalled. The action covers 656 units across kit lots including 1589630, 1590570, 1610157 and 1617028.
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 numbers above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- PACK GENERAL ROBOTIC. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 656
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 (11)
- Model No. RDLD047-10
- UDI: 10809160358603
- Kit Lot No. 1589630
- 1590570
- 1610157
- 1617028
- 1618142
- 1621537
- 1629589
- 1635288
- 1636852.
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 →- HighGeneral and laparotomy packs recalled after being sterilized more than once
FDA (Devices) · 2025-10-22
- HighCardiovascular 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
- HighRadiology procedure packs recalled after being sterilized more than once
FDA (Devices) · 2025-10-22
- HighAVID Medical Recalls Halyard LAVH PACK Due to Sterilization Error
FDA (Devices) · 2026-08-26
- HighMedline Convenience Kits Recalled for Sterilization Equipment Calibration
FDA (Devices) · 2026-05-13
- HighGeneral closure kits recalled over sterilization equipment calibration issues
FDA (Devices) · 2026-02-25
- HighDilation and curettage packs recalled after being sterilized more than once
FDA (Devices) · 2025-10-22
- ModerateMedical Device Recall: DeRoyal GU Robotic Pack, 192 Kits
FDA (Devices) · 2022-12-21