Avid Medical Recalls Davinci Trucustom Bundles Due to Lubricant Contamination
Avid Medical, Inc. is recalling 144 Davinci Trucustom Bundles because they may be contaminated with a lubricant used during manufacturing.
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: The recall is classified as Class II because the product may be contaminated with a lubricant, a hazard that may cause temporary or medically reversible adverse health consequences. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Avid Medical, Inc. is recalling 144 units of the Davinci Trucustom Bundle, specifically model numbers SAMM064-27 and SAMM064-28. The recall was initiated because the products may be potentially contaminated with a lubricant used during the manufacturing process.
The affected products were distributed nationwide in the states of Arizona, California, Florida, Maryland, Nebraska, and Texas. The recall includes specific kit lot numbers and supplier component lots identified in the agency's structured data.
Healthcare facilities and consumers should stop using the affected products and contact Avid Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;
- Manufacturer
- AVID Medical, Inc.
- Hazard
- Affected units
- 144
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)
- 1. Model/Item Number (Kit): SAMM064-27
- UDI-DI: 10809160439708
- Kit Lot Numbers: 1657586
- 1658104
- 1671251
- 2. Model/Item Number (Kit): SAMM064-28
- UDI-DI: 10809160516201
- Kit Lot Numbers: 1698700
- Recalled Supplier Component (in kit): A303416A
- Recalled Supplier Lot Number (in kit): NGKU1749
- NGKV0359
Distribution
Related recalls
Same manufacturer · AVID Medical, Inc.
See all →- ModerateAVID Medical Recalls Heart Prep Trays for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls Plastic Trays Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 33 Endovascular Packs Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAvid Medical Recalls Robotic Prostatectomy Packs for Lubricant Contamination
FDA (Devices) · 2026-10-14
Same hazard · contamination
See all →- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereCarolina Infusion Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls Urology Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereCarolina Infusion Recalls Semaglutide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- ModerateAvid Medical Recalls 30 DAVINCI LAP/GYN Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls Major Packs Due to Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls 33 Endovascular Packs Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAvid Medical Recalls TruCustom DAVINCI PACK Convenience Kits
FDA (Devices) · 2018-03-07
- ModerateAVID Medical Recalls 23 ABD Hysterectomy Kits Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Packs Due to Lubricant Contamination
FDA (Devices) · 2026-10-14