AVID Medical, Inc. Davinci Trucustom Bundle recall: Product may be potentially contaminated with a lubricant used during
Product may be potentially contaminated with a lubricant used during the manufacturing process.
The hazard: Device safety concern
A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
What the notice says: Product may be potentially contaminated with a lubricant used during the manufacturing process.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-0092-2027
- Published
- October 14, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- AVID Medical, Inc.
- Product type
- Medical devices
- Units affected
- 144
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- 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;
- UPC codes
- 10809160439708, 10809160516201
Products covered by this recall
DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;
Check your product
The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 10809160439708
- 10809160516201
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- 1657586
- 1658104
- 1671251
- 1698700
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
AVID Medical, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- Ask the supplier or clinic that provided it what the remedy is in your case.
- If you are a facility, quarantine affected stock and log the correction.
- Report device problems to the FDA through MedWatch.
Claiming on a recalled device
Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.
- Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
- Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
- If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
- Log the date, the name and the reference number of every call. Device recalls can run for months.
Company contact: AVID Medical, Inc. — 9000 Westmont Dr, Toano, VA, 23168-9351
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was AVID Medical, Inc. medical devices recalled?
Product may be potentially contaminated with a lubricant used during the manufacturing process. Product may be potentially contaminated with a lubricant used during the manufacturing process.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 10809160439708, 10809160516201; lot code 1657586, 1658104, 1671251. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
Where was the recalled product sold?
It was distributed nationwide.
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