AVID Medical Custom Surgical Procedure Kits
Davinci Trucustom Bundle may be contaminated with a lubricant used during manufacturing.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
AVID Medical, Inc. recalled multiple products, including the Davinci Trucustom Bundle, because the products may be potentially contaminated with a lubricant used during the manufacturing process. The recall began on August 10, 2026, and was added to the FDA's Enforcement Report on October 7, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
15 products
Affected if its UDI-DI and lot code are listed under that product.
Davinci Trucustom Bundle; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;
- UDI-DI
- 10809160439708
- 10809160516201
- Lot
- 1657586
- 1658104
- 1671251
- 1698700
- NGKU1749
- NGKV0359
Laparoscopic Prostatectomy; Model/Item Number (Kit): NIHB0036-07;
- UDI-DI
- 10809160403099
- Lot
- 1657751
- NGKT3375
ABD Hysterectomy; Model/Item Number (Kit): NAMC438-07;
- UDI-DI
- 10809160417645
- Lot
- 1675123
- 1675125
- 1679551
- NGKT2404
Plastics Tray; Model/Item Number (Kit): EURO053;
- UDI-DI
- 10809160423813
- Lot
- 1674613
- NGKU3975
Major Pack; Model/Item Number (Kit): NIHB0018-11;
- UDI-DI
- 10809160403747
- Lot
- 1667763
- NGKT3375
Davinci LAP/GYN; Model/Item Number (Kit): WRNM037-16;
- UDI-DI
- 10809160468913
- Lot
- 1663589
- NGKT3375
Robotic Prostatectomy Pack; Model/Item Number (Kit): NAMC423-11;
- UDI-DI
- 10809160490808
- Lot
- 1671502
- NGKT2404
Endovascular Pack; Model/Item Number (Kit): VAPX014-04;
- UDI-DI
- 10809160332863
- Lot
- 1701106
- 1702175
- 1702273
- NGKU4043
GYN Laparoscopy Pack; Model/Item Number (Kit): NAMC436-12;
- UDI-DI
- 10809160468470
- Lot
- 1697826
- NGKT3314
Urology Major; Model/Item Number (Kit): WRNM058-10;
- UDI-DI
- 10809160488898
- Lot
- 1681989
- NGKU2887
Pack Open Heart CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07;
- UDI-DI
- 10809160487334
- 10809160513170
- Lot
- 1666214
- 1672814
- 1695181
- NGKT2404
- NGKT3314
Heart Prep Tray; Model/Item Number (Kit): MECV97W;
- UDI-DI
- 10809160493113
- Lot
- 1691836
- 1696316
- NGKV2393
Craniotomy Pack; Model/Item Number (Kit): WRNM035-20;
- UDI-DI
- 10809160489277
- Lot
- 1695943
- NGKT2391
Adult Heart Tray Shands Jacks; Model/Item Number (Kit): SHND419-08;
- UDI-DI
- 10809160502389
- Lot
- 1680504
- 1695337
- NGKW2687
- NGKV2393
GYN Laparoscopy/Laparotomy; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;
- UDI-DI
- 10809160487181
- 10809160399781
- Lot
- 1666722
- 1659079
- 1696378
- NGKU3975
- NGKU2887
Details
- Company began the recall
- Event ID
- 99808
- Company
- AVID Medical, Inc.
- Hazard
- Contamination
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
