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Class IIOngoing

AVID Medical, Inc. recalls 15 products

Recall date · record updated Oct 14, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
AVID Medical, Inc.
Reason
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99808…

Products (15)

  1. DAVINCI TRUCUSTOM BUNDLE; Model/Item Number (Kit): 1. SAMM064-27, 2. SAMM064-28;

    Codes/lots: 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;Quantity: 144Recall no. Z-0092-2027Class II
  2. GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;

    Codes/lots: 1. Model/Item Number (Kit): WRNM002-15; UDI-DI: 10809160487181; Kit Lot Numbers: 1666722; 2. Model/Item Number (Kit): FBCH108-03; UDI-DI: 10809160399781; Kit Lot Numbers: 1659079, 1696378; Recalled Supplier Component (in kit): A942216; Recalled Supplier Lot Number (in kit): NGKU3975, NGKU2887;Quantity: 134Recall no. Z-0093-2027Class II
  3. ADULT HEART TRAY SHANDS JACKS; Model/Item Number (Kit): SHND419-08;

    Codes/lots: 1. Model/Item Number (Kit): SHND419-08; UDI-DI: 10809160502389; Kit Lot Numbers: 1680504, 1695337; Recalled Supplier Component (in kit): A319514AM; Recalled Supplier Lot Number (in kit): NGKW2687, NGKV2393;Quantity: 59Recall no. Z-0094-2027Class II
  4. ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04;

    Codes/lots: 1. Model/Item Number (Kit): VAPX014-04; UDI-DI: 10809160332863; Kit Lot Numbers: 1701106, 1702175, 1702273; Recalled Supplier Component (in kit): A902416; Recalled Supplier Lot Number (in kit): NGKU4043;Quantity: 33Recall no. Z-0095-2027Class II
  5. CRANIOTOMY PACK; Model/Item Number (Kit): WRNM035-20;

    Codes/lots: 1. Model/Item Number (Kit): WRNM035-20; UDI-DI: 10809160489277; Kit Lot Numbers: 1695943; Recalled Supplier Component (in kit): A319516AM; Recalled Supplier Lot Number (in kit): NGKT2391;Quantity: 10Recall no. Z-0096-2027Class II
  6. PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07;

    Codes/lots: 1. Model/Item Number (Kit): UFCF004-06; UDI-DI: 10809160487334; Kit Lot Numbers: 1666214, 1672814; 2. Model/Item Number (Kit): UFCF004-07; UDI-DI: 10809160513170; Kit Lot Numbers: 1695181; Recalled Supplier Component (in kit): A119216M; Recalled Supplier Lot Number (in kit): NGKT2404, NGKT3314;Quantity: 124Recall no. Z-0097-2027Class II
  7. ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;

    Codes/lots: Model/Item Number (Kit): NAMC423-11; UDI-DI: 10809160490808; Kit Lot Numbers: 1671502; Recalled Supplier Component (in kit): A119216M; Recalled Supplier Lot Number (in kit): NGKT2404;Quantity: 6Recall no. Z-0098-2027Class II
  8. LAPAROSCOPIC PROSTATECTOMY; Model/Item Number (Kit): NIHB0036-07;

    Codes/lots: Model/Item Number (Kit): NIHB0036-07; UDI-DI: 10809160403099; Kit Lot Numbers: 1657751; Recalled Supplier Component (in kit): A942216; Recalled Supplier Lot Number (in kit): NGKT3375;Quantity: 15Recall no. Z-0099-2027Class II
  9. PLASTICS TRAY; Model/Item Number (Kit): EURO053;

    Codes/lots: Model/Item Number (Kit): EURO053; UDI-DI: 10809160423813; Kit Lot Numbers: 1674613; Recalled Supplier Component (in kit): A902416; Recalled Supplier Lot Number (in kit): NGKU3975;Quantity: 28Recall no. Z-0100-2027Class II
  10. DAVINCI LAP/GYN; Model/Item Number (Kit): WRNM037-16;

    Codes/lots: Model/Item Number (Kit): WRNM037-16; UDI-DI: 10809160468913; Kit Lot Numbers: 1663589; Recalled Supplier Component (in kit): A942216; Recalled Supplier Lot Number (in kit): NGKT3375;Quantity: 30Recall no. Z-0101-2027Class II
  11. HEART PREP TRAY; Model/Item Number (Kit): MECV97W;

    Codes/lots: Model/Item Number (Kit): MECV97W; UDI-DI: 10809160493113; Kit Lot Numbers: 1691836, 1696316; Recalled Supplier Component (in kit): A319514AM; Recalled Supplier Lot Number (in kit): NGKV2393;Quantity: 96Recall no. Z-0102-2027Class II
  12. UROLOGY MAJOR; Model/Item Number (Kit): WRNM058-10;

    Codes/lots: Model/Item Number (Kit): WRNM058-10; UDI-DI: 10809160488898; Kit Lot Numbers: 1681989; Recalled Supplier Component (in kit): A902416; Recalled Supplier Lot Number (in kit): NGKU2887;Quantity: 20Recall no. Z-0103-2027Class II
  13. MAJOR PACK; Model/Item Number (Kit): NIHB0018-11;

    Codes/lots: Model/Item Number (Kit): NIHB0018-11; UDI-DI: 10809160403747; Kit Lot Numbers: 1667763; Recalled Supplier Component (in kit): A942216; Recalled Supplier Lot Number (in kit): NGKT3375;Quantity: 40Recall no. Z-0104-2027Class II
  14. GYN LAPAROSCOPY PACK; Model/Item Number (Kit): NAMC436-12;

    Codes/lots: Model/Item Number (Kit): NAMC436-12; UDI-DI: 10809160468470; Kit Lot Numbers: 1697826; Recalled Supplier Component (in kit): A119216M; Recalled Supplier Lot Number (in kit): NGKT3314;Quantity: 28Recall no. Z-0105-2027Class II
  15. ABD HYSTERECTOMY; Model/Item Number (Kit): NAMC438-07;

    Codes/lots: Model/Item Number (Kit): NAMC438-07; UDI-DI: 10809160417645; Kit Lot Numbers: 1675123, 1675125, 1679551; Recalled Supplier Component (in kit): A119216M; Recalled Supplier Lot Number (in kit): NGKT2404;Quantity: 23Recall no. Z-0106-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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