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High RiskFDA
Avid Medical, Inc.
DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.
Medical Devices·626 affected·Jun 11, 2025
High RiskFDA
Avid Medical, Inc.
PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.
Medical Devices·46 affected·Jun 11, 2025
High RiskFDA
Avid Medical, Inc.
LAPAROSCOPIC GYN. Medical convenience kit.
Medical Devices·18 affected·Jun 11, 2025
High RiskFDA
Recordati Rare Diseases Inc.
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solut...
Medical Devices·3,754 affected·Jun 11, 2025
High RiskFDA
Avid Medical, Inc.
LAPAROSCOPIC TRAY. Medical convenience kit.
Medical Devices·40 affected·Jun 11, 2025
High RiskFDA
Avid Medical, Inc.
ROBOTIC URO/GYN PACK. Medical convenience kit.
Medical Devices·372 affected·Jun 11, 2025
High RiskFDA
Avid Medical, Inc.
GYN LAPAROSCOPY PACK. Medical convenience kit.
Medical Devices·346 affected·Jun 11, 2025
High RiskFDA
Avid Medical, Inc.
ROBOTIC PROSTATECTOMY PACK. Medical convenience kit.
Medical Devices·24 affected·Jun 11, 2025
High RiskFDA
Avid Medical, Inc.
GENERAL LAPAROSCOPY TRAY. Medical convenience kit.
Medical Devices·574 affected·Jun 11, 2025
High RiskFDA
Avid Medical, Inc.
GEN LAPAROSCOPY PACK. Medical convenience kit.
Medical Devices·321 affected·Jun 11, 2025
High RiskFDA
Avid Medical, Inc.
LAPAROSCOPY PACK. Medical convenience kit.
Medical Devices·452 affected·Jun 11, 2025
High RiskFDA
Coopersurgical, Inc.
Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
Medical Devices·475 affected·Jun 11, 2025
High RiskFDA
Avid Medical, Inc.
MAJOR THORACOSCOPY BASIN. Medical convenience kit.
Medical Devices·128 affected·Jun 11, 2025
High RiskFDA
Avid Medical, Inc.
PARTIAL NEPHRECTOMY PACK. Medical convenience kit.
Medical Devices·52 affected·Jun 11, 2025
High RiskFDA
Fujifilm Healthcare Americas Corporation
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Optio...
Medical Devices·293 affected·Jun 11, 2025
High RiskFDA
Turkeyfoot Creek Creamery Llc
Turkeyfoot Creek Creamery Cacao Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid
Dairy·0 affected·Jun 10, 2025
High RiskFDA
Turkeyfoot Creek Creamery Llc
Turkeyfoot Creek Creamery Avalanche Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid
Dairy·0 affected·Jun 10, 2025
High RiskFDA
Turkeyfoot Creek Creamery Llc
Turkeyfoot Creek Creamery Chocolate Peanut Butter Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with pape...
Dairy·0 affected·Jun 10, 2025
High RiskFDA
Turkeyfoot Creek Creamery Llc
Turkeyfoot Creek Creamery Cacao Brownie Bites Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid
Dairy·0 affected·Jun 10, 2025
High RiskFDA
Yerba Prima Inc
Great Plains Bentonite + Herbal Detox Capsules 60 capsules, packaged in PETE amber bottle, white plastic cap and tamper proof seal. Case...
Food·4,985 affected·Jun 10, 2025
High RiskFDA
Turkeyfoot Creek Creamery Llc
Turkeyfoot Creek Creamery Cacao Strawberry Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid
Dairy·0 affected·Jun 10, 2025
High RiskFDA
Turkeyfoot Creek Creamery Llc
Turkeyfoot Creek Creamery Cookies and Cream Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid
Dairy·0 affected·Jun 10, 2025
High RiskFDA
Big O' Smokehouse, Inc.
Big O' Smokehouse 4lb Whitefish Spread Big O' Smokehouse 8oz Whitefish Spread Packaged in plastic containers
Seafood·938 affected·Jun 10, 2025
High RiskFDA
Turkeyfoot Creek Creamery Llc
Turkeyfoot Creek Creamery Mocha Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid
Dairy·0 affected·Jun 10, 2025
High RiskFDA
Turkeyfoot Creek Creamery Llc
Turkeyfoot Creek Creamery Cookie Dough Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid
Dairy·0 affected·Jun 10, 2025
High RiskFDA
Immunocore, Llc
KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limi...
Injectable Drugs·7,572 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
Diagnostic Devices·1,198 affected·Jun 10, 2025
High RiskFDA
Boston Foundation For Sight
BostonSight SCLERAL Lens
Medical Devices·441 affected·Jun 10, 2025
High RiskFDA
Boston Foundation For Sight
BostonSight PROSE Lens.
Medical Devices·38 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
Medical Devices·8 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Model Number 40KWFXPLUS.004, Mobile X-ray system
Medical Devices·3 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Model Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray system
Medical Devices·4 affected·Jun 10, 2025
High RiskFDA
Boston Scientific Corporation
Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Use...
Cardiac Devices·14,724 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system
Medical Devices·142 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
Medical Devices·181 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
SM_40HF_B_D_VIR3, Mobile X-ray system
Medical Devices·17 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
SM_40HF_BDC3, Mobile X-ray system
Medical Devices·1 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Model Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray system
Medical Devices·1 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
SHIMADZU RF.004, Mobile X-ray system
Medical Devices·0 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system
Medical Devices·6 affected·Jun 10, 2025
High RiskFDA
Boston Scientific Corporation
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/4...
Medical Devices·14,724 affected·Jun 10, 2025
High RiskFDA
Boston Scientific Corporation
VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and co...
Cardiac Devices·14,724 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Model Number 40KW-FX.899, Mobile X-ray system
Medical Devices·1 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system
Medical Devices·7 affected·Jun 10, 2025
High RiskFDA
Boston Scientific Corporation
VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 4...
Cardiac Devices·14,724 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system
Medical Devices·6 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system
Medical Devices·6 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
SM_40HF_B_D_VIR3.004, Mobile X-ray system
Medical Devices·3 affected·Jun 10, 2025