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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
High RiskFDA
Sedecal Sa
Model Number 40KWFXPLUS.889, Mobile X-ray system
Medical Devices·1 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
Medical Devices·1 affected·Jun 10, 2025
High RiskFDA
Ortho-clinical Diagnostics, Inc.
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 So...
Diagnostic Devices·37,429 affected·Jun 10, 2025
High RiskFDA
Ortho-clinical Diagnostics, Inc.
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 So...
Diagnostic Devices·36,005 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Model Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray system
Medical Devices·2 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
SM_40HF_BDC, Mobile X-ray system
Medical Devices·1 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
RADPRO MOBILE, Mobile X-ray system
Medical Devices·24 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
Diagnostic Devices·56 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Model Number 40KWMOBILE3.899, Mobile X-ray system
Medical Devices·1 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Model Number 40KWFXPLUS.005, Mobile X-ray system
Medical Devices·12 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system
Medical Devices·6 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Model Number 40KWFXPLUS.002, Mobile X-ray system
Medical Devices·8 affected·Jun 10, 2025
High RiskFDA
Sedecal Sa
Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system
Medical Devices·5 affected·Jun 10, 2025
High RiskFDA
Gedney Foods Product, Llc
Zinger Pickle products under the following labels: 1. Gedney Zinger Chips, item 18800, 24 fl oz. (1-1/2 Pt) 710mL. UPC 0 41660-00188...
Snacks & Candy·3,520 affected·Jun 9, 2025
High RiskFDA
Gedney Foods Product, Llc
Gedney Ghost Pepper LIL Pickles, item 75802, Net 24 fl oz. (1.5Pts) 710mL. UPC 0 41660-00758 9. Refrigerate after opening. Distribu...
Food·3,520 affected·Jun 9, 2025
High RiskFDA
Gedney Foods Product, Llc
Dill Pickles packaged under the following label: 1. Gedney Whole Pickles, item 15100, Net 32 fl oz. (1Qt)946mL. UPC 0 41660-00151 8. 2....
Food·3,520 affected·Jun 9, 2025
CriticalFDA
Seal The Seasons, Inc
SEAL THE SEASONS FROZEN ORGANIC***BLUEBERRIES NET WT. 32 OZ (907g) NC UPC 8 50476 00647 1; NJ UPC 8 50037 94831 ? DISTRIBUTED BY: Seal th...
Produce·208 affected·Jun 9, 2025
CriticalFDA
Alma Pak International Llc
FROZEN ORGANIC BLUEBERRIES, INGREDIENTS: FROZEN ORGANIC BLUEBERRIES 30# Bulk Blueberries ALMA PAK INTERNATIONAL, LLC 230 Pineview Rd, Alm...
Produce·400 affected·Jun 9, 2025
High RiskFDA
Unfi General Corporate
1. USA OG2 LEEKS
Food·213 affected·Jun 7, 2025
High RiskFDA
Unfi General Corporate
1. ORGANIC OG2 GREEN ONIONS
Produce·213 affected·Jun 7, 2025
High RiskFDA
Unfi General Corporate
1. USA OG2 BNCH CILANTRO
Food·213 affected·Jun 7, 2025
High RiskFDA
Unfi General Corporate
1. USA/MEX OG2 SPINACH
Produce·213 affected·Jun 7, 2025
High RiskFDA
Unfi General Corporate
1. USA OG2 SDLS MINI WTRM
Food·213 affected·Jun 7, 2025
High RiskFDA
Unfi General Corporate
1. CANADA ENGLISH CUCUMBER
Food·213 affected·Jun 7, 2025
High RiskFDA
Unfi General Corporate
1.MEXICO OG2 FENNEL
Food·213 affected·Jun 7, 2025
High RiskFDA
Unfi General Corporate
1.MIGHTIES OG2 KIWI
Food·213 affected·Jun 7, 2025
High RiskFDA
Unfi General Corporate
1. CA CURLY PARLSEY CTN 2. CA ITALIAN PARSLEY 3. USA OG2 ITALN PARSLEY
Food·213 affected·Jun 7, 2025
High RiskFDA
Unfi General Corporate
1. FRESH OG2 BRUSL SPROUTS
Food·0 affected·Jun 7, 2025
High RiskFDA
Unfi General Corporate
1. WLD HRVST OG2 LEMONS
Food·213 affected·Jun 7, 2025
High RiskFDA
Unfi General Corporate
1.USA OG1 RADISH BAG
Food·213 affected·Jun 7, 2025