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High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M0...
Medical Devices·0 affected·Oct 21, 2021
High RiskFDA
Amo Manufacturing Usa, Llc
iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studi...
Medical Devices·711 affected·Oct 21, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00...
Medical Devices·0 affected·Oct 21, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00...
Medical Devices·0 affected·Oct 21, 2021
High RiskFDA
Amo Manufacturing Usa, Llc
Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision La...
Medical Devices·546 affected·Oct 21, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
Medical Devices·0 affected·Oct 21, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
Medical Devices·0 affected·Oct 21, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M0054...
Medical Devices·0 affected·Oct 21, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M005...
Medical Devices·0 affected·Oct 21, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedu...
Diagnostic Devices·15 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure ...
Diagnostic Devices·8 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure ...
Diagnostic Devices·15 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure ...
Diagnostic Devices·3 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure...
Diagnostic Devices·8 affected·Oct 20, 2021
High RiskFDA
Biomeme, Inc.
Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; S...
Medical Devices·11,607 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional proced...
Diagnostic Devices·2 affected·Oct 20, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure...
Diagnostic Devices·2 affected·Oct 20, 2021
High RiskFDA
Mountain View Bakery
Mountain View Bakery Chocolate Cake Roll 4oz or 8oz packaged in plastic clamshell sold individually
Bakery & Grains·19 affected·Oct 19, 2021
High RiskFDA
Mountain View Bakery
Mountain View Bakery Peaches and Cr¿me Cake 4oz or 8oz packaged in plastic clamshell sold individually
Bakery & Grains·35 affected·Oct 19, 2021
High RiskFDA
Mountain View Bakery
Mountain View Bakery Apple White Chocolate Bread 4oz or 8oz packaged in plastic clamshell sold individually
Bakery & Grains·70 affected·Oct 19, 2021
High RiskFDA
Teligent Pharma, Inc.
Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 083...
Topical Drugs·5,400 affected·Oct 19, 2021
High RiskFDA
Teligent Pharma, Inc.
Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 083...
Topical Drugs·2,664 affected·Oct 19, 2021
High RiskFDA
Infutronix Llc
Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and ...
Medical Devices·74 affected·Oct 19, 2021
High RiskFDA
Ivar's Commissary
Ivar's Kettle Classic Clam Chowder With Uncured Bacon, Item #1952, Costco Item #1270666. The soup is refrigerated and packaged in 24 oz....
Food·1,871 affected·Oct 18, 2021
High RiskFDA
Drg International, Inc.
Total Thyroxine (T4) ELISA; REF EIA-1781
Medical Devices·314 affected·Oct 18, 2021
High RiskFDA
Roche Diagnostics Operations, Inc.
Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the cobas u 601 ur...
Diabetes Devices·636 affected·Oct 18, 2021
High RiskFDA
Western/scott Fetzer Company
Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602
Medical Devices·40 affected·Oct 16, 2021
High RiskFDA
Western/scott Fetzer Company
Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603
Medical Devices·40 affected·Oct 16, 2021
High RiskFDA
Western/scott Fetzer Company
Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600
Medical Devices·4,974 affected·Oct 16, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, an...
Diagnostic Devices·1,326 affected·Oct 15, 2021
High RiskFDA
Howmedica Osteonics Corp.
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
Medical Devices·0 affected·Oct 15, 2021
High RiskFDA
Medtronic Vascular, Inc.
Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF282...
Medical Implants·511 affected·Oct 15, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, an...
Diagnostic Devices·1,407 affected·Oct 15, 2021
High RiskFDA
Howmedica Osteonics Corp.
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
Medical Devices·0 affected·Oct 15, 2021
High RiskFDA
The Binding Site Group, Ltd.
Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK...
Medical Devices·2,254 affected·Oct 15, 2021
High RiskFDA
Medtronic Vascular, Inc.
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Medical Implants·2 affected·Oct 15, 2021
High RiskFDA
Keurig Dr Pepper
Target Good & Gather Coconut Pineapple Sparkling Water 8 pack of 12 oz. cans UPC can: 0 85239 04059 1, UPC outer carton (8 pack): 0 85239...
Beverages·2,148 affected·Oct 14, 2021
High RiskFDA
Keurig Dr Pepper
7UP Zero Sugar Lemon Lime Soda 12 pack of 12 oz. can UPC Cardboard Wrap Code: 7800001181 UPC Can Code: 0780790
Beverages·9,152 affected·Oct 14, 2021
High RiskFDA
Keurig Dr Pepper
Polar Black Cherry Premium Seltzer 12 pack of 12oz cans UPC Cardboard Wrap Code: 7153700228, UPC Can Code: 7153700110
Food·7,849 affected·Oct 14, 2021
High RiskFDA
Keurig Dr Pepper
Target Good & Gather Mixed Berry Sparkling Water 8 pack of 12 oz. cans UPC can: 0 85239 11516 9, UPC outer Carton (8 pack): 0 85239 11345 5
Beverages·9,393 affected·Oct 14, 2021
High RiskFDA
Golden State Medical Supply Inc.
Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Sh...
Oral Drugs·101 affected·Oct 14, 2021
High RiskFDA
Golden State Medical Supply Inc.
Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, L...
Oral Drugs·49 affected·Oct 14, 2021
High RiskFDA
Biocheck, Inc.
T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determ...
Diagnostic Devices·314 affected·Oct 14, 2021
High RiskFDA
Hill-rom Inc.
These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0...
Medical Devices·1,050 affected·Oct 14, 2021
High RiskFDA
Sedecal Sa
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
Diagnostic Devices·851 affected·Oct 14, 2021
High RiskFDA
Beeken Biomedical, Llc
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Medical Devices·15 affected·Oct 14, 2021
High RiskFDA
Fujifilm Healthcare Americas Corporation
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Medical Devices·38 affected·Oct 14, 2021
High RiskFDA
Fujifilm Healthcare Americas Corporation
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Medical Devices·0 affected·Oct 14, 2021