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All Product Recalls
49,209 recalls (high severity)
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 Devices0 affectedOct 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 Devices711 affectedOct 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 Devices0 affectedOct 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 Devices0 affectedOct 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 Devices546 affectedOct 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 Devices0 affectedOct 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 Devices0 affectedOct 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 Devices0 affectedOct 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 Devices0 affectedOct 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 Devices15 affectedOct 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 Devices8 affectedOct 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 Devices15 affectedOct 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 Devices3 affectedOct 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 Devices8 affectedOct 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 Devices11,607 affectedOct 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 Devices2 affectedOct 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 Devices2 affectedOct 20, 2021
High RiskFDA
Mountain View Bakery
Mountain View Bakery Chocolate Cake Roll 4oz or 8oz packaged in plastic clamshell sold individually
Bakery & Grains19 affectedOct 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 & Grains35 affectedOct 19, 2021
High RiskFDA
Mountain View Bakery
Mountain View Bakery Apple White Chocolate Bread 4oz or 8oz packaged in plastic clamshell sold individually
Bakery & Grains70 affectedOct 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 Drugs5,400 affectedOct 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 Drugs2,664 affectedOct 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 Devices74 affectedOct 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....
Food1,871 affectedOct 18, 2021
High RiskFDA
Drg International, Inc.
Total Thyroxine (T4) ELISA; REF EIA-1781
Medical Devices314 affectedOct 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 Devices636 affectedOct 18, 2021
High RiskFDA
Western/scott Fetzer Company
Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602
Medical Devices40 affectedOct 16, 2021
High RiskFDA
Western/scott Fetzer Company
Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603
Medical Devices40 affectedOct 16, 2021
High RiskFDA
Western/scott Fetzer Company
Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600
Medical Devices4,974 affectedOct 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 Devices1,326 affectedOct 15, 2021
High RiskFDA
Howmedica Osteonics Corp.
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
Medical Devices0 affectedOct 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 Implants511 affectedOct 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 Devices1,407 affectedOct 15, 2021
High RiskFDA
Howmedica Osteonics Corp.
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
Medical Devices0 affectedOct 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 Devices2,254 affectedOct 15, 2021
High RiskFDA
Medtronic Vascular, Inc.
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Medical Implants2 affectedOct 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...
Beverages2,148 affectedOct 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
Beverages9,152 affectedOct 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
Food7,849 affectedOct 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
Beverages9,393 affectedOct 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 Drugs101 affectedOct 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 Drugs49 affectedOct 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 Devices314 affectedOct 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 Devices1,050 affectedOct 14, 2021
High RiskFDA
Sedecal Sa
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
Diagnostic Devices851 affectedOct 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 Devices15 affectedOct 14, 2021
High RiskFDA
Fujifilm Healthcare Americas Corporation
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Medical Devices38 affectedOct 14, 2021
High RiskFDA
Fujifilm Healthcare Americas Corporation
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Medical Devices0 affectedOct 14, 2021