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High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX ...
Medical Devices·15,342 affected·Mar 12, 2020
CriticalFDA
Forest Mushroom Food Inc.
Guan's Enoki Mushrooms; Net Weight 200 g - 7.05 oz. UPC: 8 59267007013 Product Number:50130 Product of Korea, Keep refrigerated Di...
Food·2,479 affected·Mar 11, 2020
High RiskFDA
Jubilant Cadista Pharmaceuticals, Inc.
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 ...
Oral Drugs·89,376 affected·Mar 11, 2020
High RiskFDA
Boddingtons Plastics Ltd
Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, ...
Medical Devices·13,202 affected·Mar 11, 2020
High RiskFDA
Biomerieux Inc
The VITEK 2 Gram-positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in-vitro test t...
Medical Devices·1,698 affected·Mar 11, 2020
High RiskFDA
Merit Medical Systems, Inc.
PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
Medical Devices·1,932 affected·Mar 11, 2020
CriticalFDA
Pero Family Farms Company
Pero Family Farms Fresh n' Savory Simple Side Kit Zucchini Spiral Pesto; 11 oz. EXP 2020-03-20. Cooks in 5 Minutes
Food·446 affected·Mar 10, 2020
High RiskFDA
Juanita's Foods Inc.
Juanita's Foods Hot & Spicy Menudo; Picoso; 25 oz.( 1 lb. 9oz.) 709 grams UPC: 70132 00201 Juanita's Foods, Wilmington, CA
Food·100 affected·Mar 10, 2020
High RiskFDA
Matthew 7:25 Inc Dba Thrive Pharmacy
Buprexone Banana cream 6-0.6 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff...
Topical Drugs·71 affected·Mar 10, 2020
High RiskFDA
Matthew 7:25 Inc Dba Thrive Pharmacy
Buprenorphine Black Cherry 2 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff...
Drugs·89 affected·Mar 10, 2020
High RiskFDA
Matthew 7:25 Inc Dba Thrive Pharmacy
Buprenorphine Watermelon 8 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff R...
Drugs·403 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
Medical Devices·150 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090
Medical Devices·20 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093
Medical Devices·13,620 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082
Medical Devices·870 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
Medical Devices·17,980 affected·Mar 10, 2020
High RiskFDA
Northgate Technologies, Inc.
Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary cal...
Medical Devices·298 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
Medical Devices·3,620 affected·Mar 10, 2020
RecallFDA
Ortho Clinical Diagnostics
VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
Diagnostic Devices·3,181 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
Medical Devices·3,100 affected·Mar 10, 2020
High RiskFDA
Dreyers Grand Ice Cream, Inc.
Outshine Fruit Bars - Variety Pack (contains 24 x 5 oz. units) Strawberry, Pineapple, Grape, Tangerine Repack UPC: 041548816678
Produce·92,393 affected·Mar 9, 2020
High RiskFDA
Dreyers Grand Ice Cream, Inc.
Outshine Fruit Bars Pineapple; 6 Fruit Ice Bars; 6x2 5 fl. oz) 14.7 Fl. oz. (435 mL); Package UPC: 041548750958; Case UPC: 1004154...
Produce·24,297 affected·Mar 9, 2020
High RiskFDA
Dreyers Grand Ice Cream, Inc.
Outshine Fruit Bars Strawberry; 6 Fruit Ice Bars; 14.7 Fl. oz. (435 mL) UPC: 041548610047 Case UPC: 10041548610044
Produce·5,204 affected·Mar 9, 2020
High RiskFDA
Mylan Pharmaceuticals Inc.
Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01
Oral Drugs·300 affected·Mar 9, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets ...
Oral Drugs·9,897 affected·Mar 9, 2020
RecallFDA
Lupin Pharmaceuticals Inc.
Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet...
Oral Drugs·1,712 affected·Mar 9, 2020
High RiskFDA
Sun Pharmaceutical Industries, Inc.
Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA,...
Oral Drugs·1,416 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110
Medical Implants·32 affected·Mar 9, 2020
High RiskFDA
Sysmex America, Inc.
The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, sele...
Medical Devices·93 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
Medical Implants·19 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit
Medical Devices·225 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
Medical Devices·1,785 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
Medical Implants·50 affected·Mar 9, 2020
High RiskFDA
Abbott Gmbh & Co. Kg
ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
Diagnostic Devices·7,347 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit
Medical Devices·5,565 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080
Medical Implants·2 affected·Mar 9, 2020
High RiskFDA
Boston Scientific
Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
Medical Implants·57 affected·Mar 9, 2020
CriticalFDA
Hong Bin Foods Llc
Enoki Mushroom; Product of Korea; Net Wt. 7.05 oz., (200 g) UPC: 7 426852 625810 The Enoki is packaged in a clear film, bottom port...
Food·0 affected·Mar 6, 2020
High RiskFDA
Meijer Inc.
Meijer Mixed Nuts with Peanuts & Sea Salt 16 Oz UPC: 7-19283-80863-9
Food·8,200 affected·Mar 6, 2020
High RiskFDA
Dean Foods, Inc.
Baskin Robbins Mint Chocolate Chip, Ice Cream Sandwiches with Mint Ice Cream, Semi-Sweet Chocolate Chips & Chocolate Wafers 4 Pack; 4 3...
Dairy·46,980 affected·Mar 6, 2020
CriticalFDA
Dole Fresh Vegetables Inc
HEB Tuscan Herb Chopped Salad Kit, 12.6 oz. UPC: 0-41220-40989-1
Produce·300 affected·Mar 6, 2020
High RiskFDA
Nostrum Laboratories Inc
Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas...
Oral Drugs·4,722 affected·Mar 6, 2020
High RiskFDA
H J Harkins Company Inc Dba Pharma Pac
Acetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42), c) 45-count bo...
Oral Drugs·11,973 affected·Mar 6, 2020
High RiskFDA
Cardiac Assist, Inc
TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal c...
Cardiac Devices·2 affected·Mar 6, 2020
High RiskFDA
Cardiac Assist, Inc
TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorpor...
Cardiac Devices·15 affected·Mar 6, 2020
High RiskFDA
Cardiac Assist, Inc
TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique a...
Cardiac Devices·10 affected·Mar 6, 2020
High RiskFDA
R82 A/s
Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830
Medical Devices·2,230 affected·Mar 6, 2020
High RiskFDA
Cardiac Assist, Inc
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal ci...
Cardiac Devices·38 affected·Mar 6, 2020