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High RiskFDA
Sanofi-aventis U.s. Llc
Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A S...
Injectable Drugs·51,325 affected·Apr 11, 2023
High RiskFDA
Bard Peripheral Vascular Inc
Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
Medical Devices·4,120 affected·Apr 11, 2023
High RiskFDA
Dibe Llc
TETAS Mireya, SABOR Nutella
Food·250 affected·Apr 10, 2023
High RiskFDA
Dibe Llc
TETAS Mireya, SABOR Toddy
Food·250 affected·Apr 10, 2023
High RiskFDA
Shimadzu Corporation Medical Systems Division
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpe...
Medical Devices·1,836 affected·Apr 10, 2023
High RiskFDA
Wright Medical Technology, Inc.
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
Medical Devices·50 affected·Apr 10, 2023
High RiskFDA
Wright Medical Technology, Inc.
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
Medical Devices·41 affected·Apr 10, 2023
High RiskFDA
Cargill Cocoa & Chocolate, Inc.
Wilbur¿ Dark Chocolate Covered Cashews Net Wt.16 oz (1 LB) 454g Packaged in plastic bag
Snacks & Candy·17 affected·Apr 7, 2023
High RiskFDA
Give & Go Prepared Foods
H-E-B Bakery Two-Bite Brownies Net Wt. 12 Oz (340g) UPC 041220109517 packaged in a clear clam shell plastic container
Food·3,607 affected·Apr 7, 2023
High RiskFDA
Methapharm Inc
Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral ...
Injectable Drugs·5,377 affected·Apr 7, 2023
High RiskFDA
Gilman Cheese Corporation
0.6 oz. jalapeno cheese sticks. P.6LGSTICKJL. Cheese sticks are packed in clear plastic pouches with a nitrogen flush. Pouches contain ...
Dairy·128,514 affected·Apr 6, 2023
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127...
Drugs·186 affected·Apr 6, 2023
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Inco...
Drugs·352 affected·Apr 6, 2023
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, O...
Drugs·37 affected·Apr 6, 2023
High RiskFDA
Pharma Nobis Llc
Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc....
Drugs·69,615 affected·Apr 6, 2023
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
Simvastatin USP 20 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK...
Drugs·520 affected·Apr 6, 2023
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
Simvastatin USP 40 mg, Rx only, Intas Pharm. Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK...
Drugs·393 affected·Apr 6, 2023
High RiskFDA
3m Company - Health Care Business
3M Attest Steam Chemical Integrators, REF 1243B
Medical Devices·2,235,000 affected·Apr 6, 2023
High RiskFDA
Karl Storz Endoscopy
Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, REF: 11580C; Me...
Medical Devices·4,933 affected·Apr 6, 2023
High RiskFDA
Cardinal Health 200, Llc
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Medical Devices·5 affected·Apr 6, 2023
High RiskFDA
Paximadi Co Llc
Baklava, 2 oz. Each cardboard box contains 25 units (net wt. 50 oz). No UPC. The Ingredients statement declares: Fillo (Enriched, Non-Bro...
Dairy·1 affected·Apr 5, 2023
High RiskFDA
Beckman Coulter, Inc.
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
Diagnostic Devices·355 affected·Apr 5, 2023
High RiskFDA
Boston Scientific Corporation
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Medical Devices·1,300 affected·Apr 5, 2023
High RiskFDA
Illumina, Inc.
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Medical Devices·740 affected·Apr 5, 2023
High RiskFDA
Boston Scientific Corporation
WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
Medical Devices·10,833 affected·Apr 5, 2023
High RiskFDA
Beckman Coulter, Inc.
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700...
Diagnostic Devices·1,068 affected·Apr 5, 2023
High RiskFDA
Smiths Medical Asd Inc.
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breat...
Medical Devices·47,007 affected·Apr 5, 2023
High RiskFDA
Beckman Coulter, Inc.
UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
Diagnostic Devices·306 affected·Apr 5, 2023
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
Medical Devices·48,633 affected·Apr 5, 2023
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibratin...
Diagnostic Devices·6,546 affected·Apr 5, 2023
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
Medical Devices·48,633 affected·Apr 5, 2023
High RiskFDA
Karl Storz Endoscopy
KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Medical Devices·4,386 affected·Apr 5, 2023
High RiskFDA
Illumina, Inc.
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Medical Devices·1,067 affected·Apr 5, 2023
High RiskFDA
Carefusion 303, Inc.
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Medical Devices·622 affected·Apr 5, 2023
High RiskFDA
Smiths Medical Asd Inc.
DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with b...
Medical Devices·14,941 affected·Apr 5, 2023
High RiskFDA
White Castle System
White Castle Chicken Slider Individual sandwiches packaged as two sandwiches - 16 packages per case Unit Size 5.68oz/161g
Meat & Poultry·785 affected·Apr 4, 2023
High RiskFDA
Albertsons Companies Llc
Signature Select Nuts & Grain Bread NET WT 20 OZ (1 LB 8 OZ) 680 g Ingredients: Unbleached enriched wheat flour (wheat flour, malted barl...
Bakery & Grains·1,976,142 affected·Apr 4, 2023
High RiskFDA
Datascope Corp.
MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
Medical Devices·54 affected·Apr 4, 2023
High RiskFDA
E S Foods
61247 Pop-Tart Fudge BB
Food·1,044,918 affected·Apr 3, 2023
High RiskFDA
E S Foods
61114 RS Trix BB
Food·1,044,918 affected·Apr 3, 2023
High RiskFDA
E S Foods
61520 Cheese Stick with 2 Grains and 1 Cup Fruit MB
Dairy·1,044,918 affected·Apr 3, 2023
High RiskFDA
E S Foods
61490 Cheese Cup with 2 Grains MB (meal box)
Dairy·1,044,918 affected·Apr 3, 2023
High RiskFDA
E S Foods
61237 Nutri-Grain Bar, Strawberry BB
Produce·1,044,918 affected·Apr 3, 2023
High RiskFDA
E S Foods
61118C Apple Jacks BB
Food·1,044,918 affected·Apr 3, 2023
High RiskFDA
E S Foods
61288 Mini Animal Graham Cinnamon SB
Food·1,044,918 affected·Apr 3, 2023
High RiskFDA
E S Foods
61152 Smart Choice Chocolate Chip Muffin TSMB
Snacks & Candy·1,044,918 affected·Apr 3, 2023
High RiskFDA
Hiland Dairy Foods Company Llc
Hiland Fat Free Chocolate Milk Vitamin A&D Naturally Flavored Half Pint (236 mL) UPC 72060 00133 4 packaged in a paper carton
Dairy·301,800 affected·Apr 3, 2023
High RiskFDA
E S Foods
61498 Cheese Stick with Marinara Sauce with 2 Grains MB
Dairy·1,044,918 affected·Apr 3, 2023