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All Product Recalls

68,659 recalls from FDA

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.,...
Oral Drugs·141,995 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., ...
Oral Drugs·109,314 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-...
Oral Drugs·19,352 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 265...
Oral Drugs·160,300 affected·Dec 4, 2018
High RiskFDA
Mylan Laboratories Limited, (nashik Fdf)
Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.,...
Oral Drugs·84,066 affected·Dec 4, 2018
High RiskFDA
Randox Laboratories Ltd.
Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
Diagnostic Devices·225 affected·Dec 4, 2018
High RiskFDA
Agfa-gevaert, N.v.
DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system u...
Medical Devices·10 affected·Dec 4, 2018
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology information system used to manage workflows for treatment pla...
Medical Devices·551 affected·Dec 4, 2018
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients w...
Medical Devices·31 affected·Dec 4, 2018
CriticalFDA
Hiland Dairy Foods Company Llc
Hiland Chocolate Milk, 1/2 gallon (1.89 L). Hiland Dairy Springfield, MO 65803
Dairy·1,151 affected·Dec 3, 2018
High RiskFDA
Conformis, Inc.
iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Pro...
Medical Implants·2 affected·Dec 3, 2018
High RiskFDA
Pentax Of America Inc
Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System ...
Surgical Devices·157 affected·Dec 3, 2018
High RiskFDA
Randox Laboratories Ltd.
Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay o...
Diagnostic Devices·133 affected·Dec 3, 2018
High RiskFDA
Pentax Of America Inc
C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used ...
Surgical Devices·45 affected·Dec 3, 2018
High RiskFDA
Philips Medical Systems Nederlands
Ingenia Elition S, Ingenia Elition X
Medical Devices·35 affected·Dec 3, 2018
High RiskFDA
Randox Laboratories Ltd.
Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay o...
Diagnostic Devices·85 affected·Dec 3, 2018
High RiskFDA
Pentax Of America Inc
Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is i...
Surgical Devices·68 affected·Dec 3, 2018
High RiskFDA
Pentax Of America Inc
Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation Sys...
Surgical Devices·4 affected·Dec 3, 2018
High RiskFDA
Randox Laboratories Ltd.
Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay o...
Diagnostic Devices·141 affected·Dec 3, 2018
CriticalFDA
K & T Oriental Imports Inc.
Salmon fillets packaged inside Styrofoam boxes fully surrounded and covered in ice, which were stored inside a temperature controlled cooler
Seafood·3,094 affected·Nov 30, 2018
RecallFDA
Aurobindo Pharma Usa Inc.
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princet...
Oral Drugs·4,464 affected·Nov 30, 2018
High RiskFDA
Vistapharm, Inc.
NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 ...
Oral Drugs·4,065,550 affected·Nov 30, 2018
High RiskFDA
Tosoh Bioscience Inc
ST AIA-PACK ACTH (ACTH: Adrenocorticotropic Hormone) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Adr...
Diagnostic Devices·1,085 affected·Nov 30, 2018
High RiskFDA
Tosoh Bioscience Inc
AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA...
Diagnostic Devices·19,366 affected·Nov 30, 2018
High RiskFDA
Philips Medical Systems Nederlands
Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
Medical Devices·229 affected·Nov 30, 2018
High RiskFDA
Tosoh Bioscience Inc
ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human ser...
Diagnostic Devices·992 affected·Nov 30, 2018
High RiskFDA
Tosoh Bioscience Inc
ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human ser...
Diagnostic Devices·26,745 affected·Nov 30, 2018
High RiskFDA
Tosoh Bioscience Inc
ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiod...
Diagnostic Devices·24,083 affected·Nov 30, 2018
High RiskFDA
Ge Healthcare, Llc
System, Tomography Computed Emmission
Medical Devices·526 affected·Nov 30, 2018
High RiskFDA
Tosoh Bioscience Inc
AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human se...
Diagnostic Devices·29,645 affected·Nov 30, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and ...
Medical Devices·171 affected·Nov 30, 2018
CriticalFDA
Advanced Pharma Inc.
Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10mL Injectable Solution, 1 mg/10 mL incorrectly labeled as (10 mcg per mL), 1...
Injectable Drugs·225 affected·Nov 29, 2018
High RiskFDA
Omnilife Science Inc.
OMNI K1 Broach Handle, Product Code HS-10054
Medical Devices·7 affected·Nov 29, 2018
High RiskFDA
Ortho Clinical Diagnostics Inc
Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS...
Diagnostic Devices·4,030 affected·Nov 29, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis Vibe System, Model Number 11007642, with software version VD10B.
Medical Devices·1 affected·Nov 29, 2018
High RiskFDA
Frutarom Usa Inc.
Sebastiano's Naturally Flavored Gourmet Syrups Hazelnut 25.4 fl oz (750 ml)
Food·17,274 affected·Nov 28, 2018
RecallFDA
Boston Scientific Corporation
IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiof...
Cardiac Devices·1,282 affected·Nov 28, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Im...
Medical Implants·232 affected·Nov 28, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Im...
Medical Implants·274 affected·Nov 28, 2018
High RiskFDA
Howmedica Osteonics Corp.
Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLI...
Medical Implants·28,461 affected·Nov 28, 2018
High RiskFDA
Zimmer Biomet, Inc.
Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Intended to carry implants and instruments ...
Medical Implants·971 affected·Nov 28, 2018
RecallFDA
Boston Scientific Corporation
Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofr...
Cardiac Devices·1,282 affected·Nov 28, 2018
RecallFDA
Boston Scientific Corporation
IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiof...
Cardiac Devices·1,282 affected·Nov 28, 2018
High RiskFDA
Gemini Food Corporation Inc
Imperial Taste Fried Garlic, Tu Phi; 24 x 8oz. Item #1763 UPC Code: 741861017638; 24 x 12oz. Item #1762 UPC Code: 741861017621 Ing...
Food·715 affected·Nov 27, 2018
CriticalFDA
Kwik Trip, Inc.
Kitchen Cravings Strawberry Parfait, Net Wt 8.25 oz (234g) Creamy Parfait Base, Strawberries with Sweetened Granola. Keep Refrigerated....
Bakery & Grains·45,708 affected·Nov 27, 2018
High RiskFDA
Gemini Food Corporation Inc
Imperial Taste Fried Red Onion, Cu Hanh Phi; 24 x 8oz. Item #1760, UPC Code: 741861017607; 24 x 12oz. Item #1761, UPC Code: 74186101...
Produce·581 affected·Nov 27, 2018
CriticalFDA
Oakhouse Bakery
Kwik Trip Granola, Bulk Granola, 09976. Net Wt 20 lbs / 9.1 kg. Manufactured by: Oakhouse Bakery, 2221 Mustang Way, Madison, WI 53718.
Bakery & Grains·8,300 affected·Nov 27, 2018
CriticalFDA
Sprout Creek Farm, Inc.
Sprout Creek Farm Kinkead raw cows' milk cheese semi-firm savory brothy. The product is packaged with an orange label.
Dairy·4 affected·Nov 27, 2018