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All Product Recalls

49,195 recalls from FDA (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Breckenridge Pharmaceutical, Inc
Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC 51991-894-90), Dis...
Oral Drugs·11 affected·Jan 24, 2020
High RiskFDA
Breckenridge Pharmaceutical, Inc
Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33) and b) 90-count bottles (NDC 51991-893-90) Distrib...
Oral Drugs·11,250 affected·Jan 24, 2020
High RiskFDA
Abbott Gmbh & Co. Kg
LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity ...
Medical Devices·2,676 affected·Jan 24, 2020
High RiskFDA
Ardent Mills Llc
Kroger Unbleached All Purpose Enriched Flour, 5 lb. bag. Bar code: 011110861660
Food·780 affected·Jan 23, 2020
High RiskFDA
Compania Nacional De Chocolates Dcr S.a.
Granuts BBQ Mix, Net Wt/Cont. Neto 16.93 oz (480g), Contains 12 units x 1.41 oz (40g) ea. and Net Wt/Cont. Neto 6.35 oz (180g)
Food·6 affected·Jan 22, 2020
High RiskFDA
Biofire Diagnostics, Llc
FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle ...
Diagnostic Devices·18,501 affected·Jan 22, 2020
High RiskFDA
St Jude Medical, Cardiac Rhythm Management Division
Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 ...
Cardiac Devices·256 affected·Jan 22, 2020
High RiskFDA
Braemar Manufacturing, Llc
Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
Medical Devices·10,582 affected·Jan 22, 2020
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part n...
Medical Devices·16,700 affected·Jan 22, 2020
High RiskFDA
Medline Industries Inc
Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
Medical Devices·122 affected·Jan 21, 2020
High RiskFDA
Hologic, Inc.
Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
Medical Devices·72 affected·Jan 21, 2020
High RiskFDA
Aesculap Implant Systems Llc
Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN...
Medical Implants·24,010 affected·Jan 21, 2020
High RiskFDA
Aesculap Implant Systems Llc
COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos. NN469K NN470K NN471K NN472K NN473K NN474K N...
Medical Implants·0 affected·Jan 21, 2020
High RiskFDA
Aesculap Implant Systems Llc
COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos. NN081K NN082K NN083K NN084K NN085K NN086K N...
Medical Implants·0 affected·Jan 21, 2020
High RiskFDA
Polymer Technology Systems, Inc.
PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantit...
Diagnostic Devices·6,790 affected·Jan 21, 2020
High RiskFDA
Aesculap Implant Systems Llc
AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos. NN058Z NN070Z NN071Z NN072Z NN073Z NN074Z ...
Medical Implants·0 affected·Jan 21, 2020
High RiskFDA
Carolina Liquid Chemistries Corp
Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
Diagnostic Devices·90 affected·Jan 20, 2020
High RiskFDA
T.a.g. Medical Products Corporation, Ltd.
FlipCutter III Drill
Medical Devices·6,625 affected·Jan 20, 2020
High RiskFDA
Ehob, Inc.
Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product...
Medical Devices·0 affected·Jan 19, 2020
High RiskFDA
Tres Coronas Bakery
Flour Tortillas are packaged in clear plastic bags, 12 count per bag and sold under brands Red Apple. Product is also sold under Tres Co...
Beverages·36 affected·Jan 17, 2020
High RiskFDA
H.l. Foodservice, Inc. Dba H.l. Foods Co.
Ground Ginger in clear plastic bags; Sold in 1 lb. and 5 lb. bags Country of Origin: India 1 lb. UPC: 0 00000 94641 4 5 lb. UPC: 0 ...
Food·620 affected·Jan 17, 2020
High RiskFDA
Kentec Medical, Inc
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-80P-50 (8 fr. 50...
Medical Devices·2,130 affected·Jan 17, 2020
High RiskFDA
Ormco/sybronendo
SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
Medical Devices·3,632,493 affected·Jan 17, 2020
High RiskFDA
Kentec Medical, Inc
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-50 (6 fr. 5...
Medical Devices·4,710 affected·Jan 17, 2020
High RiskFDA
Beckman Coulter Inc.
LabPro Data Management System, UDI: 15099590676872 - Product Usage: The LabPro Data Management System is a Microsoft Windows based softwa...
Medical Devices·177 affected·Jan 17, 2020
High RiskFDA
Covidien Llc
Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
Medical Devices·2,180 affected·Jan 17, 2020
High RiskFDA
Kentec Medical, Inc
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-40P-50 (4 fr. 50...
Medical Devices·480 affected·Jan 17, 2020
High RiskFDA
Kentec Medical, Inc
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-50P-50 (5 fr. 50...
Medical Devices·2,850 affected·Jan 17, 2020
High RiskFDA
Kentec Medical, Inc
Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y50P-80 (5 fr. 8...
Medical Devices·70 affected·Jan 17, 2020
High RiskFDA
Ormco/sybronendo
SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
Medical Devices·3,632,493 affected·Jan 17, 2020
High RiskFDA
Shandex Personal Care Manufacturing Inc.
Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot Road,...
Drugs·20,448 affected·Jan 16, 2020
High RiskFDA
Kindroot Llc
kindroot adaptogems; Peach Blossom Plant lozenges for lit looks. 20 lozenges net wt. 2.6 oz. 74 g - Dietary Supplement UPC: 8 60...
Produce·39 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Ph...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/30MG/1MG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 ...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [10ML] 7MG/ML INJ SUSP, For ...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 100 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 1...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Selenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. S...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Ax...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrigerate, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Alprostadil (prostaglandin E1) 80 MCG/ML Injectable, For Intracavernosal Use, Freeze, 2.5 mL Multi-dose Vial, Rx only, Axia Pharmaceutica...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Glycine Injection,GLYCINE USP 50MG/ML INJECTABLE, For IV, IM Use,30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/50MG/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx on...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use, 10 mL Multi-dose...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/ML INJECTABLE, For IM Use, Refrigerate, Protect From Light, 3...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection, 60 mcg/30 mg/2 mg/0.15mg/ml, For Intracavernosal U...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE, For ocular injection, Preservative free, discard unused portion...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40 MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single ...
Injectable Drugs·0 affected·Jan 15, 2020
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2ML] 200MG/2.5MG/ML INJECTABLE, For IM Use, 2 mL Multi-dose...
Injectable Drugs·0 affected·Jan 15, 2020