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High RiskFDA
Philips North America
ProxiDiagnost N90 R.1.0
Diagnostic Devices·25 affected·Mar 3, 2023
High RiskFDA
Philips North America
CombiDiagnost R90 R.1.0
Diagnostic Devices·25 affected·Mar 3, 2023
High RiskFDA
Access Vascular, Inc
HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
Surgical Devices·240 affected·Mar 3, 2023
High RiskFDA
Philips North America
CombiDiagnost R90 R1.1
Diagnostic Devices·25 affected·Mar 3, 2023
High RiskFDA
Endo Pharmaceuticals, Inc.
Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx onl...
Inhaled / Nasal Drugs·372,938 affected·Mar 2, 2023
High RiskFDA
Breckenridge Pharmaceutical, Inc
Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) ...
Injectable Drugs·0 affected·Mar 2, 2023
High RiskFDA
Breckenridge Pharmaceutical, Inc
Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c) 1,000-count bottle...
Injectable Drugs·0 affected·Mar 2, 2023
High RiskFDA
Breckenridge Pharmaceutical, Inc
Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c)...
Injectable Drugs·0 affected·Mar 2, 2023
High RiskFDA
Breckenridge Pharmaceutical, Inc
Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 51991-0707-05), Rx o...
Injectable Drugs·0 affected·Mar 2, 2023
High RiskFDA
Breckenridge Pharmaceutical, Inc
Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: ...
Injectable Drugs·0 affected·Mar 2, 2023
High RiskFDA
Breckenridge Pharmaceutical, Inc
Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: ...
Injectable Drugs·0 affected·Mar 2, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reorder #CR230K, Sterile.
Medical Devices·162 affected·Mar 2, 2023
High RiskFDA
Stryker Corporation
SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
Medical Devices·5,228 affected·Mar 2, 2023
High RiskFDA
B. Braun Medical Inc
Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc,...
Injectable Drugs·30,672 affected·Mar 1, 2023
High RiskFDA
Apotex Corp.
Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641 5; b) 1...
Ophthalmic Drugs·67,056 affected·Mar 1, 2023
High RiskFDA
Elekta Instrument Ab
Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund...
Surgical Devices·70 affected·Mar 1, 2023
High RiskFDA
Terumo Cardiovascular Systems Corporation
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Respiratory Devices·84 affected·Mar 1, 2023
High RiskFDA
Stryker Corporation
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for us...
Surgical Devices·1,225 affected·Mar 1, 2023
High RiskFDA
Coloplast Manufacturing Us, Llc
Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
Medical Implants·9 affected·Mar 1, 2023
High RiskFDA
Coloplast Manufacturing Us, Llc
Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400; inflatable penile Prosthesis
Medical Implants·0 affected·Mar 1, 2023
High RiskFDA
Stryker Corporation
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS Indicated for ...
Surgical Devices·1,206 affected·Mar 1, 2023
High RiskFDA
Coloplast Manufacturing Us, Llc
Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
Medical Implants·13 affected·Mar 1, 2023
High RiskFDA
Coloplast Manufacturing Us, Llc
Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
Medical Implants·11 affected·Mar 1, 2023
High RiskFDA
Coloplast Manufacturing Us, Llc
Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
Medical Implants·20 affected·Mar 1, 2023
High RiskFDA
Covidien, Lp
Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
Medical Devices·770 affected·Mar 1, 2023
High RiskFDA
Atrium Medical Corporation
Express Mini 500 Dry Seal Chest Drain, Part Number 16400
Medical Devices·8,184 affected·Mar 1, 2023
High RiskFDA
Coloplast Manufacturing Us, Llc
Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
Medical Implants·1 affected·Mar 1, 2023
High RiskFDA
Stryker Corporation
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
Medical Devices·1,730 affected·Mar 1, 2023
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number:...
Medical Devices·47 affected·Mar 1, 2023
High RiskFDA
Coloplast Manufacturing Us, Llc
Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
Medical Implants·15 affected·Mar 1, 2023
High RiskFDA
Stryker Sustainability Solutions
Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30...
Medical Devices·127,894 affected·Mar 1, 2023
High RiskFDA
Terumo Cardiovascular Systems Corporation
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Respiratory Devices·4,940 affected·Mar 1, 2023
High RiskFDA
Coloplast Manufacturing Us, Llc
Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
Medical Implants·2 affected·Mar 1, 2023
High RiskFDA
Terumo Cardiovascular Systems Corporation
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Respiratory Devices·1,412 affected·Mar 1, 2023
High RiskFDA
Coloplast Manufacturing Us, Llc
Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
Medical Implants·20 affected·Mar 1, 2023
High RiskFDA
Covidien, Lp
Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V2...
Medical Devices·36,204 affected·Mar 1, 2023
High RiskFDA
Russell Stover Candies Inc
Russel Stover Sugar Free Peanut Butter Cups packaged in 2.4oz peg bag, containing individually wrapped pieces. UPC 077260096937
Dairy·22,682 affected·Feb 28, 2023
High RiskFDA
4 J's Treats, Llc Dba Bruttles Gourmet Candies
Butter Toffee, net wt. 16 oz, 6 units per case. Label declares: Butter Toffee, Butter, Sugar, Corn Syrup, Almonds, Vanilla, Salt. www.bru...
Dairy·25 affected·Feb 28, 2023
High RiskFDA
Ba Sports Nutrition, Llc
BODYARMOR SportWater 24/700mL; BODYARMOR SportWater 12/1Liter; BODYARMOR SportWater 24/20oz 6PK; BODYARMOR SportWater 2x6/1 Liter; BODYAR...
Beverages·21,000,000 affected·Feb 28, 2023
High RiskFDA
Sagent Pharmaceuticals Inc
Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. fo...
Injectable Drugs·28,875 affected·Feb 28, 2023
High RiskFDA
Omega Medical Imaging, Inc.
Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085
Medical Devices·52 affected·Feb 28, 2023
High RiskFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Medical Devices·391 affected·Feb 28, 2023
High RiskFDA
Insulet Corporation
Omnipod 5 Automated Insulin Delivery System
Diabetes Devices·11,016 affected·Feb 28, 2023
High RiskFDA
Elekta Inc
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Medical Devices·2,020 affected·Feb 28, 2023
High RiskFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 099...
Medical Devices·391 affected·Feb 28, 2023
High RiskFDA
Bio-rad Laboratories, Inc.
BioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack
Diagnostic Devices·932 affected·Feb 28, 2023
High RiskFDA
Kawasho Foods Usa, Inc
Geisha Medium Shrimp; WT 4OZ(113g)
Seafood·1,629 affected·Feb 24, 2023
High RiskFDA
Ecometics, Inc.
Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%), packag...
Topical Drugs·0 affected·Feb 24, 2023