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High RiskFDA
Mylan Pharmaceuticals Inc.
Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
Oral Drugs·31,736 affected·Jan 7, 2020
High RiskFDA
Appco Pharma Llc
Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharm...
Oral Drugs·1,632 affected·Jan 7, 2020
High RiskFDA
Mylan Pharmaceuticals Inc.
Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
Oral Drugs·16,944 affected·Jan 7, 2020
High RiskFDA
Preferred Pharmaceuticals, Inc
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 6...
Oral Drugs·39,172 affected·Jan 7, 2020
High RiskFDA
Preferred Pharmaceuticals, Inc
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388...
Oral Drugs·221,710 affected·Jan 7, 2020
High RiskFDA
Appco Pharma Llc
Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by:...
Oral Drugs·624 affected·Jan 7, 2020
High RiskFDA
Zimmer Biomet, Inc.
THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-4...
Medical Devices·1,662 affected·Jan 7, 2020
High RiskFDA
Palodex Group Oy
Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Medical Devices·4,563 affected·Jan 7, 2020
High RiskFDA
Palodex Group Oy
Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Medical Devices·101 affected·Jan 7, 2020
High RiskFDA
Smiths Medical Asd, Inc.
Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
Medical Devices·127,700 affected·Jan 7, 2020
High RiskFDA
Stryker Corporation
Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
Medical Devices·26,298 affected·Jan 7, 2020
High RiskFDA
Smiths Medical Asd, Inc.
Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
Medical Devices·720,100 affected·Jan 7, 2020
High RiskFDA
Palodex Group Oy
Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
Medical Devices·297 affected·Jan 7, 2020
High RiskFDA
Medline Industries Inc
Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10...
Medical Devices·500 affected·Jan 7, 2020
High RiskFDA
National Food & Beverage, Inc
Razzoo's Creole Sauce 10X4 LBS (1.8KG) Pouches Net Case Weight; 40 LBS STORE FROZEN
Frozen Food·2,833 affected·Jan 6, 2020
High RiskFDA
National Food & Beverage, Inc
Razzoo's Etouffee Sauce 10X4 LBS (1.8KG) Pouches Net Case Weight; 40 LBS STORE FROZEN
Frozen Food·4,103 affected·Jan 6, 2020
High RiskFDA
National Food & Beverage, Inc
Razzoo's Gumbo Base 10X4 LBS (1.8KG) Pouches Net Case Weight; 40 LBS STORE FROZEN
Frozen Food·3,357 affected·Jan 6, 2020
High RiskFDA
H J Harkins Company Inc Dba Pharma Pac
Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Phar...
Oral Drugs·7,212 affected·Jan 6, 2020
High RiskFDA
Medtech Sas
ROSA Brain 3.0 Application-Brain
Medical Devices·47 affected·Jan 6, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lower - Product Usage: The system is in...
Diagnostic Devices·2,149 affected·Jan 6, 2020
High RiskFDA
W. L. Gore & Associates Inc.
GORE¿ EXCLUDER¿ AAA Endoprosthesis
Medical Implants·255,861 affected·Jan 6, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lower - Product Usage: Product Usage: T...
Diagnostic Devices·0 affected·Jan 6, 2020
High RiskFDA
Medtech Sas
ROSA One 3.1 Brain Application
Medical Devices·39 affected·Jan 6, 2020
High RiskFDA
Carestream Health, Inc.
Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for ex...
Diagnostic Devices·79 affected·Jan 6, 2020
High RiskFDA
W. L. Gore & Associates Inc.
GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
Medical Implants·23,212 affected·Jan 6, 2020
High RiskFDA
Roi Cps Llc
Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Numb...
Surgical Devices·412 affected·Jan 3, 2020
High RiskFDA
Bard Peripheral Vascular Inc
Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged individually in sterile pouches, 5 pouches/carton, Single U...
Medical Devices·2,050 affected·Jan 3, 2020
High RiskFDA
Depuy Orthopaedics, Inc.
SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
Medical Devices·140 affected·Jan 3, 2020
High RiskFDA
Microbiologics Inc
Vaginal Verification Panel Ref 8208 Lot 8208-11
Medical Devices·9 affected·Jan 3, 2020
High RiskFDA
Zimmer Surgical Inc
Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889...
Medical Devices·58 affected·Jan 3, 2020
High RiskFDA
Ethicon, Inc.
Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
Surgical Devices·23,688 affected·Jan 3, 2020
High RiskFDA
Purely Elizabeth.
purely elizabeth Chocolate Sea Salt probiotic granola. Net Wt. 8 oz (227g). UPC 55140-00268. Made with organic quinoa, amaranth and ch...
Dairy·3,719 affected·Jan 2, 2020
High RiskFDA
Clinical Diagnostic Solutions, Inc.
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Medical Devices·261 affected·Jan 2, 2020
High RiskFDA
Icu Medical, Inc.
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary ar...
Surgical Devices·235 affected·Jan 2, 2020
High RiskFDA
Icu Medical, Inc.
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary ar...
Surgical Devices·20 affected·Jan 2, 2020
High RiskFDA
Sanity Chocolate
Dark with Browned Ghee is wrapped in a foil and jacketed with black paper. There is a white sticker on the front that says Sanity Chocola...
Dairy·60 affected·Dec 31, 2019
High RiskFDA
Koios Medical, Inc.
Koios DS Breast <series 1.0>. The device is a software application which assists skilled physicians in analyzing breast ultrasound images.
Medical Devices·10 affected·Dec 31, 2019
High RiskFDA
Savannah Food Company, Inc.
Savannah Classics Classic Bread Stuffing packaged in 4.5lb trays
Bakery & Grains·83 affected·Dec 30, 2019
High RiskFDA
Savannah Food Company, Inc.
Morrison's cornbread dressing packaged in 7lb trays
Bakery & Grains·500 affected·Dec 30, 2019
High RiskFDA
Savannah Food Company, Inc.
Morrison's cornbread dressing packaged in 4lb tray
Bakery & Grains·471 affected·Dec 30, 2019
High RiskFDA
Savannah Food Company, Inc.
Piccadilly Cornbread Dressing in 2# trays
Bakery & Grains·2,222 affected·Dec 30, 2019
High RiskFDA
Savannah Food Company, Inc.
Savannah Classics Classic Cornbread Dressing packaged in 7lb trays
Bakery & Grains·6,324 affected·Dec 30, 2019
High RiskFDA
Savannah Food Company, Inc.
Savannah Classics Special Cornbread Dressing packaged in 7lb trays
Bakery & Grains·1,186 affected·Dec 30, 2019
High RiskFDA
Philips North America, Llc
Integris Allura 9, system codes 722018 722021
Medical Devices·20 affected·Dec 30, 2019
High RiskFDA
Philips North America, Llc
Cardio Vascular-Allura Centron, system code 722400
Medical Devices·87 affected·Dec 30, 2019
High RiskFDA
Philips North America, Llc
UroDiagnost Eleva, system code 708033
Diagnostic Devices·4 affected·Dec 30, 2019
High RiskFDA
Philips North America, Llc
OmniDiagnost Eleva System codes 708028 708027
Diagnostic Devices·69 affected·Dec 30, 2019
High RiskFDA
Philips North America, Llc
Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
Medical Devices·70 affected·Dec 30, 2019