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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
CriticalFDA
Ducktrap River Of Maine Llc
Ducktrap River of Maine Herring Center Cuts in Wine Sauce, 12 oz.
Food·972 affected·Jan 3, 2020
CriticalFDA
Jeni's Splendid Ice Creams Llc
Jeni's Dairy Free Cold Brew with Coconut Cream Pints frozen dessert
Dairy·49,358 affected·Jan 3, 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
CriticalFDA
Rachael's Food Corporation
Rachael's brand and Big Y brand Protein Snack Packs; containing one hard boiled egg, diced roasted turkey, and roasted almonds; packaged ...
Meat & Poultry·87 affected·Dec 31, 2019
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
CriticalFDA
International Sprout Holding Inc.
Clover seed in 50 lb. woven poly bags, 40 bags to a pallet.
Food·15,750 affected·Dec 30, 2019
High RiskFDA
Savannah Food Company, Inc.
Savannah Classics Classic Bread Stuffing packaged in 4.5lb trays
Bakery & Grains·83 affected·Dec 30, 2019
CriticalFDA
Meijer
Fresh From Meijer diced hard boiled eggs sold by weight from the salad bar area in clear plastic clamshell PLU 8505, UPC 0-0-8505-2
Produce·200 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
CriticalFDA
International Sprout Holding Inc.
Clover seed in 55 lb. multi-layered white paper bags, 40 bags to a pallet.
Food·13,455 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
High RiskFDA
Smith & Nephew, Inc.
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
Medical Devices·82 affected·Dec 30, 2019
High RiskFDA
Philips North America, Llc
MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
Diagnostic Devices·534 affected·Dec 30, 2019
CriticalFDA
Solta Medical Inc
Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; U...
Surgical Devices·4,472 affected·Dec 30, 2019
High RiskFDA
Philips North America, Llc
Poly G Integris H5000, System code 72246
Medical Devices·1 affected·Dec 30, 2019
CriticalFDA
Five Star Gourmet Foods Of Florida
Simply Fresh brand MiniMeals2Go Avocado Toast (6.75 OZ) ready-to-eat snack packs
Snacks & Candy·370 affected·Dec 27, 2019
CriticalFDA
Sun Valley Foods
3.1-oz. packages containing "EGGLANDS BEST HARD-COOKED EGG BACON & CHEDDAR"
Food·31,320 affected·Dec 27, 2019
CriticalFDA
Five Star Gourmet Foods Of Florida
Simply Fresh brand MiniMeals2Go Protein Pack (8.25 OZ) ready-to-eat snack packs
Snacks & Candy·525 affected·Dec 27, 2019
CriticalFDA
Fresh Unlimited Inc
Chef Salad Kit: 8lbs packaged in cardboard box
Produce·6,337 affected·Dec 27, 2019
CriticalFDA
Sun Valley Foods
3.3-oz. packages of "EGGLANDS BEST HARD-COOKED EGG SALAME & PROVOLONE"
Food·30,402 affected·Dec 27, 2019
CriticalFDA
Fresh Unlimited Inc
Cobb Salad Kit: 8lbs packaged in cardboard box
Produce·876 affected·Dec 27, 2019
CriticalFDA
Fresh Unlimited Inc
Garden Salad Kit: 7lbs packaged in cardboard box
Produce·459 affected·Dec 27, 2019
CriticalFDA
Cheesewich Factory
RTE bacon and eggs 3.6 oz package
Food·2,516 affected·Dec 27, 2019