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High RiskFDA
Boston Scientific Corporation
JAGTOME RX 44-20-260-035 Material Number: M00573040
Medical Devices·3,578 affected·Dec 22, 2021
High RiskFDA
Covidien, Lp
SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Medical Devices·66 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
HYDRATOME RX 49-20MM/260CM Material Number: M00583000
Medical Devices·112 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
DREAMTOME 44-30MM/260CM Material Number: M00584050
Medical Devices·12,067 affected·Dec 22, 2021
High RiskFDA
Synthes (usa) Products Llc
Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" T...
Medical Devices·600 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
JAGTOME RX 39-30-260-025 Material Number: M00573100
Medical Devices·1,447 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
JAGTOME RX 39-20-450-025 Material Number: M00573090
Medical Devices·367 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
Medical Devices·7,115 affected·Dec 22, 2021
High RiskFDA
Avanos Medical, Inc.
MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
Medical Devices·2,652 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
DREAMTOME 49-20MM/260CM Material Number: M00584000
Medical Devices·982 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
DREAMTOME 49-30MM/450CM Material Number: M00584030
Medical Devices·32 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
JAGTOME RX 49-20-260-035 Material Number: M00573000
Medical Devices·101 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
DREAMTOME 44-30MM/450CM Material Number: M00584070
Medical Devices·142 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
Medical Devices·3,330 affected·Dec 22, 2021
High RiskFDA
Oscor Inc.
Destino Twist 14F (also branded as Guidestar 14F)
Medical Devices·549 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
Medical Devices·500 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
HYDRATOME RX 44-20MM/260CM Material Number: M00583040
Medical Devices·7,695 affected·Dec 22, 2021
High RiskFDA
Flexdex Inc.
8mm FlexDex Needle Driver, Product Code FD-335 ND
Medical Devices·273 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
DREAMTOME 49-30MM/260CM Material Number: M00584010
Medical Devices·472 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
Medical Devices·1,811 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
HYDRATOME RX 49-30MM/260CM Material Number: M00583010
Medical Devices·0 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M0057544...
Medical Devices·0 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
JAGTOME RX 44-30-260-035 Material Number: M00573060
Medical Devices·2,209 affected·Dec 22, 2021
High RiskFDA
Ascend Laboratories, Llc
Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Lab...
Oral Drugs·42,698 affected·Dec 21, 2021
High RiskFDA
Ideal Specialty Apothecary, Inc. Dba Ideal Pharmacy
Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union,...
Injectable Drugs·57,994 affected·Dec 21, 2021
High RiskFDA
Howmedica Osteonics Corp.
32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
Medical Devices·8 affected·Dec 21, 2021
High RiskFDA
Medtronic Vascular, Inc.
Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C...
Medical Implants·14,629 affected·Dec 21, 2021
High RiskFDA
Professional Complementary Health Formulas, Llc
Inositol packaged in white plastic bottle with UPC 4065111562 and labeled in part, "***PROFESSIONAL FORMULAS COMPLEMENTARY HEALTH Inosito...
Beverages·40 affected·Dec 20, 2021
High RiskFDA
Professional Complementary Health Formulas, Llc
Vitamin B Complex packaged in white plastic bottle labeled in part, "***PROFESSIONAL FORMULAS COMPLEMENTARY HEALTH Vitamin B Complex DIET...
Baby Food & Formula·299 affected·Dec 20, 2021
High RiskFDA
American Health Packaging
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 4...
Oral Drugs·6,637 affected·Dec 20, 2021
High RiskFDA
Biomerieux Inc
API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. I...
Medical Devices·462 affected·Dec 20, 2021
High RiskFDA
Canon Medical System, Usa, Inc.
Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8...
Medical Devices·8 affected·Dec 20, 2021
High RiskFDA
Aroma Meats Llc
Curry Leaf Hot Pickle packaged in white plastic pouch, net wt. 1/2 KG (500 gms). No UPC. Labeled with Aroma Meats name but has no address.
Meat & Poultry·0 affected·Dec 18, 2021
High RiskFDA
Aroma Meats Llc
Nethili Pickle is packaged in clear plastic pouch and product is visible. Incomplete declaration of net weight only LB showing. No UPC....
Food·0 affected·Dec 18, 2021
High RiskFDA
Aroma Meats Llc
Ginger Pickle (Fresh Allam Avakai) was packaged in white plastic pouch, net wt. 1/2KG (500 grams). No UPC. Some packages have no firm na...
Meat & Poultry·0 affected·Dec 18, 2021
High RiskFDA
Aroma Meats Llc
Jackfruit Mango Pickle (Fresh Panasapottu) was packaged in white plastic pouch, net wt. 1/2KG (500 grams). No UPC. The label is read i...
Produce·0 affected·Dec 18, 2021
High RiskFDA
Aroma Meats Llc
Daliya Split Powder (Putnala Podi), packaged in white plastic pouch, net wt. 1/2 KG (500 gms). No UPC. Labeled with Aroma Meats but has ...
Meat & Poultry·0 affected·Dec 18, 2021
High RiskFDA
Aroma Meats Llc
Mango Ginger Pickle (Fresh Mamidi Allam) was packaged in white plastic pouch, net wt. 1/2 KG (500 grams). No UPC. Labeled with Aroma Meat...
Meat & Poultry·0 affected·Dec 18, 2021
High RiskFDA
Aroma Meats Llc
Curry Leaf Powder (Karevepaku Podi), packaged in white plastic pouch, net wt. 1/4 KG (250 grams). No UPC. Labeled with Aroma Meats but ...
Meat & Poultry·0 affected·Dec 18, 2021
High RiskFDA
Aroma Meats Llc
Fresh Banana Pickle is packaged in clear plastic pouch, net wt. 500 gm (1/2 KG). No UPC. Product is imported from Jampani SRT 252, Opp to...
Food·0 affected·Dec 18, 2021
High RiskFDA
Aroma Meats Llc
Cilantro Sweet Pickles (Kollimini Sweet) is packaged in White plastic pouch. Net wt. 1/2 KG (500grams). No UPC. Labeled with Aroma Meat...
Meat & Poultry·0 affected·Dec 18, 2021
High RiskFDA
Local Fixe Llc
Fresh Flour Tortillas are packaged in a clear Ziploc style plastic bag. The weight per package is 1.323 lbs/600 grams. The label is rea...
Beverages·320 affected·Dec 17, 2021
High RiskFDA
Local Fixe Llc
Dinner Rolls are shaped in rounds and sold frozen. Packaged in clear plastic Ziploc style plastic bags. The weight per package s 1.323 l...
Beverages·219 affected·Dec 17, 2021
High RiskFDA
Local Fixe Llc
Pie Dough are packaged two crusts per pack and sold frozen. They are wrapped in white butcher paper. The weight per package is 1.257 lbs...
Dairy·181 affected·Dec 17, 2021
High RiskFDA
Local Fixe Llc
Soup Noodles are raw pasta cut into assorted rectangle shapes and sold frozen. Product is packaged in clear half quart plastic Ziploc st...
Frozen Food·152 affected·Dec 17, 2021
High RiskFDA
Local Fixe Llc
Squid Ink- Fettucine is raw fresh pasta portioned into 4 ounce portions. Each portion is rolled in a wax deli sheet and bulk packaged in...
Food·456 affected·Dec 17, 2021
High RiskFDA
Local Fixe Llc
Classic Lasagna Pasta sheets sold frozen and wrapped in brown freezer paper. The weight per package is 1 lb/453.6 grams. The label is r...
Beverages·50 affected·Dec 17, 2021
High RiskFDA
Covidien Llc
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. P...
Surgical Devices·1,994 affected·Dec 17, 2021