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CriticalFDA
Lakeview Farms Llc
Smilin' Bob's Key West Style Smoked Fish Dip Original 8 oz and 15.5 oz plastic container 12 per case
Seafood·1,213 affected·Jun 4, 2021
RecallFDA
Dr. Reddy's Laboratories, Inc.
Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 5...
Oral Drugs·5,984 affected·Jun 4, 2021
High RiskFDA
Simpleware Product Group, Synopsys Northern Europe
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating s...
Surgical Devices·4 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Premier - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio...
Medical Devices·100 affected·Jun 4, 2021
High RiskFDA
Simpleware Product Group, Synopsys Northern Europe
Simpleware ScanIP medical software. For transfer of imaging information from a medical scanner to an output file, and for simulating/eva...
Surgical Devices·6 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Artist, Nuclear Magnetic Resonance Imaging System
Medical Devices·562 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Medical Devices·71 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noi...
Medical Devices·585 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
1.5T SIGNA HDxt (HD28) MR System, Nuclear Magnetic Resonance Imaging System
Medical Devices·91 affected·Jun 4, 2021
High RiskFDA
Ge Healthcare, Llc
Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
Medical Devices·40 affected·Jun 4, 2021
CriticalFDA
Baxter Healthcare Corporation
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fluids.
Medical Devices·130,135 affected·Jun 4, 2021
CriticalFDA
Eight Medical International Bv
Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to ra...
Medical Devices·22 affected·Jun 4, 2021
High RiskFDA
Boston Scientific Corporation
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
Cardiac Devices·70,074 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1125
Medical Implants·4,078 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1153
Medical Implants·163 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Outflow Graft, REF MCS1725OG
Cardiac Devices·459 affected·Jun 3, 2021
High RiskFDA
Axonics Modulation Technologies, Inc.
BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476
Medical Devices·2,702 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Accessories, REF MCS1753AK
Cardiac Devices·76 affected·Jun 3, 2021
High RiskFDA
Boston Scientific Corporation
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
Cardiac Devices·6,377 affected·Jun 3, 2021
CriticalFDA
Boston Scientific Corporation
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
Medical Devices·3,634 affected·Jun 3, 2021
High RiskFDA
Boston Scientific Corporation
Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
Cardiac Devices·2,952 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Driveline Extension Cable, REF 100
Cardiac Devices·338 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1103
Medical Implants·647 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1104
Medical Implants·943 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Implant Kit, REF 1104JP
Medical Implants·63 affected·Jun 3, 2021
CriticalFDA
Boston Scientific Corporation
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
Medical Devices·1,707 affected·Jun 3, 2021
CriticalFDA
Boston Scientific Corporation
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
Cardiac Devices·40,224 affected·Jun 3, 2021
High RiskFDA
Browns Granola Company, Llc
O'Brien's Own Gourmet Granola, busy bee's honey & oat, Net Wt. 12 OZ , UPC 6 09132 49667 7; Manufactured and Distributed by O'Brien's Own...
Bakery & Grains·282 affected·Jun 2, 2021
High RiskFDA
Hix Foods, Inc.
Hix Sauces, Buffalo Wing Sauce, Original Spice, Net Wt. 12.5 oz (355g)
Food·340 affected·Jun 2, 2021
CriticalFDA
Savor Brands Llc.
Farro, Fully Cooked Net Wt. 24 lbs, Item # 641901
Food·1,138 affected·Jun 2, 2021
High RiskFDA
Browns Granola Company, Llc
O'Brien's Own Gourmet Granola, blueberry muffin, Net Wt. 12 OZ , UPC 6 09132 49665 3, Manufactured and Distributed by O'Brien's Own Gourm...
Bakery & Grains·282 affected·Jun 2, 2021
High RiskFDA
Browns Granola Company, Llc
O'Brien's Own Gourmet Granola, chocolate peanut butter, Net Wt. 12 OZ , UPC 6 09132 49668 4; Manufactured and Distributed by O'Brien's Ow...
Dairy·282 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301
Medical Devices·0 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
Medical Devices·88 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343
Medical Devices·0 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314
Medical Devices·10 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321
Medical Devices·11 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331
Medical Devices·0 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311
Medical Devices·22 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312
Medical Devices·33 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335
Medical Devices·0 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310
Medical Devices·81 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342
Medical Devices·12 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333
Medical Devices·12 affected·Jun 2, 2021
High RiskFDA
Biomet, Inc.
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315
Medical Devices·7 affected·Jun 2, 2021
CriticalFDA
Banner Smoked Fish Inc.
Banner Smoked Fish Inc. brand Sliced Gravlax (Salmon (fish), Salt, Sugar, Dill, Pepper, Sodium Nitrite)
Seafood·0 affected·Jun 1, 2021
CriticalFDA
Banner Smoked Fish Inc.
Banner Smoked Fish Inc. brand Sliced Gravad Lox (Salmon, Salt, Dill weed, Pepper, Natural Hardwood Smoke, Sodium Nitrite)
Seafood·0 affected·Jun 1, 2021
CriticalFDA
Banner Smoked Fish Inc.
Banner Smoked Fish Inc. brand Cold Smoked Tuna; Ingredients: Tuna, Salt, Sugar, Natural Wood Smoke
Seafood·0 affected·Jun 1, 2021