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High RiskFDA
Philips North America Llc
728333 Spectral CT 7500 -Computed Tomography X-ray system
Medical Devices·1 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728332 IQon Spectral CT-Computed Tomography X-ray system
Medical Devices·0 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
Medical Devices·3 affected·Jun 8, 2021
High RiskFDA
Philips North America Llc
728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT Upgrades
Medical Devices·3 affected·Jun 8, 2021
High RiskFDA
Pear Therapeutics, Inc.
reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Medical Devices·3,370 affected·Jun 7, 2021
High RiskFDA
Medtronic Vascular, Inc.
Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166E...
Medical Implants·18 affected·Jun 7, 2021
High RiskFDA
Pear Therapeutics, Inc.
reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
Medical Devices·812 affected·Jun 7, 2021
High RiskFDA
Bomunity Ltd Co
Paximune Dietary Supplement Contains Bovine Proteins that help Promote Health and help Modulate Immunity 2 Fl. Oz. (60ml) packaged in dar...
Supplements·3,540 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
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
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
High RiskFDA
Boston Scientific Corporation
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
Cardiac Devices·6,377 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
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
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
High RiskFDA
Jesmar Spices, Llc
Adobo para Chorizo - Chorizo Marinade - Seasoning for Sausage. Product is packaged in a plastic bucket seal with lid, 5 gallons. No UPC....
Food·2 affected·Jun 1, 2021
High RiskFDA
Viona Pharmaceuticals Inc
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, In...
Oral Drugs·21,240 affected·Jun 1, 2021
High RiskFDA
Ossur Americas
OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101
Medical Devices·10,469 affected·Jun 1, 2021
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medtronic Reveal LINQ LNQ11 / PA96000
Medical Devices·666,210 affected·Jun 1, 2021
High RiskFDA
John B. Sanfilippo & Son Inc.
favorite day peanut butter monster Trail Mix, Product Number 04316. Peanuts, peanut butter chips, raisins, M&M'S peanut butter chocolate...
Dairy·5,877 affected·May 28, 2021
High RiskFDA
The Coca-cola Company
Glaceau Vitaminwater XXX labeled to be Glaceau Vitaminwater Zero Sugar XXX acai-blueberry-pomegranate, 16.9 FL OZ, made for glaceau, Atla...
Beverages·9,638 affected·May 28, 2021
High RiskFDA
John B. Sanfilippo & Son Inc.
favorite day peanut butter chocolate Trail Mix, Product Number 04315. Peanut butter cups, Milk Chocolate-covered cereal squares, peanuts...
Dairy·11,541 affected·May 28, 2021
High RiskFDA
John B. Sanfilippo & Son Inc.
favorite day caramel cashew Trail Mix, Product Number 04312. Milk Chocolate caramel balls, cashews, M&M'S milk chocolate candies and Pea...
Dairy·10,532 affected·May 28, 2021
High RiskFDA
John B. Sanfilippo & Son Inc.
favorite day monster Trail Mix, Product Number 04313. Peanuts, M&M'S Milk Chocolate candies, raisins, milk chocolate chips and Peanut Bu...
Dairy·12,017 affected·May 28, 2021
High RiskFDA
John B. Sanfilippo & Son Inc.
Good & Gather Sweet Cajun Trail Mix, Product Number 04659. with Butter Toffee Peanuts, Spicy Seasoned Peanuts, Cajun Sesame Sticks, Roas...
Dairy·10,521 affected·May 28, 2021
High RiskFDA
Covidien, Lp
Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 33 cm, Item Code 8888541033P
Surgical Devices·0 affected·May 28, 2021