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High RiskFDA
Doctors Scienfic Organica
Burn Boot Camp AFTERBURN GRASS-FED WHEY PROTEN BAR, TRIPLE CHOCOLATE WITH ALMOND BUTTER, NET WT. 2.12 OZ (60 G), packaged in metalized film.
Dairy·66,960 affected·Nov 3, 2023
High RiskFDA
The Coastal Companies Dba Hearn Kirkwood
Le Croissant Ham & Swiss Net Wt. 5.5oz (156g) UPC:766375261612 Packaged in clamshell container. Sold under Food Unlimited brand.
Food·108 affected·Nov 3, 2023
High RiskFDA
Wilson-cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
Medical Devices·553 affected·Nov 3, 2023
High RiskFDA
Wilson-cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree
Medical Devices·941 affected·Nov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE PVP SOLUTION, REF DYNDA1907
Medical Devices·8,250 affected·Nov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE POVIDONE, REF DYNDA2061
Medical Devices·300 affected·Nov 3, 2023
High RiskFDA
Medtronic Inc.
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Cardiac Devices·64,739 affected·Nov 3, 2023
High RiskFDA
Wilson-cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree
Medical Devices·157 affected·Nov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE BETADINE, REF DYNDA1998
Medical Devices·1,800 affected·Nov 3, 2023
High RiskFDA
Wilson-cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
Medical Devices·731 affected·Nov 3, 2023
High RiskFDA
Liberty Medical Solutions, Llc
Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
Medical Devices·473 affected·Nov 3, 2023
High RiskFDA
Inpeco S.a.
Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analyt...
Medical Devices·1 affected·Nov 3, 2023
High RiskFDA
Wilson-cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree
Medical Devices·888 affected·Nov 3, 2023
High RiskFDA
Wilson-cook Medical Inc.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree
Medical Devices·111 affected·Nov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE PVP, REF DYNDA1649
Medical Devices·700 affected·Nov 3, 2023
High RiskFDA
Medline Industries, Lp - Northfield
STERILE STERILE PREP STICK, REF DYNDA1134
Medical Devices·240 affected·Nov 3, 2023
High RiskFDA
Scoular Grain Co
Milled Brown Flax - MBF9, 50lb bag
Food·40,000 affected·Nov 2, 2023
High RiskFDA
Scoular Grain Co
Milled Golden Flax MGDF, 50 lb bag
Food·10,000 affected·Nov 2, 2023
High RiskFDA
Apotex Corp.
Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60505-0084-2, c)100...
Oral Drugs·25,776 affected·Nov 1, 2023
High RiskFDA
Padagis Us Llc
Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. L...
Oral Drugs·7,032 affected·Nov 1, 2023
High RiskFDA
Apotex Corp.
Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c...
Oral Drugs·34,392 affected·Nov 1, 2023
High RiskFDA
Apotex Corp.
Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#: 60505-0083-4 M...
Oral Drugs·48,623 affected·Nov 1, 2023
High RiskFDA
Apotex Corp.
Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto, Ontario...
Oral Drugs·4,074 affected·Nov 1, 2023
High RiskFDA
Atrium Medical Corporation
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Medical Devices·835 affected·Nov 1, 2023
High RiskFDA
Change Healthcare Canada Company
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Medical Devices·454 affected·Nov 1, 2023
High RiskFDA
Medline Industries, Lp - Northfield
ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
Medical Devices·4,850 affected·Nov 1, 2023
High RiskFDA
Medline Industries, Lp - Northfield
PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561
Medical Devices·1,770 affected·Nov 1, 2023
High RiskFDA
Medline Industries, Lp - Northfield
BLOOD CULTURE KIT, REF DYNDH1647B
Medical Devices·1,890 affected·Nov 1, 2023
High RiskFDA
Turncare, Inc
Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix)
Medical Devices·1,081 affected·Nov 1, 2023
High RiskFDA
Abbott Laboratories
Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
Food·226,650 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
Medical Implants·7,438 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
Medical Implants·126 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
Medical Implants·126 affected·Oct 31, 2023
High RiskFDA
Bioreference Health, Llc
The 4Kscore Test, an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate spec...
Diagnostic Devices·1 affected·Oct 31, 2023
High RiskFDA
Zeus Scientific, Inc.
ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
Medical Devices·293 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
Medical Implants·45 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
Medical Implants·10,287 affected·Oct 31, 2023
High RiskFDA
Pepsi Beverages, Llc
Crush Orange Soda, 24 Pack. 24 - 12 oz. cans. Caffeine Free. Contains No Juice. UPC 0 78000-01309 2. Produced under the Authority of...
Beverages·184 affected·Oct 27, 2023
High RiskFDA
Amneal Pharmaceuticals Of New York, Llc
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC#...
Oral Drugs·9,263 affected·Oct 27, 2023
High RiskFDA
Vyaire Medical
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Respiratory Devices·16 affected·Oct 27, 2023
High RiskFDA
Limacorporate S.p.a
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Medical Devices·33 affected·Oct 27, 2023
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the deter...
Diagnostic Devices·6,035 affected·Oct 26, 2023
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the deter...
Diagnostic Devices·6,611 affected·Oct 26, 2023
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator...
Medical Devices·291 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·264 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·451 affected·Oct 25, 2023
High RiskFDA
Riverpoint Medical, Llc
Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF...
Medical Devices·999 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·47 affected·Oct 25, 2023