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High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Philips Medical Systems Gmbh, Dmc
CombiDiagnost R90 Software Version R1.0 and R1.1
Diagnostic Devices·322 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Acme Food Sales Inc
O Organics Tahini is 100% organic ground slightly roasted sesame seed paste, packaged in 16oz glass jar with metal screw on/off lid and h...
Food·11,244 affected·Jul 21, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Pr...
Oral Drugs·560,922 affected·Jul 21, 2020
High RiskFDA
Neurovision Medical Products Inc
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Pro...
Respiratory Devices·1,239 affected·Jul 21, 2020
High RiskFDA
Neurovision Medical Products Inc
Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Product Usage: For continuous EMG monito...
Respiratory Devices·3,425 affected·Jul 21, 2020
High RiskFDA
Beyond White Spa Llc D.b.a. Ezywipe Of Amercia
Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.
Medical Devices·18,500,000 affected·Jul 21, 2020
High RiskFDA
Neurovision Medical Products Inc
Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product Usage: For continuous EMG ...
Respiratory Devices·0 affected·Jul 21, 2020
High RiskFDA
Neurovision Medical Products Inc
Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG...
Respiratory Devices·0 affected·Jul 21, 2020
High RiskFDA
Neurovision Medical Products Inc
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - Pro...
Respiratory Devices·1,089 affected·Jul 21, 2020
High RiskFDA
Uncommon Canning Llc
Strongbrew CBD Infused Cold Brew Coffee, 12oz can, KEEP REFRIGERATED, UPC: 71203869615
Beverages·5,754 affected·Jul 20, 2020
High RiskFDA
Uncommon Canning Llc
Strongbrew Cold Brew Coffee, 12oz can, KEEP REFRIGERATED, UPC: 898577002141
Beverages·5,754 affected·Jul 20, 2020
High RiskFDA
Pfizer Inc.
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake F...
Drugs·19,144 affected·Jul 20, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS XT7600 Integrated System, Product code 6844461
Medical Devices·0 affected·Jul 20, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS XT3400 Chemistry System, Product code 6844458
Medical Devices·0 affected·Jul 20, 2020
High RiskFDA
Nobel Biocare Services Ag
NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower ...
Medical Implants·188 affected·Jul 20, 2020
High RiskFDA
Conformis, Inc.
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLA...
Medical Implants·1 affected·Jul 20, 2020
High RiskFDA
Topway Enterprises, Inc
Tuna cut and packaged in Styrofoam case approximately 19 kg per case
Seafood·1,300 affected·Jul 18, 2020
High RiskFDA
Topway Enterprises, Inc
Salmon cut and packaged in Styrofoam case approximately 19 kg per case
Seafood·16,700 affected·Jul 18, 2020
High RiskFDA
Giant Eagle
Giant Eagle Dried Island Fruit Mix , Net Wt. 10 oz. , 6 units per case. Packaging is a gusseted plastic resealable bag. Expiration d...
Produce·18 affected·Jul 17, 2020
High RiskFDA
Lupin Pharmaceuticals Inc.
Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laboratories NDC 68001-334-08
Oral Drugs·11,688 affected·Jul 17, 2020
High RiskFDA
Ion Beam Applications S.a.
Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce ...
Medical Devices·2 affected·Jul 17, 2020
High RiskFDA
Diasorin Inc.
Parvovirus B19 IgG EIA kit Part No. V519IGUS
Medical Devices·615 affected·Jul 17, 2020
High RiskFDA
Medtronic Neuromodulation
Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Medical Devices·2,408 affected·Jul 17, 2020
High RiskFDA
Ortho Clinical Diagnostics
VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For ...
Diagnostic Devices·2,349 affected·Jul 17, 2020
High RiskFDA
J F C International Inc
Kasugai brand Matcha Ame (Green tea candy); 4.58 oz. plastic bag; 2 x 12 individual items per case Product of Japan Ingredients: glu...
Snacks & Candy·4,620 affected·Jul 16, 2020
High RiskFDA
Provident Nutraceutical Div. Of Ortho Molecular Products Inc
Dietary supplements, 60 capsules, UPC 15033-61832, Product # 832060, labeled under the following brands and product names, packaged in ...
Supplements·95 affected·Jul 16, 2020
High RiskFDA
Grato Holdings, Inc.
HGH Vitality Homeopathic, 90 tablets, NDC 43742-1299-1, Dist. by Deseret Biologicals, Inc. 469 W. Parkland Drive, Sandy, UT 84070, NDC: 4...
Oral Drugs·850 affected·Jul 16, 2020
High RiskFDA
Brainlab Ag
BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
Medical Devices·9 affected·Jul 16, 2020
High RiskFDA
Brainlab Ag
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Medical Devices·18 affected·Jul 16, 2020
High RiskFDA
Shanghai United Imaging Healthcare Co., Ltd.
uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals ...
Diagnostic Devices·1 affected·Jul 16, 2020
High RiskFDA
Philips North America, Llc
Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3...
Cardiac Devices·95,212 affected·Jul 16, 2020
High RiskFDA
Happy Colon Foods
Happy Colon MMMM Chocolate Chip Cookie 0.98oz UPC 56817 00703
Bakery & Grains·1,538 affected·Jul 15, 2020
High RiskFDA
Happy Colon Foods
Happy Colon Yum Shortbread Cookie 0.98oz UPC 56817 00704
Bakery & Grains·1,538 affected·Jul 15, 2020
High RiskFDA
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provid...
Medical Devices·6 affected·Jul 15, 2020
High RiskFDA
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US - Product Usage: is used for peripheral neural stimulation to provide...
Medical Devices·1,550 affected·Jul 15, 2020
High RiskFDA
Hager & Meisinger Gmbh
SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8; 2025-03-18 - Product Usage: Cutting of hard struc...
Medical Devices·144 affected·Jul 15, 2020
High RiskFDA
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US and 2. FR4A-RCV-A0 EU - Product Usage: is used for peripheral n...
Medical Devices·13 affected·Jul 15, 2020
High RiskFDA
Sicat Gmbh & Co. Kg
SICAT IMPLANT V2.0
Medical Implants·853 affected·Jul 15, 2020
High RiskFDA
Qiagen Sciences Llc
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and dif...
Respiratory Devices·1,474 affected·Jul 15, 2020
High RiskFDA
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neur...
Medical Devices·2,444 affected·Jul 15, 2020
High RiskFDA
Neurologica Corporation
OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is inte...
Medical Devices·35 affected·Jul 15, 2020
High RiskFDA
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neura...
Medical Devices·1,424 affected·Jul 15, 2020
High RiskFDA
Medtronic Inc.
The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
Medical Devices·3,588 affected·Jul 15, 2020