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High RiskFDA
Medtronic Sofamor Danek Usa Inc
Accurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009 GTIN / UPN: 20763000153599 - Product Usage: (ster...
Medical Devices·2,415 affected·Jun 8, 2020
High RiskFDA
Stumptown Coffee Corp
Stumptown Cold Brew Coffee and Chocolate with Oatmilk. Product is TetraPak Prisma Pak aseptic packaging. Keep refrigerated. Net 11 fl. ...
Dairy·900 affected·Jun 5, 2020
High RiskFDA
Marksans Pharma Limited
Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap ...
Oral Drugs·11,279 affected·Jun 5, 2020
RecallFDA
Akorn, Inc.
Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: ...
Oral Drugs·17,424 affected·Jun 5, 2020
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30); b) 60 tablets (NDC: 43063-428-60); c) 90 tablets (NDC: 43063-428-90); d) ...
Oral Drugs·3,703 affected·Jun 5, 2020
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tab...
Oral Drugs·1,969 affected·Jun 5, 2020
High RiskFDA
Orthopediatrics Corp
OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixa...
Medical Implants·11 affected·Jun 5, 2020
High RiskFDA
Medtronic Navigation, Inc.
StealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product Usage: are intended as an aid for precisely locat...
Medical Devices·2 affected·Jun 5, 2020
CriticalFDA
Verathon, Inc.
GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core One...
Medical Devices·437 affected·Jun 5, 2020
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Calibrator
Medical Devices·1,872 affected·Jun 5, 2020
High RiskFDA
Richard Wolf Gmbh
Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure...
Medical Devices·338 affected·Jun 5, 2020
High RiskFDA
Hf Acquisition Co. Llc
STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support d...
Cardiac Devices·2 affected·Jun 5, 2020
RecallCPSC
Online At Simplyearth.com And The Simply Earth Store In Glendale, Wisconsin From September 2016 Through September 2019 For About $12.
Capstone Holdings Recalls Simply Earth Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
Children's Products·2,935 affected·Jun 4, 2020
RecallCPSC
Online At Emoribeauty.com And Amazon.com From September 2017 Through March 2020 For About $7.
Tim Trading Recalls Emori Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)
Children's Products·900 affected·Jun 4, 2020
RecallFDA
Somerset Therapeutics Llc
Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Ma...
Drugs·48,852 affected·Jun 4, 2020
RecallFDA
Somerset Therapeutics Llc
Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Ma...
Drugs·22,788 affected·Jun 4, 2020
High RiskFDA
Avkare Inc.
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 coun...
Oral Drugs·1,586,913 affected·Jun 4, 2020
Medium RiskFDA
Somerset Therapeutics Llc
Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Mad...
Drugs·383,437 affected·Jun 4, 2020
High RiskFDA
Avkare Inc.
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count ...
Oral Drugs·88,545 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needle...
Surgical Devices·193 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX...
Surgical Devices·88 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles ar...
Surgical Devices·48 affected·Jun 4, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
Medical Devices·37,360 affected·Jun 4, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
CareLink SmartSync Device Manager, Model Number 24970A
Medical Devices·2,773 affected·Jun 4, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Azure S DR MRI, Model Number W3DR01
Medical Devices·49,513 affected·Jun 4, 2020
High RiskFDA
Cardinal Health 200, Llc
Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chro...
Medical Devices·3,000 affected·Jun 4, 2020
High RiskFDA
Hf Acquisition Co., Llc
STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, item number 1010300
Medical Devices·5 affected·Jun 4, 2020
High RiskFDA
Hf Acquisition Co., Llc
STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan Nasal spray, item number 1010300
Medical Devices·155 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles...
Surgical Devices·18,440 affected·Jun 4, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
Medical Devices·266,252 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are i...
Surgical Devices·656 affected·Jun 4, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Azure S SR MRI, Model Number W3SR01
Medical Devices·11,953 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needle...
Surgical Devices·79 affected·Jun 4, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
Medical Devices·31,736 affected·Jun 4, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Patient Connector, Model Number 24967
Medical Devices·1,025 affected·Jun 4, 2020
High RiskFDA
Hf Acquisition Co., Llc
STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300
Medical Devices·95 affected·Jun 4, 2020
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
Medical Devices·17,750 affected·Jun 4, 2020
High RiskFDA
Boston Scientific Corporation
Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are in...
Surgical Devices·7,536 affected·Jun 4, 2020
High RiskFDA
Toufayan Bakery, Inc.
TOUFAYAN BAKERIES SMART POCKETS EVERYTHING 6 COUNT NET WT 7.4 OZ. (210 g), UPC 0 7312400792 7. 12 packages per case. Product expiration d...
Frozen Food·10,804 affected·Jun 3, 2020
High RiskFDA
Walker Emulsions Inc
Walker Emulsions Hand Sanitizer (60%), Non-Sterile Solution, Alcohol Antiseptic 60%, 1 Gallon, Topical Solution, Walker Emulsions Inc., 4...
Topical Drugs·0 affected·Jun 3, 2020
High RiskFDA
Yusef Manufacturing Laboratories, Llc
Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradimate 5%, Octinoxate 7.5%, Octisalate 5%) 0.15 Oz Tube, Rocky ...
Drugs·2,558 affected·Jun 3, 2020
High RiskFDA
Walker Emulsions Inc
Walker Hand Sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70%, 32 oz and 16 oz, Topical Solution, Walker Emulsions Inc., 4401 SE J...
Topical Drugs·0 affected·Jun 3, 2020
High RiskFDA
A.p. Deauville, Llc
Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P. Deauville LLC New Brunswick, NJ 08901, NDC 4291...
Drugs·82,800 affected·Jun 3, 2020
High RiskFDA
Coopersurgical, Inc.
COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
Surgical Devices·2,250 affected·Jun 3, 2020
High RiskFDA
Coltene Whaledent Inc
HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rub...
Surgical Devices·7,206 affected·Jun 3, 2020
High RiskFDA
Coltene Whaledent Inc
HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubbe...
Surgical Devices·7,206 affected·Jun 3, 2020
High RiskFDA
Coltene Whaledent Inc
HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubb...
Surgical Devices·7,206 affected·Jun 3, 2020
High RiskFDA
Dufner Instrumente Gmbh
DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical pr...
Surgical Devices·30 affected·Jun 3, 2020