Skip to main content
High RiskFDA
Quidel Corporation
Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with...
Diagnostic Devices·10,537 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support t...
Respiratory Devices·88 affected·Sep 17, 2020
High RiskFDA
Ge Healthcare, Llc
Flow Sensor Service Part, Catalog 2096513-001-S
Medical Devices·2 affected·Sep 17, 2020
High RiskFDA
Calvin Scott & Company, Inc.
Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia...
Oral Drugs·0 affected·Sep 16, 2020
High RiskFDA
Calvin Scott & Company, Inc.
Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, ...
Oral Drugs·0 affected·Sep 16, 2020
High RiskFDA
Perrigo Company Plc
Albuterol Sulfate Inhalation Aerosol, 90 mcg per actuation, 200 metered inhalations, Manufactured by: Catalent Pharma Solutions, 160 N Ph...
Drugs·7,775,813 affected·Sep 16, 2020
High RiskFDA
Calvin Scott & Company, Inc.
Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia...
Oral Drugs·0 affected·Sep 16, 2020
High RiskFDA
Merit Medical Systems, Inc.
MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)0088445...
Medical Devices·3,385,442 affected·Sep 16, 2020
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)00884450...
Medical Devices·159,396 affected·Sep 16, 2020
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit...
Medical Devices·371,528 affected·Sep 16, 2020
High RiskFDA
Medline Industries Inc
Quick Release Gait Belt, 60
Medical Devices·13,500 affected·Sep 15, 2020
High RiskFDA
3m Company - Health Care Business
3M Red Dot Monitoring Electrode with Foam Tape - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 50...
Medical Devices·10,145,050 affected·Sep 15, 2020
High RiskFDA
Becton Dickinson & Company
BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are int...
Surgical Devices·12,020 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits c...
Medical Devices·80 affected·Sep 14, 2020
High RiskFDA
Becton Dickinson & Company
Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, b...
Medical Devices·72 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist ...
Cardiac Devices·60 affected·Sep 14, 2020
High RiskFDA
Philips North America, Llc
Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used...
Cardiac Devices·8,942 affected·Sep 14, 2020
High RiskFDA
Percussionaire Corporation
Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Respiratory Devices·212 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist ...
Cardiac Devices·32 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consi...
Cardiac Devices·16 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consi...
Medical Devices·80 affected·Sep 14, 2020
High RiskFDA
Medline Industries Inc
Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist o...
Medical Devices·20 affected·Sep 14, 2020
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Medical Devices·9,907 affected·Sep 12, 2020
High RiskFDA
Genesis Partnership Company Sa
Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis Partnership Compan...
Topical Drugs·5,040 affected·Sep 11, 2020
High RiskFDA
Genesis Partnership Company Sa
Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distribution, 6100 Hollywoo...
Topical Drugs·33,480 affected·Sep 11, 2020
High RiskFDA
Genesis Partnership Company Sa
Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Partnership Company...
Topical Drugs·15,000 affected·Sep 11, 2020
High RiskFDA
Genesis Partnership Company Sa
Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For:...
Topical Drugs·8,600 affected·Sep 11, 2020
High RiskFDA
Genesis Partnership Company Sa
Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, For: Kil...
Topical Drugs·5,320 affected·Sep 11, 2020
High RiskFDA
Bien-air Surgery Sa
Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical e...
Medical Devices·1,120 affected·Sep 11, 2020
High RiskFDA
Skytron, Div. The Kmw Group, Inc
VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System Mo...
Medical Devices·11 affected·Sep 11, 2020
High RiskFDA
Bien-air Surgery Sa
Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energ...
Medical Devices·1,120 affected·Sep 11, 2020
High RiskFDA
Rti Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-...
Medical Devices·143 affected·Sep 11, 2020
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Synapse PACS Software Version 5.6.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or ex...
Medical Devices·1 affected·Sep 11, 2020
High RiskFDA
Bien-air Surgery Sa
Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive h...
Medical Devices·1,120 affected·Sep 11, 2020
High RiskFDA
Tandem Diabetes Care Inc
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology
Diabetes Devices·5,206 affected·Sep 10, 2020
High RiskFDA
Gilster-mary Lee Corp.
Microwave popcorn packaged in the following ways: 1) Full Circle Organic Microwave Popcorn Salted, 3-2.9 oz (82 g) bags, Net Wt. 8.7 o...
Snacks & Candy·1,890 affected·Sep 9, 2020
High RiskFDA
Shatto Milk Co
Shatto Milk Company, Brownie, Chocolate Brownie and Vanilla Ice Cream Sammich, Net Wt. 5 oz, Shatto Milk Company, Osborn, MO
Dairy·308 affected·Sep 9, 2020
High RiskFDA
Gilster-mary Lee Corp.
Light microwave popcorn packaged in the following ways: 1) Full Circle Organic Microwave Popcorn Light Butter, 3-2.9 oz (82 g) bags, N...
Dairy·972 affected·Sep 9, 2020
High RiskFDA
Gilster-mary Lee Corp.
Lightly salted microwave popcorn packaged in the following ways: 1) Cadia Organic Lightly Salted Popcorn, Net Wt. 9.9 oz (281 g) 3-3.3...
Dairy·320 affected·Sep 9, 2020
High RiskFDA
Shatto Milk Co
Shatto Milk Company, Choc + Chip, Chocolate Chip Cookie and Vanilla Ice Cream Sammich, Net Wt. 4.5 oz, Shatto Milk Company, Osborn, MO
Dairy·333 affected·Sep 9, 2020
High RiskFDA
Lidl Us Trading
Lidl Organic Butter Microwave Popcorn, 3 x 3.3oz, 10 boxes per case and 3 popcorn bags per box .
Dairy·3,782 affected·Sep 9, 2020
High RiskFDA
Gilster-mary Lee Corp.
Cadia Organic Unsalted Microwave Popcorn, Net Wt. 8.4 oz (238 g) 3-2.8 oz (79 g) bags, KeHDistributors LLC, Naperville, IL, UPC 15369-01289
Snacks & Candy·34 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product Number: 7210710
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic X-ray system, primarily for urological application...
Medical Devices·6 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202616
Medical Devices·263,874 affected·Sep 9, 2020
High RiskFDA
Smith & Nephew, Inc.
OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
Medical Devices·263,874 affected·Sep 9, 2020