Source

FDA Recalls

The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.

68,659Total Recalls
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68,659 recalls
High RiskFDA
Elekta Instrument Ab
Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based system designed for Leksell Gamma Knife treatment planning.
Medical Devices·52 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Release 3 (Stitching Patient Support) 712025
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Genicon, Inc.
Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use o...
Medical Devices·1,550 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Upgrades (Stitching Patient Support) 712083
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4.1 Chest / Emergency (Stitching Patient Support) 712029
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Biomerieux, Inc.
BACT/ALERT VIRTUO system, A Unit China, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is ...
Medical Devices·8 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082
Diagnostic Devices·2 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
EasyDiagnost Eleva DRF, Release 5 (Stitching Patient Support) 706050
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost 4.1 (Stitching Patient Support) 712225
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081
Diagnostic Devices·0 affected·Jun 27, 2018
High RiskFDA
Philips Medical Systems Gmbh, Dmc
CombiDiagnost R90 (Stitching Patient Support) 709030
Diagnostic Devices·0 affected·Jun 27, 2018
RecallFDA
Major Pharmaceuticals
Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, M....
Oral Drugs·5,933 affected·Jun 26, 2018
CriticalFDA
World Organix, Llc
Blissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count packaged White Foil Pouche, Dist. by World Organix LLC, Las Veg...
Oral Drugs·789 affected·Jun 26, 2018
CriticalFDA
World Organix, Llc
Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, 12mL bottle. Distributed by World Organix LLC Las Vegas Nevada. UPC#7 1...
Drugs·681 affected·Jun 26, 2018
CriticalFDA
World Organix, Llc
Blissful Remedies, 4 Hour Chill, Slow Motion Blend, Herbal Shot. 1.93 Fluid Oz (57ml) UPC#6 02401 88900 3.
Drugs·164 affected·Jun 26, 2018
CriticalFDA
World Organix, Llc
Blissful Remedies Kratom+CBD CBD infused Maeng Da, capsules 50-count packaged in While Foil Pouch. Dist. by World Organix LLC, Las Vegas...
Oral Drugs·553 affected·Jun 26, 2018
CriticalFDA
World Organix, Llc
Blissful Remedies Gold Series Ultra Enhanced Indo, 50 capsule, packaged in While Foil Pouch, Dist. by World Organix LLC, Las Vegas Nevada...
Oral Drugs·545 affected·Jun 26, 2018
RecallFDA
Major Pharmaceuticals
Enalapril Maleate Tablets, USP, 2.5 mg, 100 Tablets (10 x 10) Unit Dose per carton, Rx only, Manufactured by: Wockhardt Limited, H-14/2, ...
Oral Drugs·3,397 affected·Jun 26, 2018
High RiskFDA
Terumo Cardiovascular Systems Corporation
CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monit...
Respiratory Devices·128 affected·Jun 26, 2018
High RiskFDA
Terumo Cardiovascular Systems Corporation
Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHC...
Respiratory Devices·128 affected·Jun 26, 2018
High RiskFDA
La Vita Compounding Pharmacy, Llc
Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VITA Compounding Phar...
Injectable Drugs·17,610 affected·Jun 25, 2018
High RiskFDA
La Vita Compounding Pharmacy, Llc
Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx only, la VITA Compou...
Injectable Drugs·19,040 affected·Jun 25, 2018
RecallFDA
American Health Packaging
Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 cartons in a shipper, Rx, Packaged and Distributed by: America...
Oral Drugs·1,285 affected·Jun 25, 2018
High RiskFDA
La Vita Compounding Pharmacy, Llc
Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only, la VITA Compounding Pharmacy, 858.453...
Injectable Drugs·191 affected·Jun 25, 2018
High RiskFDA
Leica Microsystems, Inc.
Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
Medical Devices·123 affected·Jun 25, 2018
High RiskFDA
Bard Peripheral Vascular Inc
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Inter...
Medical Implants·95 affected·Jun 25, 2018
High RiskFDA
Carl Zeiss Meditec Ag
Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
Medical Devices·1 affected·Jun 25, 2018
High RiskFDA
Talking Rain Beverage Co Inc
Sparkling ICE Cherry Limeade Naturally Flavored Sparking Water, packaged in a PET bottles with a plastic cap, Net Wt. 17 ounces (502.8 ml...
Beverages·684,977 affected·Jun 22, 2018
RecallFDA
Prinova Us Llc
Prinova brand Product - Reginator NV (41825) 25 Kgs Fiber carton double layer polyethylene bag as liner
Food·3,000 affected·Jun 22, 2018
RecallFDA
Prinova Us Llc
Prinova brand Product - MRI Amintoten Strawberry Powder 25 Kgs Fiber carton double layer polyethylene bag as liner
Produce·3,350 affected·Jun 22, 2018
High RiskFDA
Brew Dr Kombucha, Llc
Brew Dr. Kombucha Clear Mind, item Code: FCG0002, 6 glass bottles per case, net volume: 32 FL OZ (946 ML). UPC: 51107 00369. The bottl...
Beverages·3,150 affected·Jun 22, 2018
RecallFDA
Prinova Us Llc
Amino Life brand Product - BCAA 2:1:1 Instant Sunflower 25 Kgs Fiber carton double layer polyethylene bag as liner
Food·1,225 affected·Jun 22, 2018
RecallFDA
Prinova Us Llc
Amino Life brand Product - L-Leucine Instant Sunflower 25 Kgs Fiber carton double layer polyethylene bag as liner
Food·1,775 affected·Jun 22, 2018
High RiskFDA
Eb5 Corporation
eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton containing a tube. Man...
Topical Drugs·4,632 affected·Jun 22, 2018
High RiskFDA
Akorn, Inc.
Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.
Injectable Drugs·89,507 affected·Jun 22, 2018
High RiskFDA
Smiths Medical Asd Inc.
Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Ele...
Medical Devices·28,578,939 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
RecallFDA
Clarity Diagnostics Llc
Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urinalysis Reagent Strips (Urine) are for the q...
Diabetes Devices·7,536 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Zimmer Biomet, Inc.
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgi...
Surgical Devices·385 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure P...
Medical Devices·22,831 affected·Jun 22, 2018
High RiskFDA
Smiths Medical Asd Inc.
Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-...
Medical Devices·28,578,939 affected·Jun 22, 2018
High RiskFDA
Stryker Leibinger Gmbh & Co. Kg
AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
Medical Devices·22,831 affected·Jun 22, 2018