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
Stryker Neurovascular
Guider Softip XF; GUIDER/MP XF/6FR/90CM, Model number: H965100460. Cardiology: Boston Scientific Guider Softip XF Guide Catheters a...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER MPXF 5F 100CM, Model number: M003101630. Cardiology: Boston Scientific Guider Softip XF Guide Catheters ar...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Intuitive Surgical, Inc.
da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical End...
Surgical Devices·677 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/ST XF/6FR/100 cm, Model number:M003101500 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introd...
Cardiac Devices·1,729 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of t...
Cardiac Devices·21 affected·Oct 5, 2016
CriticalFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or olde...
Medical Devices·11,860 affected·Oct 5, 2016
CriticalFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No...
Medical Devices·3,337 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the...
Cardiac Devices·74 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 Is designed to facilitate the introduction of catheters to any of the...
Cardiac Devices·70 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Catalog # 990079-055-000 Is designed to facilitate the introdu...
Cardiac Devices·59 affected·Oct 5, 2016
High RiskFDA
Alphatec Spine, Inc.
Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for pos...
Surgical Devices·16,972 affected·Oct 5, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 (500 test)
Diagnostic Devices·37,437 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000 Is designed to facilitate the introduct...
Cardiac Devices·45 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 Is designed to facilitate the introduction of catheters to any of the h...
Cardiac Devices·30 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the h...
Cardiac Devices·156 affected·Oct 5, 2016
High RiskFDA
C.r. Bard, Inc.
Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile Product Usage: The catheter is an all silicone,...
Surgical Devices·10,290 affected·Oct 5, 2016
CriticalFDA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 ...
Medical Devices·10,516 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is designed to facilitate the introduction of catheters to any of ...
Cardiac Devices·26 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed to facilitate the introdu...
Cardiac Devices·186 affected·Oct 5, 2016
High RiskFDA
Maquet Medical Systems Usa
Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interfa...
Surgical Devices·9 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 . Cardiology: Boston Scientific Guider Softip XF Guide Cath...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of...
Cardiac Devices·34 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the h...
Cardiac Devices·991 affected·Oct 5, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc
Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test)
Diagnostic Devices·69,781 affected·Oct 5, 2016
High RiskFDA
Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is designed to facilitate the introduction of catheters to any of the...
Cardiac Devices·124 affected·Oct 5, 2016
High RiskFDA
Stryker Neurovascular
Guider Softip XF; GUIDER/MP XF/7FR/90CM, Model number: H965100470. Cardiology: Boston Scientific Guider Softip XF Guide Catheters a...
Surgical Devices·1,478 affected·Oct 5, 2016
High RiskFDA
Del Monte Research Center - Walnut Creek
DM Light Slices Yellow Cling Peaches -15 oz (425g) 300 x 407
Food·5,728 affected·Oct 4, 2016
CriticalFDA
Inpeco S.a.
FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, s...
Medical Devices·188 affected·Oct 4, 2016
High RiskFDA
Medtronic
Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to...
Medical Devices·230 affected·Oct 4, 2016
High RiskFDA
Roche Diagnostics Operations, Inc.
COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
Medical Devices·4,976 affected·Oct 4, 2016
High RiskFDA
Medtronic
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedure...
Medical Devices·1,293,169 affected·Oct 4, 2016
High RiskFDA
Mel-o Cream Donuts International, Inc.
Star Shaped Shells; Best If Used By 02/26/2017; Batch 162734736; NET WT 11.46 Pounds; Approximate Unit Count [Per Case]: 9 Dozen [108 un...
Food·9 affected·Oct 3, 2016
High RiskFDA
Mel-o Cream Donuts International, Inc.
Fried Danish; Best If Used By 02/25/2017; Batch 162724711; NET WT 11.25 Pounds; Approximate Unit Count: 89 pcs.
Food·23 affected·Oct 3, 2016
High RiskFDA
Mel-o Cream Donuts International, Inc.
Jumbo Apple Fritter; Approximate Unit Count: 6 Dozen; Mel-O-Cream Donuts Intl. Inc. Springfield, IL 62711
Dairy·196 affected·Oct 3, 2016
High RiskFDA
Mel-o Cream Donuts International, Inc.
Hy Vee Long Shells (Red Raspberry Filled); Best If Used By 02/26/2017; Batch 162734720; NET WT 26.48 Pounds; Approximate Unit Count: 84 u...
Produce·93 affected·Oct 3, 2016
High RiskFDA
Mel-o Cream Donuts International, Inc.
Arrowhead/Christmas Tree Shells; Best If Used By 02/26/2017; Batch 162734737; NET WT 12 Pounds; Approximate Unit Count [Per Case]: 8 Doze...
Food·20 affected·Oct 3, 2016
High RiskFDA
Mel-o Cream Donuts International, Inc.
Hy Vee Shells (Bavarian Filled); Best If Used By 02/25/2017; Batch 162724703; NET WT 26.48 Pounds; Approximate Unit Count: 84 units
Food·24 affected·Oct 3, 2016
High RiskFDA
Mel-o Cream Donuts International, Inc.
Jumbo Pershing (Cinnamon) Rolls; NET WT 11.25 and 16.1 Pounds; Approximate Unit Count [Per Case]: 6-8 Dozen; Brands: Mel-O-Cream and Hy-Vee
Dairy·226 affected·Oct 3, 2016
High RiskFDA
Mel-o Cream Donuts International, Inc.
Hy Vee Long Johns (Red Raspberry Filled); Best If Used By 02/25/2017; Batch 162724690; NET WT 14.63 Pounds; Approximate Unit Count: 72 units
Produce·3 affected·Oct 3, 2016
High RiskFDA
Taiwan Seafood & Fish Corporation
Yellowfin Tuna Ground Meat, 22 lbs./case, 5500 lbs Two boxes per case, 11 one pound packages per box, 22 one pound packages per case
Meat & Poultry·250 affected·Oct 3, 2016
High RiskFDA
West-ward Pharmaceuticals Corp.
Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01
Oral Drugs·0 affected·Oct 3, 2016
High RiskFDA
West-ward Pharmaceutical
PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-4741...
Oral Drugs·15,109 affected·Oct 3, 2016
High RiskFDA
Synthes (usa) Products Llc
Extraction Hook - Sterile for TI Cannulated Nails
Medical Devices·114 affected·Oct 3, 2016
High RiskFDA
Synthes (usa) Products Llc
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
Medical Devices·319 affected·Oct 3, 2016
High RiskFDA
Medimaps Group
TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analy...
Medical Devices·15 affected·Oct 3, 2016
High RiskFDA
Synthes (usa) Products Llc
3.0 mm Reaming Rod/950 mm, Sterile
Medical Devices·887 affected·Oct 3, 2016
CriticalFDA
Medtronic Neuromodulation
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Visi...
Medical Implants·22,298 affected·Oct 3, 2016