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
Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M*...
Medical Devices·1,800 affected·Jun 16, 2010
High RiskFDA
Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 (16.51cm) Length***Reorder: ES0014M**...
Medical Devices·3,600 affected·Jun 16, 2010
High RiskFDA
Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ...
Medical Devices·1,440 affected·Jun 16, 2010
High RiskFDA
Unimed Surgical Products, Inc.
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016A...
Medical Devices·1,440 affected·Jun 16, 2010
High RiskFDA
Smiths Medical Asd, Inc.
Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of flu...
Medical Devices·6 affected·May 14, 2010
High RiskFDA
Cayenne Medical Inc.
AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; ...
Medical Implants·1,444 affected·Apr 28, 2010
High RiskFDA
Physio-control, Inc.
The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings with...
Cardiac Devices·1,399 affected·Mar 11, 2010
High RiskFDA
K C Pharmaceuticals Inc
Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%) ophthalmic solution, 1/2...
Ophthalmic Drugs·31,704 affected·Mar 1, 2010
High RiskFDA
Mallinckrodt Inc
The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that pro...
Medical Devices·75 affected·Feb 1, 2010
High RiskFDA
Orthohelix Surgical Designs Inc
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxT...
Medical Devices·47 affected·Jan 29, 2010
High RiskFDA
Lockheed Martin Gyrocam Systems, Inc.
Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from...
Medical Devices·33 affected·Jan 21, 2010
High RiskFDA
Medacta Usa Inc
Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26...
Medical Devices·293 affected·Jan 15, 2010
High RiskFDA
Sendx Medical Inc
ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyze...
Diabetes Devices·767 affected·Jan 6, 2010
High RiskFDA
Spiegelberg Gmbh & Co. Kg
Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: ...
Medical Devices·22 affected·Dec 29, 2009
High RiskFDA
Gmp Laboratories Of America Inc
Dietary supplement. Product is labeled as :" Rescue Me***911 Damage Control***brantley living herbal formulas***HERBAL SUPPLEMENT 15 INDI...
Baby Food & Formula·1,027 affected·Dec 8, 2009
High RiskFDA
Naimco Inc Dba Richmar Inc
Foam Electrodes with Carbon construction: P/N 201-1261, Cat Nos.: 201-126, 203-678, and 400-856, 1.5" x 3.5" Electrode...
Medical Devices·129,400 affected·Nov 30, 2009
High RiskFDA
Naimco Inc Dba Richmar Inc
Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-898, 2" x 2" Electrode, Foam, AG, All Seria...
Medical Devices·56,980 affected·Nov 30, 2009
High RiskFDA
Naimco Inc Dba Richmar Inc
Cloth electrodes with Silver-Carbon construction: P/N 202-9231, Cat No. 400-899, 2" x 2" Electrode, Cloth, AG, All Ser...
Medical Devices·25,860 affected·Nov 30, 2009
High RiskFDA
Naimco Inc Dba Richmar Inc
Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-...
Medical Devices·209,860 affected·Nov 30, 2009
High RiskFDA
Carefusion Corporation
Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provid...
Medical Devices·2,637 affected·Nov 20, 2009
High RiskFDA
Biosense Webster, Inc.
CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system ...
Cardiac Devices·71 affected·Nov 17, 2009
High RiskFDA
Olympus America Inc.
Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage: Designed for use in a medical facility under the supervision...
Respiratory Devices·608 affected·Nov 10, 2009
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexib...
Medical Devices·33 affected·Oct 2, 2009
High RiskFDA
Terumo Cardiovascular Systems Corporation
Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the e...
Medical Devices·8 affected·Aug 12, 2009
High RiskFDA
Baxter Healthcare Corp.
Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of ...
Medical Devices·2 affected·Jul 31, 2009
High RiskFDA
Baxter Healthcare Corp.
Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of ...
Medical Devices·2 affected·Jul 31, 2009
RecallFDA
Medtest Holdings, Inc.
Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to us...
Diagnostic Devices·323 affected·Jul 21, 2009
CriticalFDA
Smith Dairy Products Co
Smith's Old Fashioned Lemon Flavor Iced Tea, pasteurized, packed in 1 gallon (3.78L) containers. The label also reads: 'Smith's The Dai...
Dairy·12,405 affected·Jun 16, 2009
High RiskFDA
Orthosoft, Inc. Dba Zimmer Cas
NDI P7 Position Sensor, Stereotaxic Instrument
Medical Devices·34 affected·Jun 9, 2009
High RiskFDA
Karl Storz Endoscopy America Inc
Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Medical Devices·9,432 affected·Jun 1, 2009
High RiskFDA
Karl Storz Endoscopy America Inc
Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Medical Devices·9,432 affected·Jun 1, 2009
High RiskFDA
Karl Storz Endoscopy America Inc
Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Medical Devices·9,432 affected·Jun 1, 2009
High RiskFDA
Karl Storz Endoscopy America Inc
Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Medical Devices·9,432 affected·Jun 1, 2009
High RiskFDA
Karl Storz Endoscopy America Inc
Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Medical Devices·9,432 affected·Jun 1, 2009
High RiskFDA
Karl Storz Endoscopy America Inc
Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Medical Devices·9,432 affected·Jun 1, 2009
High RiskFDA
Karl Storz Endoscopy America Inc
Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Medical Devices·9,432 affected·Jun 1, 2009
High RiskFDA
Karl Storz Endoscopy America Inc
Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
Medical Devices·9,432 affected·Jun 1, 2009
High RiskFDA
Alere San Diego, Inc.
Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be ...
Diagnostic Devices·45,638 affected·May 28, 2009
RecallFDA
Spinal Elements, Inc
Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of t...
Medical Devices·68 affected·Apr 17, 2009
RecallFDA
Spinal Elements, Inc
Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. Intended to provide immobilization and stabilization of t...
Medical Devices·68 affected·Apr 17, 2009
RecallFDA
Spinal Elements, Inc
Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and stabilization of th...
Medical Devices·68 affected·Apr 17, 2009
RecallFDA
Spinal Elements, Inc
Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. Intended to provide immobilization and stabilization of t...
Medical Devices·68 affected·Apr 17, 2009
RecallFDA
Spinal Elements, Inc
Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to provide immobilization and stabilization of th...
Medical Devices·68 affected·Apr 17, 2009
RecallFDA
Spinal Elements, Inc
Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to provide immobilization and stabilization of th...
Medical Devices·68 affected·Apr 17, 2009
RecallFDA
Spinal Elements, Inc
Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and stabilization of t...
Medical Devices·68 affected·Apr 17, 2009
RecallFDA
Spinal Elements, Inc
Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization and stabilization of th...
Medical Devices·68 affected·Apr 17, 2009
RecallFDA
Spinal Elements, Inc
Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. Intended to provide immobilization and stabilization of th...
Medical Devices·68 affected·Apr 17, 2009
RecallFDA
Spinal Elements, Inc
Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to provide immobilization and stabilization of t...
Medical Devices·68 affected·Apr 17, 2009