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
Pfizer Inc.
Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles ( NDC ...
Oral Drugs·7,901 affected·Mar 28, 2013
High RiskFDA
Pfizer Inc.
Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles ( NDC ...
Oral Drugs·10,121 affected·Mar 28, 2013
High RiskFDA
Pfizer Inc.
Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles ( NDC ...
Oral Drugs·14,464 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended...
Medical Devices·31,940 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended...
Medical Devices·19,030 affected·Mar 28, 2013
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat periarticular or intr...
Medical Devices·107 affected·Mar 28, 2013
High RiskFDA
Baxter Healthcare Corp.
A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Produ...
Surgical Devices·2 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable Collagen Membrane is an absorbable, implantable material tha...
Medical Implants·20,032 affected·Mar 28, 2013
High RiskFDA
Baxter Healthcare Corp.
A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use...
Surgical Devices·2 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urologica...
Surgical Devices·14 affected·Mar 28, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter for difficult transfer with Stylet PPS623 Sure-Pro¿ Embryo Replacement Cathet...
Surgical Devices·4,910 affected·Mar 28, 2013
High RiskFDA
Ge Healthcare, Llc
MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and obliq...
Diagnostic Devices·70 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for ...
Medical Implants·812 affected·Mar 28, 2013
High RiskFDA
Advanced Sterilization Products
EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submer...
Medical Devices·761 affected·Mar 28, 2013
High RiskFDA
Ge Healthcare, Llc
Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee...
Medical Devices·81 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGe...
Medical Implants·52 affected·Mar 28, 2013
High RiskFDA
Transonic Systems Inc
HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. ...
Cardiac Devices·195 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has be...
Medical Devices·954 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated fo...
Medical Implants·32,446 affected·Mar 28, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro¿ Embryo Replacement Catheters are us...
Surgical Devices·59,089 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for th...
Medical Implants·215 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieve...
Medical Devices·1,661 affected·Mar 28, 2013
CriticalFDA
Siemens Medical Solutions Usa, Inc.
Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ...
Cardiac Devices·120 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
Absorbable Collagen Sponge Provided As Intermediate to Another Company
Medical Devices·84,460 affected·Mar 28, 2013
High RiskFDA
Baxter Healthcare Corp.
A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for ...
Surgical Devices·2 affected·Mar 28, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro¿ Embryo Replacement Cat...
Surgical Devices·22,380 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intende...
Medical Devices·32,790 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to han...
Medical Implants·15,607 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended ...
Medical Devices·17,110 affected·Mar 28, 2013
High RiskFDA
Integra Lifesciences Corporation
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dur...
Medical Implants·21,179 affected·Mar 28, 2013
High RiskFDA
Tristar Food Wholesale Co Inc
Fructus Lycii (400g). Dried Medlar (Net Wt: 14.11 oz (400G). Ingredients: Dried Medlar. Distributed Exclusively By: Tristar Food Whol...
Food·19 affected·Mar 27, 2013
High RiskFDA
Red Eagle Enterprises
Large Cheese Crisp & Burrito Size, one dozen, net wt. 30 oz
Dairy·6,499 affected·Mar 27, 2013
High RiskFDA
Naturebox, Inc.
NatureBox brand Umami Almonds packed in branded stand-up pouches (whole tamari flavored almonds), Net wt. 4.3 oz. No UPC Codes on the pr...
Dairy·802 affected·Mar 27, 2013
High RiskFDA
New Seasons Market
Product does not have a label. The consignees are provided with an ingredient statement for all the products they purchase. The product...
Food·14 affected·Mar 27, 2013
High RiskFDA
Red Eagle Enterprises
Small Flour Gorditas, one dozen, net wt. 24 oz
Food·9,258 affected·Mar 27, 2013
RecallFDA
Legacy Pharmaceutical Packaging Llc
Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60
Oral Drugs·1,644 affected·Mar 27, 2013
High RiskFDA
Accuray Incorporated
RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosur...
Medical Devices·16 affected·Mar 27, 2013
High RiskFDA
Stryker Endoscopy
Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing th...
Medical Devices·147,921 affected·Mar 27, 2013
High RiskFDA
Stryker Endoscopy
Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflective Finish. Suction irrigator tips aid in cleaning and cl...
Medical Devices·147,921 affected·Mar 27, 2013
High RiskFDA
Stryker Endoscopy
Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the ...
Medical Devices·147,921 affected·Mar 27, 2013
High RiskFDA
Stryker Endoscopy
Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearin...
Medical Devices·147,921 affected·Mar 27, 2013
High RiskFDA
Summit Medical, Inc.
Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul,...
Medical Devices·9 affected·Mar 27, 2013
High RiskFDA
Stryker Endoscopy
Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearin...
Medical Devices·147,921 affected·Mar 27, 2013
High RiskFDA
Stryker Endoscopy
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and cl...
Medical Devices·147,921 affected·Mar 27, 2013
High RiskFDA
Stryker Endoscopy
Stryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with 30¿ Downward Bend At Proximal End. Suction irrigator tips...
Medical Devices·147,921 affected·Mar 27, 2013
High RiskFDA
Stryker Endoscopy
Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearin...
Medical Devices·147,921 affected·Mar 27, 2013
High RiskFDA
Stryker Endoscopy
Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and cl...
Medical Devices·147,921 affected·Mar 27, 2013
High RiskFDA
Stryker Endoscopy
Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing th...
Medical Devices·147,921 affected·Mar 27, 2013