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
Xeridiem Mediem Medical Devices Inc
EndoVive 3s Low Profile Balloon Kits Part Number: M00549360 (XMD P/N 70-0050-622) The EndoVive 3s Low Profile Balloon is intended to ...
Medical Devices·35 affected·Dec 23, 2015
High RiskFDA
Fujifilm Medical Systems U.s.a., Inc.
Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
Medical Devices·1,473 affected·Dec 23, 2015
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images.
Diagnostic Devices·895 affected·Dec 23, 2015
High RiskFDA
Pro-dex Inc
Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdr...
Surgical Devices·1,995 affected·Dec 23, 2015
CriticalFDA
Uoriki Fresh Inc
Uoriki Octopus Salad Net Weight 2.5 lbs Two 2.5lbs pack per case packaged in Black trays covered w/cryovac 10k film no barcode....
Produce·10 affected·Dec 22, 2015
High RiskFDA
Grato Holdings, Inc.
Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle, NDC 44911-0136-1, Dist. by Energique, Inc....
Topical Drugs·118 affected·Dec 22, 2015
High RiskFDA
Grato Holdings, Inc.
Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0132-1, Dist. by Ene...
Topical Drugs·201 affected·Dec 22, 2015
High RiskFDA
Grato Holdings, Inc.
Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0137-1, Dist. by Ener...
Topical Drugs·371 affected·Dec 22, 2015
High RiskFDA
Grato Holdings, Inc.
Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0134-1, Dist. by ...
Topical Drugs·90 affected·Dec 22, 2015
High RiskFDA
Grato Holdings, Inc.
Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml) bottles, NDC 44911-0135-1, Dist. by Energique, Inc., Woodb...
Topical Drugs·118 affected·Dec 22, 2015
High RiskFDA
Grato Holdings, Inc.
Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0133-1, Dist. by Energiqu...
Topical Drugs·224 affected·Dec 22, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, di...
Medical Devices·68 affected·Dec 22, 2015
High RiskFDA
Applied Medical Resources Corp
STD KIT GK260, Standard Set 360 Z Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular ...
Surgical Devices·0 affected·Dec 22, 2015
High RiskFDA
Ultradent Products, Inc.
InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preve...
Medical Devices·157 affected·Dec 22, 2015
High RiskFDA
Hospira Inc.
The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended...
Surgical Devices·6,634 affected·Dec 22, 2015
High RiskFDA
Applied Medical Resources Corp
STD KIT GK213, AME Standard Kit 15 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular...
Surgical Devices·0 affected·Dec 22, 2015
CriticalFDA
Draeger Medical, Inc.
Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventil...
Respiratory Devices·0 affected·Dec 22, 2015
CriticalFDA
Draeger Medical, Inc.
Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704...
Respiratory Devices·402 affected·Dec 22, 2015
High RiskFDA
Applied Medical Resources Corp
STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular str...
Surgical Devices·0 affected·Dec 22, 2015
High RiskFDA
Zingerman's Candy Manufactory
Chocolate Marshmallows, 8 oz., packaged in plastic bags, UPC 8 44397 00077 5
Snacks & Candy·134 affected·Dec 21, 2015
High RiskFDA
Zingerman's Candy Manufactory
Zzang! Original Candy Bar, 2.5 oz., packaged in preprinted cardboard boxes, UPC 8 44397 00014 0
Snacks & Candy·14,433 affected·Dec 21, 2015
High RiskFDA
This Bar Saves Lives
This Kid Saves Lives Chocolate Chip UPC #10858497004097 UPC# 858497004090
Snacks & Candy·20,829 affected·Dec 21, 2015
High RiskFDA
Zingerman's Candy Manufactory
Zzang! Wowza Candy Bar,3 oz., packaged in reprinted cardboard boxes, UPC 8 44397 00072 0
Snacks & Candy·1,499 affected·Dec 21, 2015
High RiskFDA
Zingerman's Candy Manufactory
Zzang! Cashew Cow Candy Bar,2 oz., packaged in reprinted cardboard boxes, UPC 8 44397 00015 7
Snacks & Candy·3,242 affected·Dec 21, 2015
High RiskFDA
Zingerman's Candy Manufactory
Zzang! Holiday 4 pack Candy Bars, 10.5 oz., packaged in preprinted cardboard boxes
Snacks & Candy·14,433 affected·Dec 21, 2015
High RiskFDA
Teva North America
Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industri...
Oral Drugs·1,895 affected·Dec 21, 2015
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx...
Topical Drugs·2,088 affected·Dec 21, 2015
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 30-count patches per box, Rx...
Topical Drugs·7,850 affected·Dec 21, 2015
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx...
Topical Drugs·12,285 affected·Dec 21, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740; IVD. Product Usage: For use in ...
Diagnostic Devices·1,009 affected·Dec 21, 2015
High RiskFDA
Baxter Corporation Englewood
Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
Medical Devices·4,695 affected·Dec 21, 2015
High RiskFDA
Northeast Laboratory Services, Inc.
NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.: T8000; For the selective enrichment and screening of Beta-Hemo...
Medical Devices·11,720 affected·Dec 21, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry Syste...
Diagnostic Devices·994 affected·Dec 21, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054; IVD. Product Usage: For in vitro...
Diagnostic Devices·885 affected·Dec 21, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, ...
Diagnostic Devices·802 affected·Dec 21, 2015
High RiskFDA
Acist Medical Systems
ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only...
Surgical Devices·48,614 affected·Dec 21, 2015
High RiskFDA
Ortho-clinical Diagnostics
VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343; IVD. Product Usage: For in vitr...
Diagnostic Devices·163 affected·Dec 21, 2015
High RiskFDA
Northeast Laboratory Services, Inc.
NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemo...
Medical Devices·9,300 affected·Dec 21, 2015
High RiskFDA
Conmed Corporation
Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number H...
Surgical Devices·991 affected·Dec 21, 2015
High RiskFDA
Signature Breads, Inc.
Signature Breads Frozen Parbaked Baguette 22202, 25 UNITS - 8.75 OZ, NET WT. 13.67 LB (6.2 kg), in a cardboard box
Bakery & Grains·1,893 affected·Dec 20, 2015
High RiskFDA
Signature Breads, Inc.
Signature Breads Frozen Parbaked French Sub Grande 22089; 36 UNITS - 5.9 OZ, NET WT. 13.27 LB (6.02 kg), in a cardboard box
Bakery & Grains·1,893 affected·Dec 20, 2015
High RiskFDA
Signature Breads, Inc.
Signature Breads Frozen Parbaked French Petit Pain 22203, 144 UNITS - 1.75 OZ, NET WT. 15.75 LB (7.14 kg), in a cardboard box
Bakery & Grains·1,893 affected·Dec 20, 2015
High RiskFDA
Signature Breads, Inc.
Piantedosi French Dinner rolls C-301, Signature Breads French Dinner Rolls 22200, 240 UNITS - 1.25 OZ, NET WT. 18.75 LB (8.5 kg), in a ca...
Bakery & Grains·1,893 affected·Dec 20, 2015
High RiskFDA
Signature Breads, Inc.
Signature Breads Frozen Parbaked Assorted Dinner Rolls 22213; 240 UNITS - NET WT. 22.5 LB (10.2 kg), packed in a cardboard box
Bakery & Grains·1,893 affected·Dec 20, 2015
High RiskFDA
Signature Breads, Inc.
Signature Breads Frozen Parbaked French Mini Baguette 22205; 48 UNITS - 5 OZ, NET WT. 15 LB (6.8 kg), in a cardboard box
Bakery & Grains·1,893 affected·Dec 20, 2015
High RiskFDA
Signature Breads, Inc.
Signature Breads Frozen Parbaked French Dinner Roll 22245; 120 units - 1.25 OZ NET WT. 9.37 LB (4.25 KG), in a cardboard box
Bakery & Grains·1,893 affected·Dec 20, 2015
High RiskFDA
Signature Breads, Inc.
Signature Breads Frozen Parbaked French Sub Roll 22201, 72 UNITS - 3.25 OZ, NET WT. 14.62 LB (6.63 kg), in a cardboard box
Bakery & Grains·1,893 affected·Dec 20, 2015
High RiskFDA
Signature Breads, Inc.
Signature Breads Frozen Parbaked Assorted Petit Pain 22032; 144 UNITS - 1.75 OZ, NET WT. 15.75 LB (7.14 kg), in a cardboard box
Bakery & Grains·1,893 affected·Dec 20, 2015