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
www.fda.gov →Official Site

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68,659 recalls
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 5.5mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related ti...
Medical Implants·99 affected·May 22, 2014
High RiskFDA
Philips Medical Systems, Inc.
IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
Medical Devices·42,600 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue durin...
Medical Implants·72 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related...
Medical Implants·41 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related t...
Medical Implants·39 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 6.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related ti...
Medical Implants·301 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue duri...
Medical Implants·252 affected·May 22, 2014
CriticalFDA
Kind, Llc
KIND HEALTHY GRAINS Maple Pumpkin Seed Bar, 35g, packaged in a purple, black and transparent wrapper. Sold individually or packaged in a ...
Food·16,002 affected·May 21, 2014
CriticalFDA
Kind, Llc
STRONG & KIND Thai Sweet Chili Almond Protein Bar, 45g, packaged in a purple, black and transparent wrapper. Sold individually or package...
Food·14,300 affected·May 21, 2014
CriticalFDA
Kind, Llc
STRONG & KIND Honey Mustard Almond Protein Bar, 45g, packaged in a yellow, black and transparent wrapper. Sold individually or packaged i...
Food·16,869 affected·May 21, 2014
CriticalFDA
Kind, Llc
STRONG & KIND Roasted Jalapeno Almond Protein Bar, 45g, packaged in a green, black and transparent wrapper. Sold individually or packaged...
Food·12,190 affected·May 21, 2014
CriticalFDA
Kind, Llc
STRONG & KIND Hickory Smoked Almond Protein Bar, 45g, packaged in a grey, black and transparent wrapper. Sold individually or packaged in...
Food·3,525 affected·May 21, 2014
CriticalFDA
Kind, Llc
STRONG & KIND Honey Smoked BBQ Almond Protein Bar, 45g, packaged in a red, black and transparent wrapper. Sold individually or packaged i...
Food·3,494 affected·May 21, 2014
Medium RiskFDA
Valeant Pharmaceuticals North America Llc
Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceut...
Oral Drugs·205,853 affected·May 21, 2014
Medium RiskFDA
Valeant Pharmaceuticals North America Llc
Vasotec (enalapril maleate) tablets, RX only, Manufactured by Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada ...
Oral Drugs·205,853 affected·May 21, 2014
High RiskFDA
Brainlab Ag
Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimall...
Medical Devices·17 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic ...
Surgical Devices·2,014 affected·May 21, 2014
RecallFDA
Becton Dickinson & Co.
BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identificatio...
Diabetes Devices·18 affected·May 21, 2014
High RiskFDA
Teleflex Medical
RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708. A tubular devi...
Medical Devices·1,000 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instr...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic I...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 031497730...
Diagnostic Devices·462 affected·May 21, 2014
High RiskFDA
Seaspine Inc
Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws...
Medical Implants·7 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic ...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic In...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Inst...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) ...
Diagnostic Devices·149 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. ...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Intuitive Surgical, Inc.
Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical En...
Surgical Devices·2,014 affected·May 21, 2014
High RiskFDA
Royal Rye Llc
KrustaVita¿ Bread of Life brand Sourdough Dark Rye Bread; Net Weight 20 oz (1.25 lb); packed in a clear plastic bag. UPC: 8 5243000200 6.
Bakery & Grains·128 affected·May 20, 2014
CriticalFDA
Sherman Produce Co
Bulk shelled walnuts packaged in 25 lb. cardboard boxes labeled with GSF LLC, Combo Halves and Pieces, Visalia, CA. 4024 CHP, also label...
Food·2 affected·May 20, 2014
CriticalFDA
Sherman Produce Co
Schnucks walnuts packaged in 10 oz. plastic trays. IPC 003383900325 Packed by Sherman Produce Company, St. Louis, MO.
Produce·359 affected·May 20, 2014
High RiskFDA
Cambrex Charles City Inc
Mesalamine, U.S.P. [CAS 89-57-6] Cambrex Charles City, Inc. Charles City, IA packaged in double lined PE liners inside Poly-lined cardboa...
Drugs·2,351 affected·May 20, 2014
High RiskFDA
West-ward Pharmaceutical Corp.
Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Man...
Oral Drugs·17,347 affected·May 20, 2014
CriticalFDA
Customed, Inc
Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL PUSH BOTTOM (4) TOWELS ABSORBENT 15" X 20" L/...
Surgical Devices·2 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LI...
Surgical Devices·3 affected·May 20, 2014
CriticalFDA
Customed, Inc
LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X 96" LIF (5) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND C...
Surgical Devices·19 affected·May 20, 2014
CriticalFDA
Customed, Inc
ARTHROSCOPY PACK I (1) CUSTOMED CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) MAYO STAN...
Surgical Devices·4 affected·May 20, 2014
CriticalFDA
Customed, Inc
PEDIATRIC LAP PACK - ( I) SHEET MINOR LAP 102" X 121" X 78" ( I) MAYO STAND COVER REINFORCED LIF ( I) TABLE COVER REINFORCED 50" X 90...
Surgical Devices·32 affected·May 20, 2014
CriticalFDA
Customed, Inc
PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP MEDICINE 2oz (1) DRAPE OPHTHAL. WITH POUCH LIF (1 0) SPO...
Surgical Devices·7 affected·May 20, 2014
CriticalFDA
Customed, Inc
FOLEY CATHETER KIT 1116FR. - CUSTOM ED- (1) WRAPPER 24" X 24" (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYNIL P/F ...
Surgical Devices·27 affected·May 20, 2014
CriticalFDA
Customed, Inc
ACDFPACK SURGICAL CENTER, CODE 900-2917. CONTENTS: (1) SOLUTION SURGICAL DURAPREP 6ML LIF (4) Prs. GLOVE SURG. DERMA PRENE # 8 PF...
Surgical Devices·6 affected·May 20, 2014
CriticalFDA
Customed, Inc
UMBILICAL VESSEL CATHETER KIT - CUSTOMED- (1) PAPER TAPE MEASURE DISP. 24" (1) FENESTRATED DRAPE 18" x 26" LIF (1) NEEDLE HOLDER BAU...
Surgical Devices·7 affected·May 20, 2014
CriticalFDA
Customed, Inc
Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF ...
Surgical Devices·4 affected·May 20, 2014
CriticalFDA
Customed, Inc
Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 LIF (1) UTILITY BOWL QUART 32oz LIF (1) MAYO STAND COVER ...
Surgical Devices·1 affected·May 20, 2014
CriticalFDA
Customed, Inc
ANGIOGRAPHY PACK CONTENTS: (4) CLOTH HUCK TOWEL BLUE (1) TABLE COVER REINFORCED 50" x 90" LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER ...
Surgical Devices·21 affected·May 20, 2014