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
Konica Minolta Medical Imaging Usa, Inc.
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A8AR, UDI: 04560141941588
Medical Devices·17 affected·Dec 4, 2017
High RiskFDA
Beckman Coulter Inc.
iChem VELOCITY Urine Chemistry Strips, REF 800-7212 Product Usage: The iChem VELOCITY automated urine chemistry system is an in vitro...
Diabetes Devices·14,340 affected·Dec 4, 2017
High RiskFDA
Cellavision Ab
CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Produc...
Medical Devices·224 affected·Dec 4, 2017
High RiskFDA
Accord Media, Llc
Ultra Renew Plus
Medical Devices·1,040 affected·Dec 4, 2017
High RiskFDA
Konica Minolta Medical Imaging Usa, Inc.
Sonimage HS1 Ultrasound Kit AC adapter, Product Number: 1. A9RP, UDI: 04560141945463; 2. AAEU, UDI: 04560141946385; 3. A9RR, UDI: 0456014...
Medical Devices·30 affected·Dec 4, 2017
CriticalFDA
Physio-control, Inc.
LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, ...
Cardiac Devices·3,831 affected·Dec 4, 2017
High RiskFDA
Life Technologies Corporation
Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The ...
Diagnostic Devices·9 affected·Dec 4, 2017
High RiskFDA
Elekta, Inc.
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Inf...
Medical Devices·2,998 affected·Dec 1, 2017
High RiskFDA
Mako Surgical Corporation
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Medical Devices·126 affected·Dec 1, 2017
High RiskFDA
Stryker Sustainability Solutions
3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for use in preventin...
Medical Devices·280 affected·Dec 1, 2017
High RiskFDA
Ohmeda Medical
Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purcha...
Medical Devices·1,179 affected·Dec 1, 2017
High RiskFDA
Raley's
Raley's All Butter Meyer Lemon Cookie; Case of Raw Dough (168 cookies) 28.87 lbs - UPC 10659728; 1 cookie (85 g); 6 count package UPC ...
Dairy·57 affected·Nov 30, 2017
RecallFDA
Byl Solutions Inc.
Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Technology CO., LTD, BYL Solutions, Inc. dba Nutra Labs, Inc.,...
Oral Drugs·329 affected·Nov 30, 2017
High RiskFDA
Intrathecal Compounding Specialist, Llc
All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and No...
Drugs·0 affected·Nov 30, 2017
High RiskFDA
Intrathecal Compounding Specialist, Llc
All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 ...
Drugs·0 affected·Nov 30, 2017
High RiskFDA
Intrathecal Compounding Specialist, Llc
All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 an...
Drugs·0 affected·Nov 30, 2017
High RiskFDA
Intrathecal Compounding Specialist, Llc
All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between October 16, 2017 ...
Drugs·0 affected·Nov 30, 2017
High RiskFDA
Donkey Salsa
SALSA HOT Net Wt. 15 oz (426 G)
Food·216 affected·Nov 29, 2017
High RiskFDA
Donkey Salsa
SALSA NOT HOT Net Wt. 15 oz (426G)
Food·216 affected·Nov 29, 2017
High RiskFDA
Prinston Pharmaceutical Inc
Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhe...
Oral Drugs·21,987 affected·Nov 29, 2017
CriticalFDA
Blue Fusion Natural
BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
Oral Drugs·300 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT This device is indicated for patients with severe knee ...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SI...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMOR...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (...
Medical Devices·1,023 affected·Nov 29, 2017
High RiskFDA
Smith & Nephew, Inc.
smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (1...
Medical Devices·12 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Hologic, Inc.
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
Medical Devices·165 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ LPS-FLEX GSF OPT SZ D-R¿ LPS-FLEX GSF OPT SZ E-L¿ LPS-FLE...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC L...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Smiths Medical Asd Inc.
BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the r...
Medical Devices·10 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP SIZE E/R CR PRECOAT FEM CO...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT ...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSYS 8 INCH BEADED FC 12X200MM STR STD BODY/NECK 13X200MM STR STD BODY/NECK 14X200MM STR STD BODY/NECK REV 13.5X200MM BWD LT 15X2...
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSYS 7.5 IN BEADED FC +10 CALCAR 13.5X180MM STR +10 CALCAR 15.5X180MM STR +20 CALCAR 16.5X180MM STR Prosthesis, Hip, Semi-Constr...
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP FEM D-L MINUS CR-FLX POR HATCP FEM D-R MINUS CR-FLX PO...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LCCK FEM IMPLANT SZ E-L LCCK FEM IMPLANT SZ E-R LCCK FEM IMP...
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CR-FLEX OPT FEM C-L CR-FLEX OPT FEM C-R CR-FLEX OPT FEM D-L CR-FLEX OPT FEM D-R CR-FLEX OPT FEM E-L CR-FLEX OPT FEM E-R CR-FLEX OPT...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSYS 10 INCH BEADED FC REV 13.5X250MM BWD LT and RT VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CR-FLEX GSF PCT SZ C-R MINUS¿ CR-FLEX GSF PCT SZ D-L MINUS¿ CR-FLEX GSF PCT SZ D-R MINUS¿ CR-FLEX GSF PCT SZ E-L MINUS¿ CR-FLEX GSF P...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CR-FLEX POR FEM F-L CR-FLEX POR FEM F-R MINUS CR-FLEX POR FEM G-L This device is indicated for patients with severe knee pain and di...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
PATELLO-FEMORAL JOINT SYSTEM GENDER SOLUTIONS PATELLO-FEMORAL¿ Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chond...
Medical Devices·13,227 affected·Nov 29, 2017