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
Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC NAIL 180X13X140 STER TROC NAIL 125 DEG X 13MM STER TROC NAIL 130 DEG X 13MM STER TROC NAIL 135...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System TROCH NAIL ST 13X180 125DG STRL TROCH NAIL ST 13X180 130DG STRL TROCH NAIL ST 13X180 135DG STRL The Tr...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Merit Medical Systems, Inc.
Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialy...
Medical Implants·0 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System ATN LAG SCREW 60MM STERILE ATN LAG SCREW 65MM STERILE ATN LAG SCREW 70MM STERILE ATN LAG SCREW 75MM STER...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Integra Lifesciences Corp.
The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product ...
Medical Devices·1,619 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC END CAP STER TROC END CAP 5MM STER TROC END CAP 10MM STER TROC END CAP 15MM STER TROC END CAP...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
Boston Scientific Corporation
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Surgical Devices·5,026 affected·Dec 20, 2017
High RiskFDA
Philips Electronics North America Corporation
Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd fo...
Medical Implants·1,486 affected·Dec 20, 2017
High RiskFDA
Zimmer Biomet, Inc.
ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 130 DEG X 9MM STER TROC NAIL 135 DEG X 9MM The Trochanteri...
Medical Devices·3,454 affected·Dec 20, 2017
High RiskFDA
New Punjab Sweets Inc.
Sakkar Para, 1 lb. clear plastic clamshell containers.
Food·30 affected·Dec 19, 2017
High RiskFDA
New Punjab Sweets Inc.
Jalebi, .5-1 lb. Clear Plastic clamshell containers
Food·30 affected·Dec 19, 2017
CriticalFDA
Fresh Pak, Inc.
7oz Fruit and cheese Snacks - no brand. 1 unit per case
Dairy·160 affected·Dec 19, 2017
High RiskFDA
New Punjab Sweets Inc.
Laddu, 1 lb. clear plastic clamshell containers.
Food·15 affected·Dec 19, 2017
High RiskFDA
New Punjab Sweets Inc.
Gur Para 1 lb. clear plastic clamshell containers.
Food·30 affected·Dec 19, 2017
CriticalFDA
Fresh Pak, Inc.
9oz Mix (red/green) Slice Apples Container - Fresh-Pak brand. 1 unit per case
Food·121 affected·Dec 19, 2017
High RiskFDA
New Punjab Sweets Inc.
Mixed Sweets- variety 1 lb. clear plastic clamshell containers.
Food·0 affected·Dec 19, 2017
CriticalFDA
Kotecha Brothers, Llc.
Haldiram's Fresh Paneer Traditional Indian Soft Cottage Cheese, Net Weight 800g (28.2 oz)
Dairy·45 affected·Dec 19, 2017
CriticalFDA
Fresh Pak, Inc.
3lb Bag Dice Red Apples - no brand. 4 units per case
Food·440 affected·Dec 19, 2017
High RiskFDA
New Punjab Sweets Inc.
Namak Para 1 lb. clear plastic clamshell containers.
Food·25 affected·Dec 19, 2017
CriticalFDA
Fresh Pak, Inc.
5/2.5oz Slice Apples w/ grapes bags in clamshell - Aunt Mid s brand. 6 units per case
Food·108 affected·Dec 19, 2017
CriticalFDA
Fresh Pak, Inc.
9oz Slice Apples Container - Fresh-Pak brand. 1 unit per case
Food·114 affected·Dec 19, 2017
CriticalFDA
Fresh Pak, Inc.
5/2.2oz Slice Apple Bags in clamshell - Aunt Mid s Michigan Apples brand. 6 units per case
Food·2,658 affected·Dec 19, 2017
High RiskFDA
New Punjab Sweets Inc.
Badusha, 1 lb. clear plastic clamshell containers.
Food·10 affected·Dec 19, 2017
High RiskFDA
Unichem Pharmaceuticals Usa Inc
Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, M...
Oral Drugs·96,876 affected·Dec 19, 2017
Medium RiskFDA
Perkinelmer Health Sciences, Inc.
PerkinElmer 226 Sample Collection Device
Medical Devices·164,952 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
Diagnostic Devices·72,730 affected·Dec 19, 2017
High RiskFDA
Cook Inc.
Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertili...
Medical Devices·1,900 affected·Dec 19, 2017
RecallFDA
Livanova Usa
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, ...
Medical Devices·16 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
Diagnostic Devices·71,640 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic
Diagnostic Devices·1,980 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
Diagnostic Devices·3,122 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
Diagnostic Devices·18 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic
Diagnostic Devices·358 affected·Dec 19, 2017
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1)...
Medical Implants·951 affected·Dec 19, 2017
High RiskFDA
Cook Inc.
Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-572900, Global Product Number: G17946 Product Usage: Us...
Medical Devices·57 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic
Diagnostic Devices·5,040 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic
Diagnostic Devices·20 affected·Dec 19, 2017
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Eve...
Medical Implants·951 affected·Dec 19, 2017
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Product No. DVAB1D1); EXPANSION: ...
Medical Implants·951 affected·Dec 19, 2017
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB...
Medical Implants·951 affected·Dec 19, 2017
High RiskFDA
Deroyal Industries Inc
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine...
Surgical Devices·226 affected·Dec 19, 2017
High RiskFDA
Cook Inc.
1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Cathet...
Surgical Devices·473 affected·Dec 19, 2017
CriticalFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia AF MRI VR SureScan ICD DF1 (Product No...
Medical Implants·951 affected·Dec 19, 2017
CriticalFDA
Ventana Medical Systems Inc
CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic
Diagnostic Devices·748 affected·Dec 19, 2017
High RiskFDA
Nipro Medical Corporation
Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. ...
Medical Devices·307,944 affected·Dec 19, 2017
High RiskFDA
Cook Inc.
Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product Number: G18022 Product Usage: Used to place in vit...
Surgical Devices·21 affected·Dec 19, 2017
High RiskFDA
Ingles Markets
Frozen Buttermilk Biscuits 25 oz. bag (12 count) and 44 oz. bag (20 count)
Dairy·161 affected·Dec 18, 2017
CriticalFDA
Gel Spice Co, Inc.
Spice Supreme Beef Flavored Bouillon Cubes 1.7 oz (48 g) and NET WT. 3-1/2 OZ (98 g) 25 Count
Meat & Poultry·403 affected·Dec 18, 2017