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
Zimmer Biomet, Inc.
CPT 12/14 COCR REVISION SIZE 2 180MM prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CR-FLEX PCT FEM C-R MINUS CR-FLEX PCT FEM D-L MINUS CR-FLEX PCT FEM D-R MINUS CR-FLEX PCT FEM E-L MINUS CR-FLEX PCT FEM E-R MINUS CR...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
LPS POROUS FEM IMPLANT SZ G-L LPS PRECOAT FEM IMPLANT SZ G-L This device is indicated for patients with severe knee pain and disability
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CPT 12/14 COCR SIZE 2 EXT prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
LPS FEM IMPLANT SZ H-R This device is indicated for patients with severe knee pain and disability
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
LPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTION FEMORAL D-R LPS OPTION FEMORAL E-L LPS OPTION FEMORA...
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
CR POR FEM HATCP SIZE E/L SIZE F/L Knee Prosthesis
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Medical Implants·13,227 affected·Nov 29, 2017
High RiskFDA
Zimmer Dental Inc
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
Medical Implants·995 affected·Nov 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
NEXGEN LPS-FLEX PRECOAT FEMORAL SIZE E-LT This device is indicated for patients with severe knee pain and disability
Medical Devices·13,227 affected·Nov 29, 2017
High RiskFDA
Jp's Delicacies Llc
Holi Aioli, Lemon Basil 12oz bottle
Food·1,344 affected·Nov 28, 2017
RecallFDA
Teva Pharmaceuticals Usa
Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada B...
Oral Drugs·42,384 affected·Nov 28, 2017
High RiskFDA
Eai-jr286 Inc
Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF ...
Topical Drugs·5,355 affected·Nov 28, 2017
High RiskFDA
Stryker Neurovascular
Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
Surgical Devices·0 affected·Nov 28, 2017
High RiskFDA
H. A. R. Maspeth Corp.
WOLDONG WORLD'S BEST KIMCHI WHOLE CABBAGE KIMCHI PREMIUM 3LBS (1.36kg), UPC: 8 46034 04853 9 and 7LBS (3.17kg), UPC: 846034048546.
Food·3 affected·Nov 27, 2017
High RiskFDA
Spineart Sa
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervic...
Medical Devices·120 affected·Nov 27, 2017
High RiskFDA
Spineart Sa
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervic...
Medical Devices·15 affected·Nov 27, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30...
Surgical Devices·23,904 affected·Nov 27, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days...
Surgical Devices·23,904 affected·Nov 27, 2017
High RiskFDA
Arrow International Inc
Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology Product Usage: ...
Surgical Devices·23,904 affected·Nov 27, 2017
High RiskFDA
Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product Usage: The Arrow¿ CVC...
Surgical Devices·23,904 affected·Nov 27, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 ...
Surgical Devices·23,904 affected·Nov 27, 2017
High RiskFDA
Ethicon, Inc.
DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold clos...
Surgical Devices·20,090 affected·Nov 27, 2017
High RiskFDA
Spineart Sa
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervic...
Medical Devices·54 affected·Nov 27, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for...
Diagnostic Devices·0 affected·Nov 27, 2017
High RiskFDA
Spineart Sa
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervic...
Medical Devices·8 affected·Nov 27, 2017
High RiskFDA
Arrow International Inc
ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central ...
Surgical Devices·23,904 affected·Nov 27, 2017
High RiskFDA
Spineart Sa
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervi...
Medical Devices·9 affected·Nov 27, 2017
High RiskFDA
Arrow International Inc
AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ CVC is indicated to provide short-term (< 30 days) central ve...
Surgical Devices·23,904 affected·Nov 27, 2017
High RiskFDA
United Orthopedic Corporation
U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indic...
Surgical Devices·69 affected·Nov 24, 2017
High RiskFDA
United Orthopedic Corporation
U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthr...
Surgical Devices·14 affected·Nov 24, 2017
High RiskFDA
Colorado Nut Co
Frontier Trail Mix (4 oz. bag), UPC 018142352987. Packaged in Plastic Zip Lock bags. No refrigeration needed.
Food·46,400 affected·Nov 22, 2017
High RiskFDA
Colorado Nut Co
Peanut Delight (8 oz. bag), UPC 018142352512. Packaged in Plastic Zip Lock bags. No refrigeration needed.
Food·1,739 affected·Nov 22, 2017
CriticalFDA
Saranac Brand Foods, Inc.
Saranac Pasta and Seafood Salad 2x10lbs or 2x5lbs plastic tubs.
Seafood·2,070 affected·Nov 22, 2017
High RiskFDA
Colorado Nut Co
Honey Nutty Granola (8 oz. bag), UPC 018142352147. Packaged in Plastic Zip Lock bags. No refrigeration needed.
Bakery & Grains·223 affected·Nov 22, 2017
High RiskFDA
Colorado Nut Co
Oat Bran Nutty Crunch (8 oz. bag), UPC 018142352130. Packaged in Plastic Zip Lock bags. No refrigeration needed.
Food·83 affected·Nov 22, 2017
High RiskFDA
Smiths Medical Asd Inc.
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Medical Devices·58 affected·Nov 22, 2017
RecallFDA
Ecolab Inc
ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/...
Surgical Devices·65 affected·Nov 22, 2017
High RiskFDA
Medical Components, Inc Dba Medcomp
8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter
Surgical Devices·24 affected·Nov 22, 2017
RecallFDA
Ecolab Inc
ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons...
Surgical Devices·65 affected·Nov 22, 2017
High RiskFDA
Apollo Endosurgery Inc
Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that a...
Medical Implants·54 affected·Nov 22, 2017
High RiskFDA
Leclerc Foods Usa
Fit & Active Chocolatey Chip Protein Meal Bars; UPC: 41498 18695; Lot Code: Q209MY; Expiration date: May 24, 2018
Snacks & Candy·2,701 affected·Nov 21, 2017
Medium RiskFDA
Lupin Pharmaceuticals Inc.
Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryl...
Oral Drugs·111,648 affected·Nov 21, 2017
High RiskFDA
Covidien Llc
Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Vent...
Respiratory Devices·15,885 affected·Nov 21, 2017
High RiskFDA
Medica Corporation
Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use...
Diagnostic Devices·392 affected·Nov 21, 2017
High RiskFDA
Horiba Instruments, Inc Dba Horiba Medical
10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
Diagnostic Devices·10 affected·Nov 21, 2017
High RiskFDA
Santa Joy Ornament & Giftware Co
Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various c...
Medical Devices·433,128 affected·Nov 21, 2017