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

Have an unsafe medication, device, or food to report?

Filing a report with the FDA is free and takes a few minutes. Consumer reports drive future recalls and help the agency identify safety patterns.

How to report to FDA →
68,659 recalls
High RiskFDA
Tosoh Bioscience Inc
Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318 The product is intended for In Vitro Diagnostic Use Only for the calib...
Diagnostic Devices·1,485 affected·Mar 5, 2018
High RiskFDA
Ripple Foods Pbc
ripple Chocolate Nutritious Pea Milk; 48 oz. plastic bottle; 8 g Plant Based Protein 30% Less Sugar than Chocolate Milk; 50% More Cal...
Dairy·448 affected·Mar 2, 2018
RecallFDA
Renaissance Lakewood, Llc
Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifescien...
Injectable Drugs·1,277 affected·Mar 2, 2018
High RiskFDA
Beckman Coulter Inc.
BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 80...
Diabetes Devices·2,225 affected·Mar 2, 2018
High RiskFDA
Getinge Disinfection Ab
Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 073401537...
Medical Devices·170 affected·Mar 2, 2018
High RiskFDA
Beckman Coulter Inc.
BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-33...
Medical Devices·5,247 affected·Mar 2, 2018
High RiskFDA
Randox Laboratories Ltd.
Lipase, Catalog number: LI3837; GTIN: 05055273204230 and Catalog number: LI8361; GTIN: 05055273214284 Product Usage: For Professional...
Medical Devices·8 affected·Mar 2, 2018
High RiskFDA
Kuiyi International Inc.
XZB Grilled Crispy Shrimp (20g*20 and 16g*24) UPC Code (16g) 6923006800082
Seafood·399 affected·Mar 1, 2018
CriticalFDA
Weis Markets
Dried Beef Party Rye Dip; Ingredients: Hellman's Mayonaise, Sour Cream, Dried Beef (Cured with Water, Salt, Sugar, Sodium Nitrate, Sodi...
Dairy·300 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
38 cm (15") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Re...
Medical Devices·350 affected·Mar 1, 2018
CriticalFDA
Draeger Medical, Inc.
Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operati...
Respiratory Devices·8 affected·Mar 1, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced N...
Medical Implants·24 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
PROXIMALE - 18 cm (7") Appx 0.92 ml, PUR Smallbore Ext Set, 6-Port NanoClave Manifold w/NanoClave (Purple Rings), Check Valve, Rotating L...
Medical Devices·30 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
40 cm (16") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
Medical Devices·150 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
191 cm (75") Appx 2.9 ml, PVC/PUR Smallbore Bifuse Ext Set w/6-Port NanoClave Manifold w/2 Red Rings, Check Valve, 2 MicroClave Clear, Cl...
Medical Devices·50 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
20 cm (8") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer single use, sterile, non-pyrogenic de...
Medical Devices·81 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer.
Medical Devices·200 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer
Medical Devices·650 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port NanoClave Manifol...
Medical Devices·122 affected·Mar 1, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset ...
Medical Implants·12 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
165 cm (65") PUR Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer a single use, sterile, non-pyrogeni...
Medical Devices·50 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer.
Medical Devices·100 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear
Medical Devices·302 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
216 cm (85") PVC/PUR Smallbore Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, MicroClave Clear, Clamp, Rotating Luer.
Medical Devices·50 affected·Mar 1, 2018
CriticalFDA
Draeger Medical, Inc.
Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in ...
Respiratory Devices·27 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopc...
Medical Devices·100 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
43 cm (17") Smallbore Ext Set w/3-Port NanoClave Manifold, Check Valve, NanoClave, 0.2 Micron Filter, 2 BCV-Clave, Rotating Luer.
Medical Devices·100 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow, Green Rings), NanoClave (Light Blue Ring), Check Va...
Medical Devices·150 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
30 cm (12") PUR Bifuse Ext Set w/3-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer a single use, sterile, non-pyrogenic ...
Medical Devices·100 affected·Mar 1, 2018
High RiskFDA
Biomerieux, Inc.
VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family ...
Diagnostic Devices·5,429 affected·Mar 1, 2018
CriticalFDA
Draeger Medical, Inc.
Fabius Tiro, anesthesia machine, catalog no. 8606000 Product Usage: The products are inhalation anesthesia machines for use in operat...
Respiratory Devices·26 affected·Mar 1, 2018
High RiskFDA
Icu Medical De Mexico, S.a. De C.v.
PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer.
Medical Devices·532 affected·Mar 1, 2018
High RiskFDA
Asr Group International Inc
Tank Truck #2 Sugar Syrup (403764)
Food·50,000 affected·Feb 28, 2018
High RiskFDA
Asr Group International Inc
Tank Truck #1 Sugar Syrup (403763)
Food·50,000 affected·Feb 28, 2018
High RiskFDA
Adams Extract & Spice Llc
Adams Reserve, Fajita Grilling Rub 5.7 oz. Bottle Item Code: 04544, 12 bottles per case
Food·1,836 affected·Feb 28, 2018
High RiskFDA
Asr Group International Inc
Tank Truck Medium Invert Syrup (403777)
Food·50,000 affected·Feb 28, 2018
CriticalFDA
Blue Moose Of Boulder, Llc
All-Natural Ciolo Nut-Free Basil Pesto, 7 oz., plastic container, Item #: 30019.18
Food·504 affected·Feb 28, 2018
RecallFDA
Osmotica Pharmaceutical Corp
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 0...
Oral Drugs·19,664 affected·Feb 28, 2018
High RiskFDA
Zimmer Gmbh
Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496
Medical Devices·0 affected·Feb 28, 2018
High RiskFDA
Vygon U.s.a.
PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.
Medical Devices·16,520 affected·Feb 28, 2018
High RiskFDA
Vygon U.s.a.
PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.
Medical Devices·16,520 affected·Feb 28, 2018
High RiskFDA
Zimmer Gmbh
Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368
Medical Devices·0 affected·Feb 28, 2018
High RiskFDA
Vygon U.s.a.
Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
Medical Devices·16,520 affected·Feb 28, 2018
High RiskFDA
Biomet, Inc.
Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reco...
Medical Implants·634 affected·Feb 28, 2018
High RiskFDA
Vygon U.s.a.
Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.
Medical Devices·16,520 affected·Feb 28, 2018
High RiskFDA
Vygon U.s.a.
Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.
Medical Devices·16,520 affected·Feb 28, 2018
High RiskFDA
Vygon U.s.a.
PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.
Medical Devices·16,520 affected·Feb 28, 2018
High RiskFDA
Plant Devas Inc
Blemish Face Care Kit; Each kit contains: Tea Tree Gel Cleanser 1 fl oz bottle Lemon Thyme Facial Tonic HydroSoul 1 fl oz bottle ...
Beverages·3,653 affected·Feb 27, 2018