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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How to report to FDA →68,659 recalls
High RiskFDA
Anhui Welcome Foreign Trade Co.,ltd.
Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Chinese writing)Int...
Ophthalmic Drugs63,750 affectedAug 12, 2021
CriticalFDA
Amtec Sales Inc
EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) ...
Medical Devices34,586 affectedAug 12, 2021
High RiskFDA
Rmh Foods
Gordon Choice Deli Style Tuna Salad, Refrigerated, 4 Lb. retail unit, 2 4 Lb. retail units per wholesale case. Wholesale case labeled a...
Meat & Poultry583 affectedAug 11, 2021
CriticalFDA
Frito-lay, Inc. Headquarters
Wavy Lay s Original Potato Chips UPC 0 28400 04380 9 packaged in flexible bag
Snacks & Candy36 affectedAug 11, 2021
High RiskFDA
Granules Usa, Inc.
Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Villa...
Oral Drugs11,450,000 affectedAug 11, 2021
CriticalFDA
Ebay Seller - John Nguyen
Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108
Drugs35 affectedAug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-se...
Diagnostic Devices12 affectedAug 11, 2021
High RiskFDA
Philips North America Llc
SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system...
Diagnostic Devices198 affectedAug 11, 2021
High RiskFDA
Hill-rom, Inc.
LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combin...
Medical Devices0 affectedAug 11, 2021
CriticalFDA
Red Medical Supplies
EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
Medical Devices3,000 affectedAug 11, 2021
High RiskFDA
Cypress Medical Products Llc
McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121
Medical Devices1 affectedAug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-...
Diagnostic Devices147 affectedAug 11, 2021
High RiskFDA
Hill-rom, Inc.
LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily adjust/control the center of gravity ...
Medical Devices9 affectedAug 11, 2021
CriticalFDA
Red Medical Supplies
EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
Medical Devices2,000 affectedAug 11, 2021
CriticalFDA
Red Medical Supplies
EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
Medical Devices639 affectedAug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sect...
Diagnostic Devices1,517 affectedAug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-se...
Diagnostic Devices266 affectedAug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-...
Diagnostic Devices228 affectedAug 11, 2021
High RiskFDA
Hill-rom, Inc.
Stretch Leveller Model Number: 3156200 - The combination of this products allows the user to easily adjust/control the center of gravity ...
Medical Devices122 affectedAug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross...
Diagnostic Devices99 affectedAug 11, 2021
High RiskFDA
Philips North America Llc
Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce c...
Diagnostic Devices42 affectedAug 11, 2021
High RiskFDA
Th Foods Inc
Crunchmaster Multi Grain Baked Gluten-Free Crackers 5-Seed Sesame, Amaranth, Flax, Chia & Quinoa 20 oz. UPC Code: 8-79890-00220-9
Bakery & Grains7,056 affectedAug 10, 2021
CriticalFDA
Ballreich Snack Food Company, Llc
Barbeque Marcelled Potato Chips Ballreich Snack Food Company 1.5, 2.5, and 7 ounce flexible plastic packaging 1.5 ounce/72 case, 2.75 oun...
Snacks & Candy12,995 affectedAug 10, 2021
High RiskFDA
Taylor Farms Retail, Inc.
Wegmans Sunflower Crunch Chopped Salad Kit: Includes Green Cabbage, Green Leaf Lettuce, Sunflower Seeds, Red Cabbage, Carrot, Kale, Uncur...
Produce111 affectedAug 10, 2021
CriticalFDA
Sterrx, Llc
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Platt...
Injectable Drugs1,098 affectedAug 10, 2021
High RiskFDA
Sterrx, Llc
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Platt...
Injectable Drugs3,378 affectedAug 10, 2021
High RiskFDA
Roi Cps Llc
REGARD Vitrectomy Tray
Medical Devices22 affectedAug 10, 2021
High RiskFDA
Roi Cps Llc
REGARD Ear Tray
Medical Devices44 affectedAug 10, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation t...
Surgical Devices5 affectedAug 10, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation t...
Surgical Devices6 affectedAug 10, 2021
High RiskFDA
Roi Cps Llc
REGARD Basic Cataract tray
Medical Devices126 affectedAug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of pa...
Medical Devices13,320 affectedAug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use for use with the Outlook Safety Infusion System and/or Horizon NX...
Medical Devices940 affectedAug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for...
Medical Devices978,876 affectedAug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
Outlook Pump Primary Administration Set w/ micro Tubing for Epidural Administration-single use, for use with the Outlook Safety Infusion ...
Medical Devices1,080 affectedAug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use, for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion...
Medical Devices768 affectedAug 10, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation...
Surgical Devices2 affectedAug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of ...
Medical Devices12,216 affectedAug 10, 2021
High RiskFDA
Roi Cps Llc
REGARD Newborn Tray
Medical Devices12 affectedAug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion ...
Medical Devices1,752 affectedAug 10, 2021
High RiskFDA
Roi Cps Llc
REGARD Core Biopsy Tray
Medical Devices1,200 affectedAug 10, 2021
High RiskFDA
Roi Cps Llc
REGARD Ultrasound Tray
Medical Devices240 affectedAug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump ...
Medical Devices1,960 affectedAug 10, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation t...
Surgical Devices2 affectedAug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use, for use with the Outlook Safety Infusion System and/or Hor...
Medical Devices336 affectedAug 10, 2021
High RiskFDA
Roi Cps Llc
REGARD Stereotactic Tray
Medical Devices175 affectedAug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of pare...
Medical Devices200 affectedAug 10, 2021
High RiskFDA
B. Braun Medical, Inc.
10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for...
Medical Devices55,584 affectedAug 10, 2021