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
CriticalFDA
Megadyne Medical Products, Inc.
Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode ...
Medical Devices·2,584 affected·Jun 17, 2024
High RiskFDA
B. Braun Medical, Inc.
Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication ...
Medical Devices·2,160 affected·Jun 17, 2024
High RiskFDA
B. Braun Medical, Inc.
Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of ...
Medical Devices·7,360 affected·Jun 17, 2024
High RiskFDA
B. Braun Medical, Inc.
Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of...
Medical Devices·1,325,700 affected·Jun 17, 2024
High RiskFDA
B. Braun Medical, Inc.
Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of...
Medical Devices·1,152 affected·Jun 17, 2024
High RiskFDA
B. Braun Medical, Inc.
Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for intravenous (IV) administration of me...
Medical Devices·3,624 affected·Jun 17, 2024
High RiskFDA
B. Braun Medical, Inc.
Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of m...
Medical Devices·100 affected·Jun 17, 2024
High RiskFDA
Medtronic Neuromodulation
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handse...
Medical Devices·211 affected·Jun 17, 2024
High RiskFDA
B. Braun Medical, Inc.
Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pump for intravenous (IV) administration of medic...
Medical Devices·431,999 affected·Jun 17, 2024
High RiskFDA
B. Braun Medical, Inc.
OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Mo...
Medical Devices·236,208 affected·Jun 17, 2024
High RiskFDA
Abbott Diagnostics Technologies As
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Medical Devices·5 affected·Jun 17, 2024
High RiskFDA
B. Braun Medical, Inc.
Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of ...
Medical Devices·42,028 affected·Jun 17, 2024
High RiskFDA
B. Braun Medical, Inc.
Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for intravenous (IV) administration o...
Medical Devices·33,065 affected·Jun 17, 2024
High RiskFDA
B. Braun Medical, Inc.
Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV) administration ...
Medical Devices·6,843,513 affected·Jun 17, 2024
High RiskFDA
B. Braun Medical, Inc.
Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of m...
Medical Devices·9,504 affected·Jun 17, 2024
High RiskFDA
Roi Cps Llc
Regard Kit containing the Microtek decanter
Medical Devices·78 affected·Jun 17, 2024
High RiskFDA
B. Braun Medical, Inc.
Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medicat...
Medical Devices·109,464 affected·Jun 17, 2024
High RiskFDA
B. Braun Medical, Inc.
Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV) administration o...
Medical Devices·59,811 affected·Jun 17, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Medical Devices·2,528 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, ...
Medical Devices·834 affected·Jun 14, 2024
High RiskFDA
B Braun Medical Inc
Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 871303...
Medical Devices·9,943 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
Medical Devices·308 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed to...
Medical Devices·123 affected·Jun 14, 2024
High RiskFDA
Beckman Coulter, Inc.
Discrete photometric chemistry analyzer for clinical use.
Medical Devices·59 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imaging System
Medical Devices·23 affected·Jun 14, 2024
High RiskFDA
Abbott Laboratories
Alinity hq Analyzer, REF: 09P68-01
Medical Devices·816 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Ima...
Medical Devices·1,522 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
Medical Devices·469 affected·Jun 14, 2024
High RiskFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Medical Devices·1 affected·Jun 14, 2024
High RiskFDA
B Braun Medical Inc
Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space...
Medical Devices·1,663 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use only
Medical Devices·6 affected·Jun 14, 2024
High RiskFDA
B Braun Medical Inc
Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, In...
Medical Devices·930 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
Medical Devices·206 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
Medical Devices·81 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance ...
Medical Devices·1,607 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Reson...
Medical Devices·1,817 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1; Nuclear Magneti...
Medical Devices·484 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System
Medical Devices·3 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16.0_V03, HD23.0_V0...
Medical Devices·0 affected·Jun 14, 2024
High RiskFDA
Ge Medical Systems, Llc
SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
Medical Devices·23 affected·Jun 14, 2024
High RiskFDA
Totally Cool, Inc.
Marco Turkish Mocha Ice Cream 16 fl oz/1 pint, UPC 860001992885. Packaged in paper containers, 8 containers per case.
Dairy·15,541 affected·Jun 13, 2024
High RiskFDA
Totally Cool, Inc.
Dolcezza Peanut Butter Stracciatella Gelato 16 fl oz/1 pint, UPC 857838006090. Packaged in paper containers, 8 containers per case.
Dairy·2,355 affected·Jun 13, 2024
High RiskFDA
Totally Cool, Inc.
Marco Dulce De Leche & Cookies Ice Cream 16 fl oz/1 pint, UPC 860006880514. Packaged in paper containers, 8 containers per case.
Dairy·17,633 affected·Jun 13, 2024
High RiskFDA
Totally Cool, Inc.
Dolcezza Stracciatella Gelato 16 fl oz/1 pint, UPC 857838006120. Packaged in paper containers, 8 containers per case.
Food·19,394 affected·Jun 13, 2024
High RiskFDA
Totally Cool, Inc.
Dolcezza Sugar Cookie Dough Gelato 16 fl oz/1 pint, UPC 857838006618. Packaged in paper containers, 8 containers per case.
Bakery & Grains·2,145 affected·Jun 13, 2024
High RiskFDA
Totally Cool, Inc.
Chipwich Vanilla Chocolate Chip Ice Cream Sandwich 4 fl oz sold as 3-pack, 10-pack, and 24 (single serve) pack. Sandwiches individually w...
Dairy·113,315 affected·Jun 13, 2024
High RiskFDA
Totally Cool, Inc.
The Frozen Farmer Santa's Cookies Ice Cream Cookie Sandwich the Elf On the Shelf 4 fl oz UPC 850023398178. Individually wrapped in plasti...
Dairy·26,453 affected·Jun 13, 2024
High RiskFDA
Totally Cool, Inc.
LaSalle Chocolate Ice Cream 16 fl oz/1 pint, UPC 671891374114. Packaged in paper containers, 8 containers per case.
Dairy·5,604 affected·Jun 13, 2024