Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
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
Steris Corporation
Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endos...
Medical Devices·6 affected·Jun 13, 2024
High RiskFDA
Steris Corporation
Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscop...
Medical Devices·37 affected·Jun 13, 2024
High RiskFDA
Baxter Healthcare Corporation
Braun Thermoscan¿ PRO 6000 Ear Thermometer
Medical Devices·265,647 affected·Jun 13, 2024
High RiskFDA
Steris Corporation
Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus" Automated Endos...
Medical Devices·129 affected·Jun 13, 2024
CriticalFDA
Synergetics Inc
BAUSCH+LOMB, I-PACK Injection Kit, REF 18060, for the administration of intravitreal injection (eye)
Medical Devices·14 affected·Jun 12, 2024
High RiskFDA
Boston Scientific Corporation
Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the...
Medical Devices·256 affected·Jun 12, 2024
CriticalFDA
Synergetics Inc
BAUSCH+LOMB, I-PACK Injection Kit with Drape, REF 18061, for the administration of intravitreal injection (eye)
Medical Devices·2 affected·Jun 12, 2024
CriticalFDA
Synergetics Inc
BAUSCH+LOMB, I-PACK Injection Kit with Wire Speculum, REF 18069W, for the administration of intravitreal injection (eye)
Medical Devices·35 affected·Jun 12, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste...
Medical Devices·2,388 affected·Jun 11, 2024
High RiskFDA
Canadian Hospital Specialties Ltd.
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Medical Devices·6,300 affected·Jun 11, 2024
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Customer Procedure Kit ...
Medical Devices·1,753,625 affected·Jun 11, 2024
High RiskFDA
Ethicon Sarl, A Johnson & Johnson Company
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
Medical Devices·450,793 affected·Jun 11, 2024
High RiskFDA
Biofire Diagnostics, Llc
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Medical Devices·24 affected·Jun 10, 2024
High RiskFDA
Biofire Diagnostics, Llc
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
Medical Devices·58 affected·Jun 10, 2024
High RiskFDA
Rygel Advanced Machines D/b/a Omtech Laser
OMTech Desktop Laser Engraver
Medical Devices·641 affected·Jun 7, 2024
CriticalFDA
Smiths Medical Asd Inc.
smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number 101/800/0...
Medical Devices·799,732 affected·Jun 7, 2024
CriticalFDA
Smiths Medical Asd Inc.
smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows: 1) BLUper...
Medical Devices·41,691 affected·Jun 7, 2024
CriticalFDA
Philips North America Llc
SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Num...
Medical Devices·729 affected·Jun 5, 2024