Browse recalls
Issuing authority: US FDA — Medical Devices
- 2024-07-17 · US FDA — Medical DevicesClass II
Power Express, REF B90918 - 2024-07-17 · US FDA — Medical DevicesClass II
Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 - 2024-07-17 · US FDA — Medical DevicesClass II
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spe - 2024-07-16 · US FDA — Medical DevicesClass I
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD S - 2024-07-16 · US FDA — Medical DevicesClass III
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic - 2024-07-12 · US FDA — Medical DevicesClass II
GE Healthcare Proteus XR/a, stationary X-Ray System, Model/Catalog Numbers: 1) 2259973; 2) 2259988; 3) 2266999; - 2024-07-10 · US FDA — Medical DevicesClass II
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in sampl - 2024-07-10 · US FDA — Medical DevicesClass II
Guidewire 70cm x 1mm (0.038 ) REF 5583705 These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lu - 2024-07-10 · US FDA — Medical DevicesClass II
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; - 2024-07-03 · US FDA — Medical DevicesClass II
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 - 2024-07-02 · US FDA — Medical DevicesClass II
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A - 2024-06-28 · US FDA — Medical DevicesClass II
IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicate - 2024-06-28 · US FDA — Medical DevicesClass II
IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicate - 2024-06-28 · US FDA — Medical DevicesClass II
Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300 - 2024-06-27 · US FDA — Medical DevicesClass II
Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000- - 2024-06-26 · US FDA — Medical DevicesClass II
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventiona - 2024-06-26 · US FDA — Medical DevicesClass II
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventiona - 2024-06-20 · US FDA — Medical DevicesClass II
Cepheid, Sample Collection Device, Part: 900-0370 - 2024-06-19 · US FDA — Medical DevicesClass II
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunctio - 2024-06-18 · US FDA — Medical DevicesClass II
CRANIOTOMY PACK, Pack Number DYNJ46552O - 2024-06-17 · US FDA — Medical DevicesClass II
OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administra - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) a - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) adm - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administratio - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administrati - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) a - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for intravenous (IV) adm - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) ad - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pump for intravenous (IV) admini - 2024-06-17 · US FDA — Medical DevicesClass II
OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration o - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) a - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for intravenous (IV) - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV - 2024-06-17 · US FDA — Medical DevicesClass II
Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusion pump for intravenous (IV) ad - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administ - 2024-06-17 · US FDA — Medical DevicesClass II
Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV) - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Ima - 2024-06-14 · US FDA — Medical DevicesClass II
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, - 2024-06-14 · US FDA — Medical DevicesClass II
Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Softwar - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emi - 2024-06-14 · US FDA — Medical DevicesClass II
Discrete photometric chemistry analyzer for clinical use. - 2024-06-14 · US FDA — Medical DevicesClass II
Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imagi - 2024-06-14 · US FDA — Medical DevicesClass II
Alinity hq Analyzer, REF: 09P68-01 - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magne - 2024-06-14 · US FDA — Medical DevicesClass II
Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging Syste - 2024-06-14 · US FDA — Medical DevicesClass II
Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use on - 2024-06-14 · US FDA — Medical DevicesClass II
Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: P - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System - 2024-06-14 · US FDA — Medical DevicesClass II
Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Ma - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nucle - 2024-06-14 · US FDA — Medical DevicesClass II
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 - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System - 2024-06-14 · US FDA — Medical DevicesClass II
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 - 2024-06-14 · US FDA — Medical DevicesClass II
SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System - 2024-06-13 · US FDA — Medical DevicesClass II
Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus - 2024-06-13 · US FDA — Medical DevicesClass II
Hookup Model/Catalog Number: 2-8-540 Product Description: Hookups provide the interface between an Advantage Plus" A - 2024-06-13 · US FDA — Medical DevicesClass II
Hookup Model/Catalog Number: 2-8-540HAN Product Description: Hookups provide the interface between an Advantage Plus - 2024-06-05 · US FDA — Medical DevicesClass II
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in sampl - 2024-06-04 · US FDA — Medical DevicesClass II
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical - 2024-06-04 · US FDA — Medical DevicesClass II
iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Ligh - 2024-06-04 · US FDA — Medical DevicesClass II
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) - 2024-06-03 · US FDA — Medical DevicesClass II
Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of - 2024-06-03 · US FDA — Medical DevicesClass II
QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecu - 2024-06-03 · US FDA — Medical DevicesClass II
Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), R - 2024-05-31 · US FDA — Medical DevicesClass II
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of sa - 2024-05-31 · US FDA — Medical DevicesClass II
The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Leng - 2024-05-29 · US FDA — Medical DevicesClass II
Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular P - 2024-05-29 · US FDA — Medical DevicesClass II
Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog - 2024-05-29 · US FDA — Medical DevicesClass I
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes - 2024-05-23 · US FDA — Medical DevicesClass II
Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399 - 2024-05-23 · US FDA — Medical DevicesClass II
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910 - 2024-05-23 · US FDA — Medical DevicesClass II
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900 - 2024-05-22 · US FDA — Medical DevicesClass II
2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-9 - 2024-05-17 · US FDA — Medical DevicesClass II
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e - 2024-05-16 · US FDA — Medical DevicesClass II
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY - 2024-05-14 · US FDA — Medical DevicesClass III
VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the - 2024-05-14 · US FDA — Medical DevicesClass II
VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged - 2024-05-13 · US FDA — Medical DevicesClass II
BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ - 2024-05-13 · US FDA — Medical DevicesClass II
BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 1 - 2024-05-10 · US FDA — Medical DevicesClass II
MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), - 2024-05-09 · US FDA — Medical DevicesClass II
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual - 2024-05-09 · US FDA — Medical DevicesClass II
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasoun - 2024-05-02 · US FDA — Medical DevicesClass II
GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW - 2024-05-02 · US FDA — Medical DevicesClass II
BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES - 2024-04-30 · US FDA — Medical DevicesClass I
ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick Reference Guide (QRG - 2024-04-29 · US FDA — Medical DevicesClass I
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS - 2024-04-29 · US FDA — Medical DevicesClass I
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U - 2024-04-29 · US FDA — Medical DevicesClass I
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U - 2024-04-26 · US FDA — Medical DevicesClass II
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients - 2024-04-24 · US FDA — Medical DevicesClass II
Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software - 2024-04-24 · US FDA — Medical DevicesClass II
MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display - 2024-04-24 · US FDA — Medical DevicesClass II
Brand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20 pores/inch) Model/Catalog Number: EC20T20VI Software