Browse recalls
Issuing authority: US FDA — Medical Devices
- 2023-11-17 · US FDA — Medical DevicesClass I
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) syst - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511 - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) ER LACERATION TRAY - SNAG FREE, REF SUT12825; b) LACERATION T - 2023-11-15 · US FDA — Medical DevicesClass I
Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSE - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) GYN LAPAROSCOPY, REF CDS984900M; b) GYN LAPAROSCOPY CDS, REF - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR C - 2023-11-15 · US FDA — Medical DevicesClass II
Landauer microSTARii reader, Medical Dosimetry System, Model Numbers: 18000-000/18001-000/18007-000 - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ90 - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) C L PREP, REF DYNJ69664; b) DMEK PREP PACK, REF DYNJ81659A; - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936; b) PORT REMOVAL PACK, REF D - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939 - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE Kits, trays, and packs labeled as follows: a) DIALYSIS FISTULA KIT, REF DYNDC3106, b) ENDO KIT, REF DYKE134 - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) TRACH CARE KIT, REF DYND40589; b) TRACH CARE KIT, REF DYNDA30 - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, R - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550 - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KI - 2023-11-15 · US FDA — Medical DevicesClass II
The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A - 2023-11-15 · US FDA — Medical DevicesClass I
Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYN - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ688 - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G; b) ABDOMEN PA - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT2121 - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION - 2023-11-15 · US FDA — Medical DevicesClass I
Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271 - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, - 2023-11-15 · US FDA — Medical DevicesClass I
MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545 - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W - 2023-11-15 · US FDA — Medical DevicesClass II
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional - 2023-11-15 · US FDA — Medical DevicesClass I
Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NUR - 2023-11-15 · US FDA — Medical DevicesClass I
Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010 - 2023-11-14 · US FDA — Medical DevicesClass II
BD Recanalization System, REF: BDRECANSYSTEM - 2023-11-13 · US FDA — Medical DevicesClass II
Medtronic SynchroMed II, Model 8637-20, Programmable pump - 2023-11-13 · US FDA — Medical DevicesClass II
Medtronic SynchroMed II, Model 8637-40, Programmable pump - 2023-11-13 · US FDA — Medical DevicesClass II
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 an - 2023-11-10 · US FDA — Medical DevicesClass II
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R - 2023-11-10 · US FDA — Medical DevicesClass II
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R - 2023-11-10 · US FDA — Medical DevicesClass II
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL - 2023-11-10 · US FDA — Medical DevicesClass II
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP - 2023-11-07 · US FDA — Medical DevicesClass II
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are inte - 2023-11-07 · US FDA — Medical DevicesClass II
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Imp - 2023-11-07 · US FDA — Medical DevicesClass II
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator - 2023-11-07 · US FDA — Medical DevicesClass II
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body - 2023-11-07 · US FDA — Medical DevicesClass II
Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the - 2023-11-07 · US FDA — Medical DevicesClass II
Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Imp - 2023-11-07 · US FDA — Medical DevicesClass II
Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the - 2023-11-07 · US FDA — Medical DevicesClass II
The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator - 2023-11-07 · US FDA — Medical DevicesClass II
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Ca - 2023-11-06 · US FDA — Medical DevicesClass II
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through - 2023-11-03 · US FDA — Medical DevicesClass II
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree - 2023-11-03 · US FDA — Medical DevicesClass II
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the biliary tree - 2023-11-03 · US FDA — Medical DevicesClass II
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor - 2023-11-03 · US FDA — Medical DevicesClass II
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree - 2023-11-03 · US FDA — Medical DevicesClass II
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree - 2023-11-03 · US FDA — Medical DevicesClass II
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree - 2023-11-03 · US FDA — Medical DevicesClass II
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree - 2023-11-01 · US FDA — Medical DevicesClass II
Atrium Oasis Drain Single W / AC, Part No. 3600-100 - 2023-11-01 · US FDA — Medical DevicesClass I
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 3 - 2023-10-31 · US FDA — Medical DevicesClass II
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103 - 2023-10-31 · US FDA — Medical DevicesClass II
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205 - 2023-10-31 · US FDA — Medical DevicesClass II
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP - 2023-10-31 · US FDA — Medical DevicesClass II
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 - 2023-10-31 · US FDA — Medical DevicesClass II
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104 - 2023-10-26 · US FDA — Medical DevicesClass II
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to - 2023-10-26 · US FDA — Medical DevicesClass II
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to - 2023-10-25 · US FDA — Medical DevicesClass II
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy S - 2023-10-25 · US FDA — Medical DevicesClass II
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accele - 2023-10-25 · US FDA — Medical DevicesClass II
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear - 2023-10-25 · US FDA — Medical DevicesClass II
Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S - 2023-10-25 · US FDA — Medical DevicesClass II
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear - 2023-10-25 · US FDA — Medical DevicesClass II
CD11b APC: ASR, REF: 340936, and CE, REF: 333143 - 2023-10-25 · US FDA — Medical DevicesClass II
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Li - 2023-10-25 · US FDA — Medical DevicesClass II
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Ac - 2023-10-19 · US FDA — Medical DevicesClass II
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX) - 2023-10-17 · US FDA — Medical DevicesClass II
Lugol s Iodine Solution 500ML, Part Number 624-71 - 2023-10-17 · US FDA — Medical DevicesClass II
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, In - 2023-10-16 · US FDA — Medical DevicesClass II
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE - 2023-10-16 · US FDA — Medical DevicesClass I
Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Ster - 2023-10-16 · US FDA — Medical DevicesClass II
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE - 2023-10-16 · US FDA — Medical DevicesClass II
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE - 2023-10-12 · US FDA — Medical DevicesClass II
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6 - 2023-10-11 · US FDA — Medical DevicesClass I
VariSoft infusion set, Model Number 1002828 - 2023-10-11 · US FDA — Medical DevicesClass II
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, re - 2023-10-10 · US FDA — Medical DevicesClass II
VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0 - 2023-10-10 · US FDA — Medical DevicesClass II
VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0 - 2023-10-10 · US FDA — Medical DevicesClass II
VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0 - 2023-10-09 · US FDA — Medical DevicesClass II
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 - 2023-10-09 · US FDA — Medical DevicesClass II
Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiati - 2023-10-09 · US FDA — Medical DevicesClass II
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncolo - 2023-10-09 · US FDA — Medical DevicesClass II
MED-810A Zemits NDPrime Laser products - 2023-10-06 · US FDA — Medical DevicesClass II
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation - 2023-10-05 · US FDA — Medical DevicesClass II
MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK - 2023-10-04 · US FDA — Medical DevicesClass II
BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533 - 2023-10-02 · US FDA — Medical DevicesClass II
The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology - 2023-10-02 · US FDA — Medical DevicesClass II
STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values. - 2023-09-29 · US FDA — Medical DevicesClass II
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 0002434500 - 2023-09-29 · US FDA — Medical DevicesClass II
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004