Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 95 of 548
FDA Devices Moderate Dec 13, 2023
EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens.
Staar Surgical Company
FDA Devices Moderate Dec 13, 2023
Stay Safe Cap
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Dec 13, 2023
EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens.
Staar Surgical Company
FDA Devices Moderate Dec 13, 2023
DRX Revolution Mobile X-Ray System
Carestream Health, Inc.
FDA Devices Moderate Dec 13, 2023
Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catal…
Integra LifeSciences Corp.
FDA Devices Moderate Dec 13, 2023
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Atrium Medical Corporation
FDA Devices Moderate Dec 13, 2023
ProCuity bed series, model number 3009, item number: 3009PX-LE-400.
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Dec 13, 2023
CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
CardioQuip, LLC
FDA Devices Moderate Dec 13, 2023
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
AURIS HEALTH INC
FDA Devices Moderate Dec 13, 2023
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Vyaire Medical
FDA Devices Moderate Dec 13, 2023
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to dete…
CooperSurgical, Inc.
FDA Devices Moderate Dec 13, 2023
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Elekta, Inc.
FDA Devices Moderate Dec 13, 2023
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate strictures of the biliary tree
Wilson-Cook Medical Inc.
FDA Devices Moderate Dec 13, 2023
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
Heartware, Inc.
FDA Devices Moderate Dec 13, 2023
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
Atrium Medical Corporation
FDA Devices Critical Dec 13, 2023
Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming …
B. Braun Medical, Inc.
FDA Devices Moderate Dec 13, 2023
STAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro diagnostic for blood ketone values.
Stanbio Laboratory, LP
FDA Devices Moderate Dec 13, 2023
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
Wilson-Cook Medical Inc.
FDA Devices Moderate Dec 13, 2023
Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation
Liberty Medical Solutions, LLC
FDA Devices Moderate Dec 13, 2023
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Atrium Medical Corporation
FDA Devices Moderate Dec 13, 2023
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Con…
BioFire Diagnostics, LLC
FDA Devices Moderate Dec 13, 2023
CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hystero…
CooperSurgical, Inc.
FDA Devices Moderate Dec 13, 2023
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
Heartware, Inc.
FDA Devices Moderate Dec 13, 2023
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
Heartware, Inc.
FDA Devices Moderate Dec 13, 2023
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Abiomed, Inc.
FDA Devices Moderate Dec 13, 2023
ProCuity bed series, model number 3009, item number: 3009PX-L-100.
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Dec 13, 2023
ProCuity bed series, model number 3009, item number: 3009PX-ZM-450.
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Dec 13, 2023
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree
Wilson-Cook Medical Inc.
FDA Devices Moderate Dec 13, 2023
CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
CardioQuip, LLC
FDA Devices Moderate Dec 13, 2023
ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600.
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Dec 13, 2023
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Elekta, Inc.
FDA Devices Moderate Dec 13, 2023
NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
Thor Photomedicine Ltd
FDA Devices Moderate Dec 13, 2023
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
Integra LifeSciences Corp.
FDA Devices Moderate Dec 13, 2023
ProCuity bed series, model number 3009, item number: 3009PX-LEX-400.
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Dec 13, 2023
Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
AURIS HEALTH INC
FDA Devices Moderate Dec 13, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
Staar Surgical Company
FDA Devices Moderate Dec 13, 2023
NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176
Thor Photomedicine Ltd
FDA Devices Moderate Dec 13, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens.
Staar Surgical Company
FDA Devices Moderate Dec 13, 2023
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the biliary tree
Wilson-Cook Medical Inc.
FDA Devices Moderate Dec 13, 2023
ProCurity bed series, model number 3009, item number: 3009PX-ZX-450.
Stryker Medical Division of Stryker Corporation
FDA Devices Moderate Dec 13, 2023
DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS …
Encore Medical, LP
FDA Devices Moderate Dec 13, 2023
Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43L, 42A-43M…
IHB OPERATIONS B.V.
FDA Devices Moderate Dec 13, 2023
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Elekta, Inc.
FDA Devices Moderate Dec 13, 2023
Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
Integra LifeSciences Corp.
FDA Devices Moderate Dec 13, 2023
EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
Staar Surgical Company
FDA Devices Moderate Dec 13, 2023
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
Heartware, Inc.
FDA Devices Moderate Dec 13, 2023
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
Heartware, Inc.
FDA Devices Moderate Dec 13, 2023
Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270
Integra LifeSciences Corp.
FDA Devices Moderate Dec 13, 2023
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260
Integra LifeSciences Corp.
FDA Devices Moderate Dec 13, 2023
EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocular lens.
Staar Surgical Company