January 31, 2024Medical DevicesFDA
C.R. Bard Inc recalls Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000
Hazard: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
January 31, 2024Medical DevicesFDA
C.R. Bard Inc recalls Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180
Hazard: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
January 31, 2024Medical DevicesFDA
C.R. Bard Inc recalls Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160
Hazard: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
January 31, 2024Medical DevicesFDA
C.R. Bard Inc recalls Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140
Hazard: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
January 31, 2024Medical DevicesFDA
C.R. Bard Inc recalls Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120
Hazard: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
January 31, 2024Medical DevicesFDA
C.R. Bard Inc recalls Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100
Hazard: BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
January 31, 2024Medical DevicesFDA
KENT IMAGING, INC. recalls Snapshot NIR, REF: KD204
Hazard: Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
January 31, 2024Medical DevicesFDA
Ossur H / F recalls Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Hazard: Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may experience loss of support that can lead to a fall and potential injury.
January 31, 2024Medical DevicesFDA
Beckman Coulter, Inc. recalls iQ Waste Well Adapter, Part Number: 700-3393
Hazard: Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
January 31, 2024Medical DevicesFDA
Beckman Coulter, Inc. recalls REV 2 Flowcell Capsule Spare, Part Number: C04154
Hazard: Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
January 31, 2024Medical DevicesFDA
Beckman Coulter, Inc. recalls iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e)
Hazard: Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
January 31, 2024Medical DevicesFDA
Beckman Coulter, Inc. recalls Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
Hazard: Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
January 31, 2024Medical DevicesFDA
Phadia Ab recalls EliA GBM Wells, Material Number 14551401, for Phadia 250, 2500, and 5000. In vitro diagnostic
Hazard: Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.
January 31, 2024Medical DevicesFDA
Hologic, Inc. recalls PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully au
Hazard: Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
January 31, 2024Medical DevicesFDA
SEDECAL SA recalls Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm.
Hazard: Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
January 31, 2024Medical DevicesFDA
Medtronic Neuromodulation recalls Model A710 Intellis Clinician Programmer Application, version 2.0.97
Hazard: Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.
January 31, 2024Medical DevicesFDA
Medtronic Inc. recalls Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Hazard: During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.
January 31, 2024Medical DevicesFDA
Accure Acne, Inc recalls Accure Laser System, Model: PFMS00004
Hazard: Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue, which may cause blistering.
January 31, 2024Medical DevicesFDA
Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S. recalls REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, STERILER, CE 2292
Hazard: Sterility of Ultrasound gel can not be guaranteed.
January 31, 2024Medical DevicesFDA
Tornier, Inc recalls Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
Hazard: The incorrect device is contained in the labeled package.
January 31, 2024Medical DevicesFDA
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Prod
Hazard: Affected lots may experience increased calibration failures or an increase in falsely elevated results.
January 24, 2024Medical DevicesFDA
Getinge Usa Sales Inc recalls Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Number
Hazard: A potential for a light system to fall in the operating room.
January 24, 2024Medical DevicesFDA
Getinge Usa Sales Inc recalls Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD5
Hazard: A potential for a light system to fall in the operating room.
January 24, 2024Medical DevicesFDA
Getinge Usa Sales Inc recalls Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C,
Hazard: A potential for a light system to fall in the operating room.
January 24, 2024Medical DevicesFDA
Getinge Usa Sales Inc recalls Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722
Hazard: A potential for a light system to fall in the operating room.
January 24, 2024Medical DevicesFDA
Getinge Usa Sales Inc recalls Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3
Hazard: A potential for a light system to fall in the operating room.
January 24, 2024Medical DevicesFDA
Getinge Usa Sales Inc recalls Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, X
Hazard: A potential for a light system to fall in the operating room.
January 24, 2024Medical DevicesFDA
Getinge Usa Sales Inc recalls Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C
Hazard: A potential for a light system to fall in the operating room.
January 24, 2024Medical DevicesFDA
Getinge Usa Sales Inc recalls Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD5675
Hazard: A potential for a light system to fall in the operating room.
January 24, 2024Medical DevicesFDA
Getinge Usa Sales Inc recalls Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB
Hazard: A potential for a light system to fall in the operating room.