October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Cook Medical Incorporated recalls Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-1
Hazard: Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
October 22, 2025Medical DevicesFDA
Percussionaire Corporation recalls Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual)
Hazard: IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.
October 15, 2025Medical DevicesFDA
Applied Medical Technology Inc recalls NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NRT-06090-I The NutraGlide Nasal Feeding Tub
Hazard: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
October 15, 2025Medical DevicesFDA
Applied Medical Technology Inc recalls NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tub
Hazard: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
October 15, 2025Medical DevicesFDA
Applied Medical Technology Inc recalls NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90, REF E NRT-05090-I The NutraGlide Nasal Feeding Tub
Hazard: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
October 15, 2025Medical DevicesFDA
Applied Medical Technology Inc recalls NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I The NutraGlide Nasal Feeding Tub
Hazard: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
October 15, 2025Medical DevicesFDA
B BRAUN MEDICAL INC recalls Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD J
Hazard: Potential for the lid of the catheter connector to be in the incorrect position.
October 15, 2025Medical DevicesFDA
B BRAUN MEDICAL INC recalls Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga.
Hazard: Potential for the lid of the catheter connector to be in the incorrect position.
October 15, 2025Medical DevicesFDA
B BRAUN MEDICAL INC recalls Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY.
Hazard: Potential for the lid of the catheter connector to be in the incorrect position.
October 15, 2025Medical DevicesFDA
B BRAUN MEDICAL INC recalls Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x
Hazard: Potential for the lid of the catheter connector to be in the incorrect position.
October 15, 2025Medical DevicesFDA
B BRAUN MEDICAL INC recalls ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN
Hazard: Potential for the lid of the catheter connector to be in the incorrect position.
October 15, 2025Medical DevicesFDA
B BRAUN MEDICAL INC recalls PERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x 3-1/2 in. (8.9 cm) - Winged, PER
Hazard: Potential for the lid of the catheter connector to be in the incorrect position.
October 15, 2025Medical DevicesFDA
B BRAUN MEDICAL INC recalls PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 1
Hazard: Potential for the lid of the catheter connector to be in the incorrect position.
October 15, 2025Medical DevicesFDA
B BRAUN MEDICAL INC recalls PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 1
Hazard: Potential for the lid of the catheter connector to be in the incorrect position.
October 15, 2025Medical DevicesFDA
B BRAUN MEDICAL INC recalls PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga.
Hazard: Potential for the lid of the catheter connector to be in the incorrect position.
October 15, 2025Medical DevicesFDA
B BRAUN MEDICAL INC recalls PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged a
Hazard: Potential for the lid of the catheter connector to be in the incorrect position.
October 15, 2025Medical DevicesFDA
B BRAUN MEDICAL INC recalls PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged a
Hazard: Potential for the lid of the catheter connector to be in the incorrect position.
October 15, 2025Medical DevicesFDA
B BRAUN MEDICAL INC recalls PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged an
Hazard: Potential for the lid of the catheter connector to be in the incorrect position.
October 15, 2025Medical DevicesFDA
B BRAUN MEDICAL INC recalls PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and
Hazard: Potential for the lid of the catheter connector to be in the incorrect position.
October 15, 2025Medical DevicesFDA
Inpeco S.A. recalls FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
Hazard: The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.
October 15, 2025Medical DevicesFDA
Inpeco S.A. recalls FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Hazard: The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.
October 15, 2025Medical DevicesFDA
LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegr
Hazard: Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
October 15, 2025Medical DevicesFDA
Beckman Coulter Inc. recalls SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Hazard: Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.
October 15, 2025Medical DevicesFDA
Abiomed, Inc. recalls Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding
Hazard: Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
October 15, 2025Medical DevicesFDA
GE Medical Systems, SCS recalls AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2
Hazard: Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.