April 24, 2024Medical DevicesFDA
Cook Incorporated recalls Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end ca
Hazard: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
April 24, 2024Medical DevicesFDA
Cook Incorporated recalls Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or t
Hazard: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
April 24, 2024Medical DevicesFDA
Cook Incorporated recalls Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular a
Hazard: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
April 24, 2024Medical DevicesFDA
Cook Incorporated recalls Chiba Biopsy Needle - Used for aspiration biopsy. REFERENCE PART NUMBER (RPN) ORDER NUMBER (GPN): 1) DCHN-18-10.0
Hazard: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
April 24, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch
Hazard: The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).
April 24, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch
Hazard: The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).
April 24, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch
Hazard: The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).
April 24, 2024Medical DevicesFDA
SonarMed Inc recalls AW-S035 NEO SONARMED SENSOR 3.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Hazard: The failure to detect the partial obstruction in a 2.5mm sensor.
April 24, 2024Medical DevicesFDA
SonarMed Inc recalls AW-S030 NEO SONARMED SENSOR 3.0MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Hazard: The failure to detect the partial obstruction in a 2.5mm sensor.
April 24, 2024Medical DevicesFDA
SonarMed Inc recalls AW-S025 NEO SONARMED SENSOR 2.5MM. Used in conjunction with SonarMed Monitor for airway monitoring.
Hazard: The failure to detect the partial obstruction in a 2.5mm sensor.
April 24, 2024Medical DevicesFDA
Draeger Medical, Inc. recalls Dr¿ger Perseus A500 Anesthesia Workstation
Hazard: Unexpected shutdown while operating on battery power.
April 24, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Hazard: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
April 24, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Hazard: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
April 24, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Hazard: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
April 24, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
Hazard: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
April 24, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Hazard: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
April 24, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Hazard: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
April 24, 2024Medical DevicesFDA
Philips Respironics, Inc. recalls Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients. (sold outside US)
Hazard: Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
April 24, 2024Medical DevicesFDA
Outset Medical, Inc. recalls Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Hazard: Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been flushed out over time with usage. Exposure to PCBAs could cause: skin conditions, liver damage, impaired reproduction, development of certain kinds of cancer in humans.
April 24, 2024Medical DevicesFDA
Elekta Instrument AB recalls Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, 2.1mm Diameter / 14 Gauge, containing 6
Hazard: Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles. The sterility of the biopsy needles has not been affected. This issue has been reported from one site.
April 17, 2024Medical DevicesFDA
Intuitive Surgical, Inc. recalls Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098
Hazard: Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.
April 17, 2024Medical DevicesFDA
Boston Scientific Corporation recalls EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both ped
Hazard: Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
April 17, 2024Medical DevicesFDA
Boston Scientific Corporation recalls EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric
Hazard: Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
April 17, 2024Medical DevicesFDA
Boston Scientific Corporation recalls EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric an
Hazard: Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
April 17, 2024Medical DevicesFDA
Boston Scientific Corporation recalls EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pe
Hazard: Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
April 17, 2024Medical DevicesFDA
Boston Scientific Corporation recalls EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pedi
Hazard: Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
April 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASS
Hazard: Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
April 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE
Hazard: Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
April 17, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 34
Hazard: Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
April 17, 2024Medical DevicesFDA
Qiagen Sciences LLC recalls EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic an
Hazard: Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost