October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Hazard: Uncertainty in the seal integrity of the sterile packaging.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Hazard: Uncertainty in the seal integrity of the sterile packaging.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical portex, Y' PIECE 15MM, REF 100/276/000
Hazard: Uncertainty in the seal integrity of the sterile packaging.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/15
Hazard: Uncertainty in the seal integrity of the sterile packaging.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b)
Hazard: Uncertainty in the seal integrity of the sterile packaging.
October 30, 2024Medical DevicesFDA
Physio-Control, Inc. recalls STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibril
Hazard: Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles.
October 30, 2024Medical DevicesFDA
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION recalls Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the followin
Hazard: If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.
October 30, 2024Medical DevicesFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a co
Hazard: The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25¿C. This may lead to delay in patients' results.
October 30, 2024Medical DevicesFDA
Medtronic Neuromodulation recalls SynchroMed II Infusion Pump. Product Number: 8637-20
Hazard: Potential for error and inability to interrogate pump due to data corruption in the pump memory.
October 30, 2024Medical DevicesFDA
B-K Medical A/S recalls bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound sy
Hazard: The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable.
October 30, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and
Hazard: The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
October 30, 2024Medical DevicesFDA
Olympus Corporation of the Americas recalls Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and v
Hazard: The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
October 30, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Ster
Hazard: Product has been identified as having holes in the packaging.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Aisys CS2 with Et Control. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilat
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to p
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Aisys. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patie
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Avance CS2 and Avance CS2 Pro. These anesthesia gas machines are intended to provide general inhalation anesthesia and v
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Amingo. OUS only.
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to pati
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support t
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support t
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Aespire 100. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Datex-Ohmeda, Inc. recalls Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to
Hazard: Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
October 30, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3
Hazard: The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
Hazard: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
Hazard: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
Hazard: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
Hazard: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
Hazard: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.