September 20, 2023Medical DevicesFDA
Abbott Medical recalls Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an ele
Hazard: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
September 20, 2023Medical DevicesFDA
Abbott Medical recalls Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an ele
Hazard: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
September 20, 2023Medical DevicesFDA
Abbott Medical recalls Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an e
Hazard: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
September 20, 2023Medical DevicesFDA
Abbott Medical recalls Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is a
Hazard: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
September 20, 2023Medical DevicesFDA
Abbott Medical recalls Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is a
Hazard: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
September 20, 2023Medical DevicesFDA
Abbott Medical recalls Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description:
Hazard: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
September 20, 2023Medical DevicesFDA
Abbott Medical recalls Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product
Hazard: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
September 20, 2023Medical DevicesFDA
Mallinckrodt Manufacturing LLC recalls Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
Hazard: The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
September 13, 2023Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls Reusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590
Hazard: The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
September 13, 2023Medical DevicesFDA
Aomori Olympus Co., Ltd. recalls Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope.
Hazard: The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
September 13, 2023Medical DevicesFDA
Diversatek Healthcare recalls ZVU Functional GI Software, REF: ZVU-3
Hazard: GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
September 13, 2023Medical DevicesFDA
Zimmer, Inc. recalls M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number
Hazard: The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
September 13, 2023Medical DevicesFDA
Aesculap Implant Systems LLC recalls For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Hazard: Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.
September 13, 2023Medical DevicesFDA
Philips Ultrasound, Inc. recalls 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU2
Hazard: Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in safety measures to prevent electric were to also fail.
September 13, 2023Medical DevicesFDA
PARAGON VISION SCIENCES, Inc recalls Fargo Ortho-K Lens
Hazard: Manufactured lenses are not covered by existing FDA approval
September 13, 2023Medical DevicesFDA
PARAGON VISION SCIENCES, Inc recalls ISee Ortho-K Lens
Hazard: Manufactured lenses are not covered by existing FDA approval
September 13, 2023Medical DevicesFDA
Cook Vandergrift, Inc. recalls Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. O
Hazard: Sterility of device may be compromised due to breach of the chevron seal of the packaging
September 13, 2023Medical DevicesFDA
Philips Medical Systems Nederland B.V. recalls MultiDiagnost-Eleva
Hazard: A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
September 13, 2023Medical DevicesFDA
Philips Medical Systems Nederland B.V. recalls Azurion
Hazard: A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
September 13, 2023Medical DevicesFDA
Philips Medical Systems Nederland B.V. recalls Allura Xper series
Hazard: A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
September 6, 2023Medical DevicesFDA
Reichert, Inc. recalls PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive erro
Hazard: Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthalmic stand. If the Phoroptor VRx Head detaches from the bracket, it can fall onto a patient or device operator
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-3C160.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-XT190.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-MP190F.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.