Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2023-09-20FDA-DeviceAbbott MedicalClass IInfinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulati
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
- 2023-09-20FDA-DeviceAbbott MedicalClass IInfinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulati
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
- 2023-09-20FDA-DeviceAbbott MedicalClass IProclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimula
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
- 2023-09-20FDA-DeviceAbbott MedicalClass IProclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stim
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
- 2023-09-20FDA-DeviceAbbott MedicalClass IProclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stim
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
- 2023-09-20FDA-DeviceAbbott MedicalClass IProclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with mult
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
- 2023-09-20FDA-DeviceAbbott MedicalClass IProclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).
- 2023-09-20FDA-DeviceMallinckrodt Manufacturing LLCClass IMallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.
- 2023-09-13FDA-DeviceAomori Olympus Co., Ltd.Class IIReusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483, MH-587, MH-588(US), MH-589, MH-590, MH-591, MH-592, MH-593, MH-594, MH-595, MH-596, MH-597, MH-598, MAJ-289, MAJ-290, MAJ-291, MAJ-292, MAJ-293, MAJ-294, MAJ-295, MAJ-296, MAJ-297, MAJ-663, MAJ-664, MAJ-665, MAJ-666
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
- 2023-09-13FDA-DeviceAomori Olympus Co., Ltd.Class IIOlympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012
The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
- 2023-09-13FDA-DeviceDiversatek HealthcareClass IIIZVU Functional GI Software, REF: ZVU-3
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
- 2023-09-13FDA-DeviceZimmer, Inc.Class IIM/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
- 2023-09-13FDA-DeviceAesculap Implant Systems LLCClass IIFor intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
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.
- 2023-09-13FDA-DevicePhilips Ultrasound, Inc.Class II3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
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.
- 2023-09-13FDA-DevicePARAGON VISION SCIENCES, IncClass IIFargo Ortho-K Lens
Manufactured lenses are not covered by existing FDA approval
- 2023-09-13FDA-DevicePARAGON VISION SCIENCES, IncClass IIISee Ortho-K Lens
Manufactured lenses are not covered by existing FDA approval
- 2023-09-13FDA-DeviceCook Vandergrift, Inc.Class IICook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
Sterility of device may be compromised due to breach of the chevron seal of the packaging
- 2023-09-13FDA-DevicePhilips Medical Systems Nederland B.V.Class IIMultiDiagnost-Eleva
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
- 2023-09-13FDA-DevicePhilips Medical Systems Nederland B.V.Class IIAzurion
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
- 2023-09-13FDA-DevicePhilips Medical Systems Nederland B.V.Class IIAllura Xper series
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
- 2023-09-06FDA-DeviceReichert, Inc.Class IIPHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye. MODEL NUMBER: 16242 [Model 16241 is the base model. Model 16242 includes an additional prism feature used for the measurement of ocular deviation in patients with latent or manifest strabismus].
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
- 2023-09-06FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP.
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- 2023-09-06FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus Bronchovideoscope, Models BF-3C160.
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- 2023-09-06FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus Bronchovideoscope, Models BF-3C40 & BF-N20.
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- 2023-09-06FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- 2023-09-06FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus Bronchovideoscope, Models BF-P190 & BF-XP190.
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- 2023-09-06FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- 2023-09-06FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus Bronchovideoscope, Models BF-XT190.
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- 2023-09-06FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus Bronchovideoscope, Models BF-MP190F.
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
- 2023-09-06FDA-DeviceOlympus Corporation of the AmericasClass IIOlympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190.
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
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