Medical device recalls
38685 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2023-06-28FDA-DeviceKarl Storz EndoscopyClass IIMetal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, REF: 11580C; Metal Tray, 275 x 175 x 37 mm, REF: 11580D; Wire Tray f. Cleaning, 290x60x52mm, REF: 39501A1; Wire Tray f. Cleaning, 352 x 125 x 54 mm, REF: 39501A2; Wire Tray f. Cleaning, 487 x 125 x 54 mm, REF: 39501B2; Wire Tray for ENDOCAMELEON, REF: 39501BEC; Tray, with lid, 670x80x52mm, REF: 39501C; Wire Tray for ENDOCAMELEON, long version, REF: 39501CEC; Wire Tray
Metal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.
- 2023-06-28FDA-DeviceOlympus Corporation of the AmericasClass IISingle Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
- 2023-06-28FDA-DeviceOlympus Corporation of the AmericasClass IISingle Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
- 2023-06-28FDA-DeviceOlympus Corporation of the AmericasClass IISingle Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.B
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
- 2023-06-28FDA-DeviceOlympus Corporation of the AmericasClass IISingle Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially causing harms to patients. The complaints include reports that: 1) the clip arm does not open when the user pushes the slider, 2) the clip arm does not close when the user pulls the slider and 3) the clip detaches from the target tissue earlier than expected, after being deployed in a procedure.
- 2023-06-28FDA-DeviceMasimo CorporationClass IIMasimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
TC-I tip clip sensor may produce readings outside the accuracy specification.
- 2023-06-28FDA-DeviceMasimo CorporationClass IIMasimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
TC-I tip clip sensor may produce readings outside the accuracy specification.
- 2023-06-28FDA-DeviceMasimo CorporationClass IIMasimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
TC-I tip clip sensor may produce readings outside the accuracy specification.
- 2023-06-28FDA-DeviceMasimo CorporationClass IIMasimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
TC-I tip clip sensor may produce readings outside the accuracy specification.
- 2023-06-28FDA-DeviceMEDLINE INDUSTRIES, LP - NorthfieldClass IIMEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Medline issued a recall on TheraHoney Wound Gel due to the manufacturer notifying Medline of a sterilization dose audit failure on the wound gel and not augmenting the dose after failure per ISO 11137.
- 2023-06-28FDA-DeviceKarl Storz EndoscopyClass IIKARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality.
- 2023-06-28FDA-DeviceSenTec AGClass IIV-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.
- 2023-06-28FDA-DeviceWilson-Cook Medical Inc.Class IIHemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.
- 2023-06-28FDA-DeviceWilson-Cook Medical Inc.Class IIHemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.
- 2023-06-28FDA-DeviceIllumina, Inc.Class IIMiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Cybersecurity vulnerability concerning the software used for sequencing instruments.
- 2023-06-28FDA-DeviceIllumina, Inc.Class IINextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Cybersecurity vulnerability concerning the software used for sequencing instruments.
- 2023-06-28FDA-DeviceHelena Laboratories, Corp.Class IISerrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result.
- 2023-06-28FDA-DeviceARROW INTERNATIONAL Inc.Class IARROW Endurance Extended Dwell Peripheral Catheter System
Potential for catheter separation or leakage
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD CROME VR MRI DF4, Model Number DVPC3D4; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- 2023-06-28FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
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