Medical Device Recalls

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8,689 medical device recalls from federal enforcement feeds.

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Showing 5,051–5,100 of 8,689

Medical Device Recall · November 25, 2024
Spacelabs Healthcare, Ltd.
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: R5
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: R5000688 Softw
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
Spacelabs Healthcare, Ltd.
Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram.
Due to a manufacturing error the incorrect device serial number was potentially programmed into the holter recorder. The physical serial number label on the device might not match the serial number programmed into the device.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S¿ Model Number: TB-0535FCS Catalog Number/Product Code: N
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
GE Medical Systems, LLC
GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3) 5555000-6; 4) A0659PB; 5) to be provided
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N542
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Telemetry receiver systems may experience a Windows proxy Issue causing the system to shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts; necessary clinical intervention could be delayed.
Class II
Medical Device Recall · November 25, 2024
GE Medical Systems, LLC
GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3) 5555000-33; 4) 5555000-41; 5) 5555000-47; 6) A0700DL; 7) A1700DA; 8)
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N54
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
Spacelabs Healthcare, Inc.
Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data.
Telemetry receivers with affected software versions may experience unsolicited system shut down and restart (Offline displayed), lasting approximately 1 to 1.5 minutes, which will cause temporary loss of monitoring. If a clinical event occurred during this period, staff may not detect until the system restarts and necessary clinical intervention could be delayed.
Class II
Medical Device Recall · November 25, 2024
Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N54
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II
Medical Device Recall · November 25, 2024
GE Medical Systems, LLC
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
Class II
Medical Device Recall · November 24, 2024
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;
Lack of 510(k) clearance.
Class II
Medical Device Recall · November 24, 2024
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;
Lack of 510(k) clearance.
Class II
Medical Device Recall · November 24, 2024
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;
Lack of 510(k) clearance.
Class II
Medical Device Recall · November 24, 2024
Adept Medical Ltd
Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
Lack of 510(k) clearance.
Class II
Medical Device Recall · November 24, 2024
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;
Lack of 510(k) clearance.
Class II
Medical Device Recall · November 24, 2024
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Lack of 510(k) clearance.
Class II
Medical Device Recall · November 24, 2024
Adept Medical Ltd
Otological Ventilation Tube - T-Tube 6mm - Double - Silicone; Product Code: NZ3306-2;
Lack of 510(k) clearance.
Class II
Medical Device Recall · November 24, 2024
Adept Medical Ltd
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Lack of 510(k) clearance.
Class II
Medical Device Recall · November 22, 2024
3M Company - Health Care Business
Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833 359-834 359-835 359-836 359-837
Attachments may not mate with the tooth as intended in the digital treatment design.
Class II
Medical Device Recall · November 22, 2024
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitati
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
Class II
Medical Device Recall · November 22, 2024
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
Class II
Medical Device Recall · November 22, 2024
Nipro Renal Soultions USA, Corporation
Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.
Class II
Medical Device Recall · November 22, 2024
Cook Biotech, Inc.
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Class II
Medical Device Recall · November 22, 2024
Cook Biotech, Inc.
Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Class II
Medical Device Recall · November 22, 2024
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
Class II
Medical Device Recall · November 22, 2024
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantita
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
Class II
Medical Device Recall · November 22, 2024
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
Class II
Medical Device Recall · November 22, 2024
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
Class II
Medical Device Recall · November 22, 2024
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
Class II
Medical Device Recall · November 22, 2024
Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative t
Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are met that can result in the incorrect patient name being assigned to a blood measurement by the device if the user of the device does not ensure verification of the correct patient name. The software malfunction has the potential to impact patient safety via misdiagnosis and/or mistreatment by a clinician if the wrong patient information is saved with the test result from the subject device.
Class II
Medical Device Recall · November 22, 2024
Cook Biotech, Inc.
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Class II
Medical Device Recall · November 21, 2024
GE OEC Medical Systems, Inc
OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagno
Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
Class II
Medical Device Recall · November 21, 2024
Abbott Medical
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed
Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing.
Class II
Medical Device Recall · November 21, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2) ENDOSCOPIC SINUS PACK, REF DYNJ40644A; 3) ENDO SINUS PACK, REF DYNJ66449.
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II
Medical Device Recall · November 21, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline custom medical procedure kits labeled as: 1) CERVICAL PACK-LF, REF DYNJ0867145G; 2) CERVICAL SPINE PACK HUM-LF, REF DYNJ35184F; 3) ANTERIOR CERVICAL-CORPECTOMY, REF DYNJ904827.
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II
Medical Device Recall · November 21, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II
Medical Device Recall · November 21, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYNJ901203C; 5) O
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II
Medical Device Recall · November 21, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline custom medical procedure kits labeled as: 1) MICRODISECTOMY PACK, REF DYNJ80585A; 2) MICRODISECTOMY PACK, REF DYNJ80585B.
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II
Medical Device Recall · November 21, 2024
Medtronic Neuromodulation
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B
Software issues were identified in application version 2.x.
Class II
Medical Device Recall · November 21, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRMING SURGERY, REF
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II
Medical Device Recall · November 21, 2024
MEDLINE INDUSTRIES, LP - Northfield
See DocMan
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II
Medical Device Recall · November 21, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline custom medical procedure kits labeled as: 1) UMC DR. BAKER SUPPLEMENT, REF DYNJ69476; 2) DIEP FLAP, REF DYNJ910120
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II
Medical Device Recall · November 21, 2024
MEDLINE INDUSTRIES, LP - Northfield
See DocMan
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II
Medical Device Recall · November 21, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR HOLE SHUNT PACK, REF DYNJ56819D; 4) BURR HOLE SHUN
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II
Medical Device Recall · November 21, 2024
MEDLINE INDUSTRIES, LP - Northfield
Medline custom medical procedure kits labeled as: DEEP BRAIN STIMULATION PACK-LF
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II
Medical Device Recall · November 21, 2024
Medtronic Neuromodulation
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, C
Software issues were identified in application version 2.x.
Class II