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AnchorFast Guard Tube Fastener (Hollister) – Skin Barrier Wear Time (2024)
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
FDADec 23, 2024Nationwide• Hollister Incorporated
AnchorFast SlimFit Tube Fastener (Hollister) – Skin Barrier Wear Time (2024)
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
FDADec 23, 2024Nationwide• Hollister Incorporated
AnchorFast Guard Select Tube Fastener (Hollister) – Skin Barrier Wear Time (2024)

AnchorFast Oral Endotracheal Tube Fastener (Hollister) – Skin Barrier Wear Time (2024)
Hollister received reports of decreased skin barrier wear time which could can lead to tube migration
FDADec 23, 2024Nationwide• Hollister Incorporated

PERMA-HAND Silk Suture (Ethicon) – Packaging Seal Defect (2024)
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
FDADec 20, 2024Nationwide• Ethicon, LLC

ETHIBOND EXCEL Polyester Suture (Ethicon) – Packaging Seal Defect (2024)
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
FDADec 20, 2024Nationwide• Ethicon, LLC

Life2000 Ventilation System (Baxter) – Battery Charger Alarm (2024)
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
FDADec 20, 2024Nationwide• Baxter Healthcare Corporation

PROLENE Polypropylene Suture (Ethicon) – Packaging Seal Issue (2024)
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
FDADec 20, 2024Nationwide• Ethicon, LLC

Life 2000 Ventilation System (Baxter) – Battery Charger Alarm (2024)
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
FDADec 20, 2024Nationwide• Baxter Healthcare Corporation

GE Healthcare Varicam Millennium (GE Medical Systems) – Nuclear Medicine System Issue (2024)
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

GE Healthcare Discovery NM 630 (GE Medical Systems) – Nuclear Medicine System Issue (2024)
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

GE Healthcare Brivo NM 615 (GE Medical Systems) – Nuclear Medicine System Issue (2024)
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

GE Healthcare Infinia I (GE Medical Systems) – Nuclear Medicine System Issue (2024)
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

GE Healthcare Optima NM/CT 640 (GE Medical Systems) – Nuclear Medicine System Issue (2024)
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
FDADec 18, 2024Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

Panther Fusion GBS Assay (Hologic) – Pouch Seal Weakness (2024)
Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
FDADec 13, 2024AR, CA, CT +17 more• Hologic, Inc.

Temporary Titanium Abutments (DDS Lab) – Incorrect Implant Component (2024)
Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the affixed restoration; fragments could also injure oral mucosa, and could be aspirated.
FDADec 6, 2024Nationwide• DDS Lab

MISHA Knee System Implant (Moximed) – Component Fracture Risk (2024)
Knee implant may fracture due to a supplier-related issue with one component that has nonconforming geometry at the distal end of the absorber component that may result in a reduced wall thickness and microcracks, which may lead to new or worsening symptoms of discomfort, swelling / edema, pain or stiffness, which may necessitate removal of the device.
FDADec 2, 2024Nationwide• Moximed, Inc.

Merlin PCS Programmer (Abbott) – Software Anomaly (2024)
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.
FDANov 21, 2024Nationwide• Abbott Medical

StatStrip Glucose Ketone Meter (Nova Biomedical) – Result Error (2024)
A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in the process of transmitting the current test result to the DMS.
FDANov 20, 2024Nationwide• Nova Biomedical Corporation