Complete FDA and NHTSA recall records dated in January 2025.
These records include useful source details for the selected month.
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
Reports of various packaging issues that may result in a breach of the sterile barrier.
Reports of various packaging issues that may result in a breach of the sterile barrier.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of…
Reports of various packaging issues that may result in a breach of the sterile barrier.
Incorrect expiration date listed on the outer box, which does not align with the correct expiration date listed on the inner tray.
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
Reports of various packaging issues that may result in a breach of the sterile barrier.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Reports of various packaging issues that may result in a breach of the sterile barrier.
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…
Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy,…
There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal,…
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…
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
