Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
22,462 detailed records are currently available in this category.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
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.
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
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,…
Reports of various packaging issues that may result in a breach of the sterile barrier.
Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order,…
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
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.
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP…
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.
Software defect concerning autosave mechanism may result in the clinician administering incorrect medication(s).
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…
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
