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.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
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…
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.
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…
Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per…
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.
Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used…
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.
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This…
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…
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.
Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below…
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.…
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.…
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.
