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.
29,963 detailed records are currently available in this category.
measurements drawn on the 2nd and subsequent images of the series are not visible on printouts when the series is sent to print.
Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use.
Dimension Vista LOCI Thyroid Stimulating Hormone (TSH) Lot 14237AA may produce falsely depressed results ranging from -23% to -96% near the end of the well set due to inadequate reagent…
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste…
A potential safety issue due to loss of gas monitoring associated with occlusion of specific D-Fend / D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5…
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Software anomaly in the Panorama System software version 8.9 that manifests when the Panorama is in use with Mindray Passport V Monitor. Arrhythmia alarms which were previously displayed on…
Needle is leaking from hub/needle cannula connection
Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic…
The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste…
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
Terumo CVS is implementing field correction activities to address the identified causes of the Terumo System 1 experiencing loss of system power. These activities will be implemented in a…
The internal blue flapper valve of certain KimVent Turbo-Cleaning Closed Suction System for Adults may have a potential defect. If present, the defect potentially allows air to leak out of…
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
Terumo CVS is implementing field correction activities to address the identified causes of the Terumo System 1 experiencing loss of system power. These activities will be implemented in a…
The product does not bear the caution label regarding latex content. Potential for Allergic skin reaction
The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste…
Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow…
The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste…
The root cause investigation showed that the under-volume hazard can occur when the unit has been configured to prime with contrast, but instead primes with saline due to the configuration…
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
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.
