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.
26,155 detailed records are currently available in this category.
Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.
Manufacturing flaw in the sterile barrier system
Manufacturing flaw in the sterile barrier system
Manufacturing flaw in the sterile barrier system
The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and…
Manufacturing flaw in the sterile barrier system
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical…
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical…
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Manufacturing flaw in the sterile barrier system
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode.
Manufacturing flaw in the sterile barrier system
Manufacturing flaw in the sterile barrier system
There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode.
Manufacturing flaw in the sterile barrier system
This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to an issue with the consistency of the inner lumen thickness of the silicone tubing segment…
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
The firm received a complaint that the connector detached from the feeding tube.
The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum levels to elute into the infusate. The Use of the BD Alaris Pump Infusion Set may lead to…
The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and…
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed…
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.
