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.
24,725 detailed records are currently available in this category.
Photometer Lamp May Reach Saturation Without Flagging Results, may generate erroneously elevated or depressed patient results
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
The IGS system can experience a single vertical line defect where the vertical line divides and horizontally shifts live monitor images into two unequal image parts within the monitor…
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, which may lead to increased…
The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line…
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
The product may have a yellowish-brown/greenish-brown residue present at the tip of the cannula.
Specific lots may have been manufactured with insufficient or incomplete welds.
Specific lots may have been manufactured with insufficient or incomplete welds.
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.
