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.
21,924 detailed records are currently available in this category.
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Potential for the presence of visible foreign matter.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to…
The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
Potential for microbial contamination.
Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia,…
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to…
An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of…
Potential for exoskeleton to lose lateral balance and cause patient to fall.
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to…
Due to a potential open seal in the sterile barrier packaging.
Inadequate weld that can potentially cause the product to disassemble.
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Due to a potential open seal in the sterile barrier packaging .
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the…
Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury…
The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear,…
Due to a potential open seal in the sterile barrier packaging .
A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista…
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.
