92,900 total recalls in our database
Apic Yamada America
Apic Yamada has recently discovered that certain products may be out of compliance with FDA electronic product regulations in that they did not bear a required label.
LTS Therapy Systems
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
Maquet Cardiopulmonary Gmbh
Device does not comply with the labeling requirements of international standard IEC 60601-1.
Philips North America
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
LTS Therapy Systems
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
Fresenius Kabi USA
Potential for external cassette leaks
MEDLINE INDUSTRIES, LP - Northfield
SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.
Fresenius Kabi USA
Potential for external cassette leaks
The products may contain surface and subsurface contamination of Listeria monocytogenes.
Philips North America
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Remote Diagnostic Technologies
Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.
Capnia
Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to sealing, which may lead to higher than expected ETOCc scores during clinical evaluations.
MICROVENTION
Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than target vessel, increased procedure time, incomplete embolization, and/or inability to treat the patient.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
3Z Brands, of Glendale, Arizona
The recalled mattresses violate a mandatory flammability standard for mattresses, posing a fire hazard and risk of serious injury or death to consumers.
Unknown Manufacturer
The recalled children's loungewear violates the flammability standards for children's sleepwear, posing a risk of burn injuries and death to children.
KidKraft Inc., of Dallas, Texas
If young children are climbing on the counter or crawling through the opening at the back of the play kitchen, their clothing can get caught on the plastic or metal hooks meant to hold toy kitchen accessories such as play pots and pans, posing a strangulation hazard.
Unknown Manufacturer
The safety bar can detach or break while in use, posing serious fall and injury hazards to consumers.
Unknown Manufacturer
Small metal pieces can detach from the garlic press, posing a laceration or ingestion hazard to consumers.