O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Emergency Products & Research
🏥 Medical Devices Class I - Dangerous
Failure of adhesive to secure the pole insert.
All Recalls
95,114 total recalls in our database
VITROS Performance Verifier II
Ortho-Clinical Diagnostics
🏥 Medical Devices Class I - Dangerous
The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.
stay-safe /Luer Lock Catheter Ext. 12 in
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.
HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
Puritan Medical Products Company
🏥 Medical Devices Class I - Dangerous
It was discovered through a customer complaint that mislabeled product was distributed. Puritan distributed product labelled as 25-3317-H lot S1014 which contained product code 25-3317-U in all packages.
stay-safe /Safe Lock Catheter Ext. 12 in
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
The peroxide cross-linked tubing has leachables identified as NDL PCBAs.
MediBeads Neck Wrap, Item Number 34320
Bruder Healthcare Company
🏥 Medical Devices Class I - Dangerous
Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
Thermalon Eye Compress, Item Number 2434
Bruder Healthcare Company
🏥 Medical Devices Class I - Dangerous
Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R
Bruder Healthcare Company
🏥 Medical Devices Class I - Dangerous
Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
Thermalon Heating Pad, Item Number 24002
Bruder Healthcare Company
🏥 Medical Devices Class I - Dangerous
Thermalon and MediBeads moist heat compresses from certain lots may have been exposed to excessive moisture, resulting in potential growth of mold and/or mildew.
🏥 Medical Devices Class I - Dangerous
InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing. The device will not be available or supported after June 20, 2024.
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Boston Scientific
🏥 Medical Devices Class I - Dangerous
Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilator or ablation catheter).
🏥 Medical Devices Class I - Dangerous
InfuTronix is removing the Nimbus Infusion Pump Systems from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing. The device will not be available or supported after June 20, 2024.
🏥 Medical Devices Class I - Dangerous
Use of assay along with plasma specimen may result in error code which would invalidate sample.
Berkley Jensen Citronella 72-inch Tiki Torches
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The tiki torch top can break open and/or fall off while lit, posing a burn hazard.
Forias Pack and Play Mattresses
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The recalled mattress violates multiple provisions of the Safety Standard for Crib Mattresses, including the thickness test, and is missing the required warnings and labels. The product poses a suffocation hazard to infants.
Model Year 2022-2023 Snowmobiles equipped with PATRIOT BOOST Engines
Polaris Industries Inc., of Medina, Minnesota
🏠 Consumer Products Class I - Dangerous
The fuel line between the fuel rails can leak, posing a fire hazard.
Purefog High Density Natural Fog Juice Liquids
Pure Brands of California, of San Diego, California
🏠 Consumer Products Class II - Moderate
The recalled fog liquid can expire sooner than the expiration date listed on the product. This can pose a risk of respiratory or other infections in individuals with compromised immune systems, damaged lungs or an allergy to mold.
Magnetic Beads HIGH POWER 5mm
Boss Magnet, of Taiwan
🏠 Consumer Products Class I - Dangerous
The magnetic beads violate the requirements of the mandatory federal magnet regulation because they contain one or more magnets that fit within CPSC's small parts cylinder, and the magnets are stronger than permitted. When high-powered magnets are swallowed, the ingested magnets can attract each other or another metal object and become lodged in the digestive system. This can result in perforations, twisting and/or blockage of the intestines, infection, blood poisoning and death.
🍎 Food Class I - Dangerous
Listeria monocytogenes. The recalled Cotija cheese was repackaged into finished wholesale and retail RTE products.