🏥 Medical Devices Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
All Recalls
95,018 total recalls in our database
Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer.- SMN: 11206236
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
🏥 Medical Devices Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.
🏥 Medical Devices Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Product does not meet the Instructions for Use (IFU) claimed Pack Calibration Interval of 10 days. IFU calibration updated interval from 10 days to 3 days for all current and future kit lot numbers
A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano.
LiquaSonic Ultrasound Gel 5L, Model No. 001222
Athena Medical Products
🏥 Medical Devices Class I - Dangerous
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
🏥 Medical Devices Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
Pipeline Flex Embolization Device
Micro Therapeutics Inc,
🏥 Medical Devices Class I - Dangerous
Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
🏥 Medical Devices Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
🏥 Medical Devices Class I - Dangerous
When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
🏥 Medical Devices Class I - Dangerous
Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
🏥 Medical Devices Class I - Dangerous
Specific serial numbers of the Solero MTA Generator require servicing to upgrade the software to help reduce the incidence of Error 0001, which can occur during system start-up.
Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator
Philips North America
🏥 Medical Devices Class I - Dangerous
Infant/Child defibrillator pads contain incorrect labeling. This could lead to a delay in therapy, or delivery of lower energy than indicated for an adult patient
Gas One propane adapter hoses
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The hose can swell during use causing gas to leak, posing a fire hazard.
Ballz QR Skewers
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The skewer, which connects the Coho XC Cargo Trailer to the bicycle, can shear or bend. This can cause instability of the trailer and the towing bicycle and pose a fall hazard for the bicycle rider.
Janod Children's Shaving Kits
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The brown trim of the shaving kit bags contains levels of a regulated phthalate that exceed the prohibition of specific phthalates. Banned phthalates are toxic if ingested by young children and can cause adverse health issues.
Teak shower benches
Ivena International Pte. Ltd., of Singapore
🏠 Consumer Products Class II - Moderate
The shower bench can collapse during use, posing a fall hazard to the user.
VITUS 14 and VITUS 16 Kids Bikes
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The bicycles have handbrakes but no footbrakes. Federal regulations require the bicycles be equipped with both handbrakes and footbrakes. Sidewalk bicycles with handbrakes, but no footbrakes, may present a risk of injury to young children who might not be able to stop the bicycles using handbrakes only.