Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.
Merits Holdings Co.
🏥 Medical Devices Class I - Dangerous
Pinion gear may disengage from track allowing lift to slip or jolt.
All Recalls
95,114 total recalls in our database
The firm has become aware of a potential problem that their Catheters may break/fracture and/or kink/bend if improperly removed from the packaging/dispenser hoop or during catheter use.
🏥 Medical Devices Class I - Dangerous
Distributed without an approved 510(k)
🏥 Medical Devices Class I - Dangerous
During an FDA audit, it was discovered that the product was not properly registered with FDA.
🏥 Medical Devices Class I - Dangerous
Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and displayed on the TEG Manager test result screen are rounded to the nearest whole number and lead to TEG Manager displaying an out of range alert when the test result is actually in range, or vice versa.
Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
Stryker Communications
🏥 Medical Devices Class I - Dangerous
The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may result in an insufficient mount force that causes the surgical light to fall. If the suspension of the surgical light falls, it may potentially cause serious injuries to Health Care Providers and/or patients.
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
🏥 Medical Devices Class I - Dangerous
At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer laser phototherapy system causes the device to fail to cease firing as long as the foot pedal or handpiece switch is depressed. This malfunction can cause overtreatment, which could result in strong erythema, and possibly cause blisters.
🏥 Medical Devices Class I - Dangerous
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
🏥 Medical Devices Class I - Dangerous
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
🏥 Medical Devices Class I - Dangerous
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
🏥 Medical Devices Class I - Dangerous
An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.
C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,
The Binding Site Group
🏥 Medical Devices Class I - Dangerous
A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
🏥 Medical Devices Class I - Dangerous
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
🏥 Medical Devices Class I - Dangerous
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
DeRoyal SECURITY CUFFS, Single Strap, QR Buckle Cuff and Bed, UNIVERSAL, REF M8138 - Product Usage: patient restraint.
DeRoyal Industries
🏥 Medical Devices Class I - Dangerous
One lot of product was inadvertently manufactured with a buckle which does not meet the mechanical hold force required for this device.
Lenox 2.5 Quart Tea Kettles
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The tea kettles can expel hot water during use, posing a burn hazard to consumers.
Blythe dressers
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The recalled dressers are unstable if not anchored to the wall, posing tip-over and entrapment hazards that may result in death or serious injuries to children. The dressers do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM 2057-17).
Musical Lili Llama
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The screws used to attach the spinning flowers to the sides of the toy can become loose and fall off, posing a choking hazard for young children.