The firm has become aware that there is a potential that the glass cover at the distal end of the camera/led lighting on the video laryngoscope could become loose during reprocessing or use. If this occurs during usage, it may result in a delay in procedure and/or require removal from body.
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not recognizing a patient is connected which could result in a delay in treatment
🏥 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
Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.
🏥 Medical Devices Class I - Dangerous
The OBM system functional test (impedance and noise) was not carried out on the affected items prior to release to the customer. The manufacturer cannot attest to the system functionality of the affected items.
🏥 Medical Devices Class I - Dangerous
During an FDA audit, it was discovered that the product was not properly registered with FDA.
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
The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the magnets failing to attract to one another. This may result in procedural delay in obtaining or creating a functional fistula and need for additional contrast to perform the necessary fluoroscopy. This can pose an incremental risk of harm to a diabetic patient's kidney function.
🏥 Medical Devices Class I - Dangerous
Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.
🏥 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.
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.
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.