🏥 Medical Devices Class I - Dangerous
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
The Autostainer instrument may not have a syringe tray installed which could result in a small volume of excess buffer being applied to several slides. In addition to the syringe tray, the updated Basic User Guide will reduce the potential risk of false negative results in the case of leakage of buffer and/or reagents that may impact staining.
🏥 Medical Devices Class I - Dangerous
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
🏥 Medical Devices Class I - Dangerous
Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a fiducial-less procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging).
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, Sterile, Catalog # 504-02-66F-L, UDI (01)07613327012491(17)
Howmedica Osteonics
🏥 Medical Devices Class I - Dangerous
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 68 right, Sterile, Catalog # 504-02-68F-R, UDI (01)07613327012514(17)
Howmedica Osteonics
🏥 Medical Devices Class I - Dangerous
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
🏥 Medical Devices Class I - Dangerous
Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five (5) years.The affected product will begin expiring in March 2020. Using product beyond the validated shelf-life may result in (1) product not functioning as intended and/or (2) a delay in procedure or the need for the procedure to be rescheduled.
🏥 Medical Devices Class I - Dangerous
hearing performance degradation due to body-fluid entering the device.
🏥 Medical Devices Class I - Dangerous
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
🏥 Medical Devices Class I - Dangerous
Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.
Medline identified that there may be a potential for voids in the packaging seal and loss of sterility on the outside of the foil pouch.
BARD MYPICC KIT 3F Single-Lumen, Catalog Number CK000417B
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
The kits contain surgical gowns which were subject to a recall by the supplier.
🏥 Medical Devices Class I - Dangerous
A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone.
🏥 Medical Devices Class I - Dangerous
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
🏥 Medical Devices Class I - Dangerous
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
🏥 Medical Devices Class I - Dangerous
The firm has become aware through their optical laboratory supplier that prescription spectacle lenses within various frames failed to meet safety specification for shatter resistance. This could result in cracked or broken lenses.
🏥 Medical Devices Class I - Dangerous
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Wide Fit Kitten Heel Court Pumps
Unknown Manufacturer
🏠 Consumer Products Class II - Moderate
The leather insock in the shoes has elevated levels of Chromium VI, posing a risk of skin irritation.
Sanvall Rapid Alivio Pain Relieving Roll-On
Sanvall Enterprises Inc., of Doral, Fla.
🏠 Consumer Products Class II - Moderate
The product contains the substance methyl salicylate which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the product is not child resistant, posing a risk of poisoning if the contents are swallowed by young children.
Nelson and Lauki Dressers and Cabinets
Unknown Manufacturer
🏠 Consumer Products Class I - Dangerous
The recalled dressers and cabinets are unstable and can tip over if not anchored to the wall, posing serious tip-over and entrapment hazards that can result in death or injuries to children. The chests do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM F2057-19).