Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 2019
GE Healthcare
🏥 Medical Devices Class I - Dangerous
Backup batteries can fail earlier than their estimated life.
All Recalls
95,025 total recalls in our database
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
Wright Medical Technology
🏥 Medical Devices Class I - Dangerous
The instrument is incorrectly color coded.
🏥 Medical Devices Class I - Dangerous
The product is not able to provide irrigation.
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.
🏥 Medical Devices Class I - Dangerous
Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical operation into the patient body or in the operating field.
NaviCare Nurse Call/Voalte Nurse Call
Baxter Healthcare
🏥 Medical Devices Class I - Dangerous
An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software versions 3.9.100 through 3.9.300. Calls placed from a push button call device, such as a push button switch, call cord, or from the push buttons on a room audio station, will be canceled on the nurse call system when the call is answered at the wireless phone, regardless of the call priority.
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
🏥 Medical Devices Class I - Dangerous
Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.
🏥 Medical Devices Class I - Dangerous
A nonsterile component was packaged in a sterile convenience kit.
DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.
CHANGZHOU BIOMET MEDICAL DEVICES CO.
🏥 Medical Devices Class I - Dangerous
One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
🏥 Medical Devices Class I - Dangerous
The product is not able to provide irrigation.
🏥 Medical Devices Class I - Dangerous
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Product Name: GCX Channel Mounting Accessory Model/Catalog Number: H8-300-40-A
Skytron, Div. The KMW Group
🏥 Medical Devices Class I - Dangerous
Under certain circumstances, the mounting screws may loosen or pull out from the attachment point on the Ergon 3 boom when the GCX Channel Mounting Accessory was used with the VST clamp as a monitor mount on the boom.
🏥 Medical Devices Class I - Dangerous
Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammatory response; adverse local tissue reactions may occur related to cytotoxicity with the nonconforming rod and surrounding tissue.
🏥 Medical Devices Class I - Dangerous
Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay.
🏥 Medical Devices Class I - Dangerous
Packaging error.
Arrow Three-Lumen CVC
ARROW INTERNATIONAL
🏥 Medical Devices Class I - Dangerous
Gravity flow rates on the affected product lidstock are incorrect.
🏥 Medical Devices Class I - Dangerous
When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion may be displayed on TEG Manager for the affected assays.
🏥 Medical Devices Class I - Dangerous
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
🏥 Medical Devices Class I - Dangerous
Backup batteries can fail earlier than their estimated life.