Class I - Dangerous
Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Class I - Dangerous
Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Horiba Instruments, Inc
Class I - Dangerous
Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software
There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.
Class I - Dangerous
Liko/Hill-Rom has received reports from facilities which indicate that serious injuries have been received related to the Standard Sling bar 450. There have been 6 complaints of injury related to the product over the past 32 years (6 out of 838,687,856 estimated patient uses). One of the injuries was associated with a patient during use, four injuries occurred when the slingbar was not in use wher
AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
Cooper Vision Caribbean
Class I - Dangerous
The lenses exceeded the acceptance limit for silicone oil residual.
Class I - Dangerous
Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact.
Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.
sanofi-aventis US
Class I - Dangerous
Diamigo, a software application, was released through the i-Phone Global Store which inadvertently allowed global access to the application as opposed to the original intended restriction of access to Brazil.
Class I - Dangerous
Additional Warning Statement to prevent burns to the skin
Class I - Dangerous
Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. If the PEEK Ardis Interbody Spacer breaks during implantation, surgical delays of up to 60 minutes could occur. Sharp edges of the broken implant may contact and damage adjacent structures, requiring surgical intervention. Observed health risks
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Radiometer America
Class I - Dangerous
The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that the control range is 7.40-7.45.
Class I - Dangerous
Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to software version 4.5.5. The update will provide a number of improvements to address nonhazardous reliability issues which will improve the overall quality and functionality of the EBW.
Class I - Dangerous
The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.
Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit .
Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
Varian Medical Systems, Inc. Oncology Systems
Class I - Dangerous
Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiation Oncology [ARIA RO] DICOM import/export functionality where a 360 degree arc field may convert to static field during DICOM export or import.
Class I - Dangerous
The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in its own packaging. The product was not labeled or identified as sterile, but was assumed to be sterile by the customer.
Class I - Dangerous
Posterior fluidics modules installed in the system may need to be recalibrated.
ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically transport one mobility impaired person in a fold-down seat up and down straight stairs, indoors and outdoors.
ThyssenKrupp Access
Class I - Dangerous
The seat could break as a result of damage resulting from a seat belt being trapped underneath the foldable part of the seat when the seat belt is not buckled.
Class I - Dangerous
An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm's Mayfield Composite Series Base Units and Mayfield Skull Clamps. In order to prevent additional complaint reports, the firm decided to recall and replace certain lot codes of the Base Units and Skull Clamps that were d
Class I - Dangerous
EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices.