95,114 total recalls in our database
Brochures and web site information for the HyperBlue 1530 diode laser promoted features which had not been cleared in the product's premarket notification to the FDA. The web site and brochures had claims that it could use 940 nm, 808 nm, and 532 nm wavelengths as single wavelengths or in combination with other wavelengths, and a claim that the product could be used with a 15 mm hand piece.
AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).
The blood pressure (BP) circuit occasionally fails to inflate the blood pressure cuff and the BP circuit fails to activate, resulting in no BP measured.
The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.
Units may be labeled with the incorrect diopter power.
In specific situation a partially truncated file may be written to the IntelePACS server. This partially truncated file still can be viewed by InteleViewer and InteleViewer will report to the user that the file in question is complete. This situation only occurs if a file is partially truncated.
Omnilife Science
Staining on hip implant.
Synthes
DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they may reverse post-operatively.
Units may be labeled with the incorrect diopter power.
A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic.
ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.
Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.
Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
Philips Medical Systems
Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress ECG system have the potential for the patient record to contain multiple and therefore inaccurate patient identifiers such as: patient name, patient ID (PID), Medical record number (MRN). This creates the potential for misdiagnosis and incorrect therapy.
Units may be labeled with the incorrect diopter power.
Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I, CTNI (RF421C), LTNI (RF521C); Free T4, FT4 (RF410); Thyroid Stimulating Hormone, TSH (RF412); and N-terminal pro-brain natriuretic peptide, PBNP (RF423A) and LPBN (RF523A) when using Dimension® Chemistry Wash lot RD41041. Internal inv
Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.
The wireless function of the IP5 radio could be interrupted causing loss of wireless communication between the IP5 and host monitoring system.
The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fungi, which are commonly found molds.
Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.