All Recalls

95,114 total recalls in our database

McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes, and to identify in a timely manner whether a parameter box is out of calibration. McKesson has identified that its communication to customers regarding the required maintenance tests was insufficient. While each unit has an attached sticker i

Jun 25, 2014 Diagnostic Equipment Nationwide View Details β†’

Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped

Oct 3, 2014 Diagnostic Equipment Nationwide View Details β†’

Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.

Oct 7, 2014 Implants & Prosthetics Nationwide View Details β†’

Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.

Sep 15, 2014 Diagnostic Equipment Nationwide View Details β†’

Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.

Sep 2, 2014 Infusion Pumps Nationwide View Details β†’

Mindray DS USA Inc. initiated a voluntary field corrective action for V-Series Patient Monitor because there is an issue with the V-Series Drug Calculator function.

Jul 31, 2014 Diagnostic Equipment Nationwide View Details β†’

Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)

Sep 19, 2014 Implants & Prosthetics View Details β†’

St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio" Hemostasis Introducer, Catalog number 406308. The inner diameter of the 10F dilator is too small, such that the guidewire cannot advance through the device which may result in a procedural delay while another dilator of the desired size is obtained.

Oct 14, 2014 Other Medical Devices Nationwide View Details β†’

Martara Instrument, Inc. has recently became aware of a potential safety hazard involving our Surveyor rand S12 S19 Patient Monitors. A hazardous situation may be created when mounting these monitors using the 75mm VESA mounting hole pattern provided in the battery cover of these monitors. If the mounting screws provided by Mortara are not used and if the mounting screws used are longer than the p

Oct 7, 2014 Diagnostic Equipment Nationwide View Details β†’

Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its capacity during a 60 minute charging period. If you have a fully discharged Ultra Battery 1 (TA-UB1), in order to achieve a 100% of charge capacity you should charge it for a period of 90 minutes. In addition, the charging voltage range of 10-36V specified on the Ultra Battery 1 (TA-UB1) label and in t

Jul 25, 2014 Infusion Pumps Nationwide View Details β†’

tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)

Sep 15, 2014 Surgical Instruments Nationwide View Details β†’

Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.

Sep 15, 2014 Diagnostic Equipment Nationwide View Details β†’

Customer complaints were received for positive bias reported on the controls used on the IMMULITE /IMMULITE 1000 on the Cortisol Assay reagent lots IMMULITE /IMMULITE 1000 (LKCO1) Lots 381,382 and 383 . Subsequently, the firm confirmed a positive bias on the IMMULITE/IMMULITE 1000 (LKCO1) Lots 381, 382 and 383.

Sep 19, 2014 Diagnostic Equipment Nationwide View Details β†’