291 results

• Duodenoscope Recall Issued by Fujifilm For Older Models Linked To Infection Risk

  January 16, 2017

  Irvin Jackson

  Fujifilm is recalling some older model duodenoscopes to replace them with those which have updated cleaning instructions for avoiding hospital-acquired infections.

• Nurse Assist Flush Syringe Recall Classified Class I By FDA Over Infection Risks

  January 5, 2017

  Martha Garcia

  The FDA is warning that a Nurse Assist Inc. saline flush syringe recall has been given a Class I designation, following reports of infections among patients.

• Top 10 Recalls from 2016

  December 27, 2016

  Irvin Jackson

  The top ten recalls of 2016 had a wide range of impact, from cell phones to flour to hip implants.

• Hip Replacement Surgical Device Recalled Due Amid Sterilization Concerns

  December 19, 2016

  Irvin Jackson

  A recall of about 3,000 devices used during hip replacement surgery has been issued over concerns that they are not sterile even after following the manufacturer's sterilization instructions, which could lead to serious and even fatal infections.

• FDA Issues New Guidance On When To Warn Public About Medical Device Problems

  December 14, 2016

  Irvin Jackson

  The FDA has issued new guidance determining when the public should be warned about adverse events linked to medical devices already on the market.

• Bacterial Infection Outbreak at Nursing Homes and Hospitals Linked To Contaminated Syringes

  November 17, 2016

  Russell Maas

  An infection outbreak linked to recalled syringes has sickened more than 150 patients in hospitals and nursing homes across five states.

• Recalled HeartWare Heart Implants Pose Risk of Serious Injury, Death, FDA Warns

  November 17, 2016

  Irvin Jackson

  Two recent HeartWare Ventricular Assist Device recalls have been given Class I designations by the FDA, meaning they carry a serious risk of severe injury or death.

• Heartware Ventricular Assist Device Recall Issued Due to Loose Connector Risk

  October 31, 2016

  Irvin Jackson

  Another HVAD recall has been announced, this time involving heart pump controllers that may have loose connections.

• St. Jude Recalls Fortify, Unify, Assura ICDs and CRT-Ds Due to Rapid Battery Failure Risk

  October 26, 2016

  Irvin Jackson

  A warning over battery failures in some St. Jude ICD and CRT-D heart implants has been upgraded to a class I recall, the FDA's most serious recall classification.

• Heartware Ventricular Assist Device Recall: Electrical Problems That Could Cause Death

  October 24, 2016

  Martha Garcia

  A risk of malfunctions that could cause serious injury or death has led to the recall of some Heartware Ventricular Assist Device heart pumps.