US Recall News » Urgent Recalls

FDA Classifies Riata and Riata ST Silicone Defibrillation Leads as Class I Recall

FDA — Fri, 16 Dec 2011 00:00:00 +0000

The FDA has classified this recall as a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction.

Finish Reading: FDA Classifies Riata and Riata ST Silicone Defibrillation Leads as Class I Recall

Abbott Diabetes Care Recalls Certain Lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips

FDA — Fri, 24 Dec 2010 00:00:00 +0000

Abbott Diabetes Care has initiated a recall of 359 lots (approximately 359 million strips) of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips in the United States and Puerto Rico.

Finish Reading: Abbott Diabetes Care Recalls Certain Lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips

Bassettbaby Recalls to Repair Drop-Side Cribs Due to Entrapment, Suffocation and Fall Hazards

CPSC — Tue, 23 Nov 2010 00:00:00 +0000

THE RECALLED CRIBS ARE WOOD WITH A METAL MATTRESS SUPPORT AND HAVE A DROP SIDE WITH EXTERNAL PLASTIC HARDWARE. THE CRIBS WERE SOLD IN A VARIETY OF FINISHES. A LABEL IS ATTACHED TO THE FOOTBOARD OR HEADBOARD WITH THE NAMES BASSETTBABY OR BASSETT FURNITURE INDUSTRIES, INC.

Finish Reading: Bassettbaby Recalls to Repair Drop-Side Cribs Due to Entrapment, Suffocation and Fall Hazards

Darvocet Recall – Potentially Fatal Heart Abnormalities Final Straw

E. Sizemore — Sat, 20 Nov 2010 01:55:13 +0000

Xanodyne Pharmaceuticals, Inc. is cooperating with the FDA in recalling Darvocet and Darvon, their versions of the pain killer propoxyphene. Darvocet could cause serious and potentially fatal heart rhythm abnormalities, says the FDA.

Finish Reading: Darvocet Recall – Potentially Fatal Heart Abnormalities Final Straw

Deaths Prompt CPSC, FDA Warning on Infant Sleep Positioners

CPSC — Mon, 20 Sep 2010 00:00:00 +0000

12 REPORTS OF INFANTS BETWEEN THE AGES OF 1 MONTH AND 4 FOUR MONTHS WHO DIED WHEN THEY SUFFOCATED IN SLEEP POSITIONERS OR BECAME TRAPPED AND SUFFOCATED BETWEEN A SLEEP POSITIONER AND THE SIDE OF A CRIB OR BASSINET.

Finish Reading: Deaths Prompt CPSC, FDA Warning on Infant Sleep Positioners

Integra Issues Urgent Worldwide Recall of NeuroBalloonTM Catheter

FDA — Wed, 25 Aug 2010 00:00:00 +0000

Integra LifeSciences Corporation, Plainsboro, New Jersey, has initiated a worldwide recall of the NeuroBalloon Catheter.

Finish Reading: Integra Issues Urgent Worldwide Recall of NeuroBalloonTM Catheter

Child’s Death Prompts Recall to Repair Portable Playard Tent by Tots in Mind

CPSC — Fri, 16 Jul 2010 00:00:00 +0000

THE BOY WAS FOUND HANGING WITH HIS NECK ENTRAPPED BETWEEN THE PLAYARD FRAME AND THE METAL BASE ROD OF THE TENT THAT HAD BEEN PARTIALLY TIED BY PIECES OF NYLON ROPE AND PARTIALLY ATTACHED BY CLIPS. THE TENT WAS TIED TO THE PLAYARD BECAUSE THE CHILD WAS ABLE TO POP OFF THE CLIPS.

Finish Reading: Child’s Death Prompts Recall to Repair Portable Playard Tent by Tots in Mind

Aqua Lung America Recalls Apeks WTX Power Inflators Due to Drowning Hazard

CPSC — Thu, 01 Jul 2010 00:00:00 +0000

THE ORAL INFLATOR BUTTON IS NOT PROPERLY BONDED TO THE ORAL STEM AND CAN FALL OFF DURING USE, POSING A LEAK OF THE BUOYANCY COMPENSATOR CONTENTS. THIS POSES A DROWNING HAZARD.

Finish Reading: Aqua Lung America Recalls Apeks WTX Power Inflators Due to Drowning Hazard

Infant Death Prompts Recall of Ring Slings Made by Sprout Stuff Due to Suffocation Risk

CPSC — Thu, 03 Jun 2010 00:00:00 +0000

CONSUMERS SHOULD IMMEDIATELY STOP USING THE RECALLED SLINGS AND CONTACT SPROUT STUFF TO RETURN THE SLING FOR A FULL REFUND.

Finish Reading: Infant Death Prompts Recall of Ring Slings Made by Sprout Stuff Due to Suffocation Risk

Target Recalls Storage Trunks Due to Strangulation Hazard

CPSC — Fri, 21 May 2010 00:00:00 +0000

CPSC HAS RECEIVED TWO REPORTS OF INJURIES THAT OCCURRED WHEN THE STORAGE TRUNKS’ LIDS SUDDENLY CLOSED ON CHILDREN, INCLUDING ONE REPORT OF AN 18-MONTH-OLD GIRL WHO REPORTEDLY SUFFERED BRAIN DAMAGE WHEN THE TRUNK’S LID CAME DOWN ON THE BACK OF HER NECK AND PINNED HER THROAT AGAINST THE RIM OF THE TRUNK.

Finish Reading: Target Recalls Storage Trunks Due to Strangulation Hazard

CPSC Issues Warning on Drop-Side Cribs

CPSC — Sat, 08 May 2010 00:00:00 +0000

AS PART OF ITS COMMITMENT TO ENSURE SAFE SLEEP FOR YOUNG CHILDREN, THE U.S. CONSUMER PRODUCT SAFETY COMMISSION (CPSC) IS ONCE AGAIN WARNING PARENTS AND CAREGIVERS ABOUT DEADLY HAZARDS WITH DROP-SIDE CRIBS.

Finish Reading: CPSC Issues Warning on Drop-Side Cribs

CPSC Announces Recalls to Repair Millions of Roman Shades and Roll Up Blinds by Multiple Firms

CPSC — Thu, 17 Dec 2009 00:00:00 +0000

STRANGULATIONS IN ROMAN SHADES OCCUR WHEN A CHILD PLACES HIS/HER NECK BETWEEN THE EXPOSED INNER CORD AND THE FABRIC ON THE BACK SIDE OF THE BLIND OR WHEN A CHILD PULLS THE CORD OUT AND WRAPS IT AROUND HIS/HER NECK.

Finish Reading: CPSC Announces Recalls to Repair Millions of Roman Shades and Roll Up Blinds by Multiple Firms

Synthes USA, Ti Synex II Vertebral Body Replacement

FDA — Fri, 13 Nov 2009 00:00:00 +0000

This device is a vertebral body replacement device that is used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body due to a tumor or trauma.

Finish Reading: Synthes USA, Ti Synex II Vertebral Body Replacement

Edwards Lifesciences CardioVations EndoClamp Aortic Catheter

FDA — Tue, 10 Nov 2009 00:00:00 +0000

The device blocks off the aorta, monitors aortic pressure, and delivers solution to stop the heart during cardiopulmonary bypass procedures.

Finish Reading: Edwards Lifesciences CardioVations EndoClamp Aortic Catheter

Penumbra Recalls the Original Version of 6F Neuron 070 Delivery Catheter

FDA — Thu, 01 Oct 2009 00:00:00 +0000

Penumbra voluntarily conducted a field removal of the devices after learning about the devices potential to kink or ovalize. FDA has been apprised of this action.

Finish Reading: Penumbra Recalls the Original Version of 6F Neuron 070 Delivery Catheter

Toyota Recalls 3.8 Million Vehicles: Gas Pedals Sticking

E. Sizemore — Wed, 30 Sep 2009 00:15:48 +0000

Toyota / Lexus are warning drivers about the potential for drivers-side floor mats to cause the accelerator (gas pedel) to stick. This recall affects 3.8 million vehicles.

Finish Reading: Toyota Recalls 3.8 Million Vehicles: Gas Pedals Sticking

Sitagliptin – Januvia and Janumet – Type Two Diabetes Drugs and Acute Pancreatitis

E. Sizemore — Fri, 25 Sep 2009 18:53:17 +0000

Based on the temporal relationship of initiating sitagliptin or sitagliptin/metformin and development of acute pancreatitis in the reviewed cases, FDA believes there may be an association between these events and the Type Two Diabetes drugs.

Finish Reading: Sitagliptin – Januvia and Janumet – Type Two Diabetes Drugs and Acute Pancreatitis

Eddie Bauer Play Yards with Rocking Bassinets Recalled Due to Suffocation Hazard

CPSC — Thu, 14 May 2009 00:00:00 +0000

THE TILTED SLEEPING SURFACE CAN CAUSE AN INFANT TO ROLL TO THE CORNER OR SIDE OF BASSINET AND BECOME WEDGED IN THE CORNER OR PRESSED AGAINST THE SIDE OR BOTTOM OF THE BASSINET.

Finish Reading: Eddie Bauer Play Yards with Rocking Bassinets Recalled Due to Suffocation Hazard

Recalled Terumo Tenderflow Pediatric Arterial Cannulae

FDA — Tue, 09 Dec 2008 00:00:00 +0000

Terumo has already received five reports in which there was difficulty removing the "introducer" from the Tenderflow cannula. The cannula must be removed and replaced if an introducer can not be removed properly. This process may lead to aortic damage, blood loss and even death.

Finish Reading: Recalled Terumo Tenderflow Pediatric Arterial Cannulae

Infant Death From Convertible Cribs by Playkids USA

CPSC — Fri, 17 Oct 2008 00:00:00 +0000

CPSC IS AWARE OF THE DEATH OF A 5-MONTH-OLD CHILD ON AUGUST 31, 2008 IN BROOKLYN, N.Y. THE CHILD BECAME ENTRAPPED BETWEEN THE MATTRESS AND THE DROP SIDE RAIL OF THE CONVERTIBLE CRIB AND SUFFOCATED.

Finish Reading: Infant Death From Convertible Cribs by Playkids USA