The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
All Recalls
92,900 total recalls in our database
Failure of fusion system instruments in the field.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
CORNEAT VISION
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
Waldemar Link GmbH & Co. KG (Mfg Site)
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
Potential for open header bag seals, compromising sterility.
TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
Omnia Medical
Failure of fusion system instruments in the field.
Replacement of the internal Sample Pump due to high failure rates.
Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:
Contract Medical International GmbH
Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.
Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/A
B.Braun Medical S.A.S.
The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Siemens Healthcare Diagnostics
Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)
Boston Scientific
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Bariatric Fusion Iron Multivitamin Bottles
VitaQuest International, LLC of Caldwell, New Jersey
The recalled multivitamins contain iron, which must be in child-resistant packaging, as required by the Poison Prevention Packaging Act. The recalled packaging of the iron-containing multivitamins violates the federal standard for child-resistant packaging because the bottle caps are not child-resistant, posing a risk of deadly poisoning, if the contents are swallowed by young children.
Paris Hilton Mini Beauty Fridges
Unknown Manufacturer
The recalled mini fridge's electrical switch can short circuit, causing it to overheat, posing a fire and burn hazard.
In My Jammers Button Up Flare Pajama Sets
Unknown Manufacturer
The recalled children's pajama sets violate mandatory standards for children's sleepwear flammability, posing a risk of burn injuries to children.
Children's Wooden Cactus Toys
Unknown Manufacturer
The recalled toy is intended for children under three years of age and contains small parts, which violates the small parts ban, posing a deadly choking hazard.
Product may be contaminated with Cesium-137 (Cs-137)