Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
All Recalls
95,089 total recalls in our database
The application may crash during the cath lab procedure.
Sterility: Due to a potential incomplete seal on the outer sterile package.
A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely.
Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464 For use with the conserve metal head
MicroPort Orthopedics
Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
MISAGO RX Self Expanding Peripheral Stem
Terumo Medical
During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape of the stent.
A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely.
Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664 For use with the conserve metal head
MicroPort Orthopedics
Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for Use (IFU).
Sterility: Due to a potential incomplete seal on the outer sterile package.
Lightning Slide stainless steel playground slide
Horizon Industries, of Columbia, Pa
The weld between the slide bedway and sidewall can crack and separate. A child's fingers can get caught in the space, posing an amputation hazard.
VIVID Red Wine Crush Gift Boxes
Unknown Manufacturer
Mold can be present on the boxes, posing a risk of respiratory or other infections in individuals with compromised immune systems, damaged lungs or an allergy to mold.
SafeHarbor vinyl impact windows
Atrium Windows and Doors Inc., of Welcome, N.C.
The glass can separate from the frame during hurricane conditions, posing an impact injury hazard.
Menorahs
Unknown Manufacturer
The menorahs can melt when the candles are burning, posing a fire hazard.
Lexibookยฎ Baby Bath Seats and Chairs
Lexibook S.A., of France
The bath seats/chairs fail to meet the federal safety standard, including requirements for stability and the bath seats can tip over while a baby is in it, posing a drowning hazard to babies.
Technical Consumer Products (TCP) LED lamps
Unknown Manufacturer
The lamps can overheat exposing an energized heat-sink and wires, posing an electrical shock hazard.
Cabot wood cleaner and wood brightener products
Unknown Manufacturer
A faulty cap seal can cause the containers to leak contents, posing a chemical hazard to consumers. Inhaling, ingesting or skin contact with the product can cause burning and other injuries.
BM Westco Sup-R-Roll Donut Mix, 50#
CSM Bakery Products NA
Undeclared allergen; Peanut Protein
Blue Bunny Ice Cream Hoppin' Holidoodle ice cream 46 fl. oz. UPC 070640014644 and UPC 070640014651 (high altitude).
Wells Enterprises
Product may be contaminated with Listeria Monocytogenes.