There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.
All Recalls
95,050 total recalls in our database
Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353
Siemens Medical Solutions USA
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
First Step Draco Pad, Product Number EP-4D
Madison Polymeric Engineering
This product has been contaminated with Stenotrophomonas lactiubi.
A steady upward trend in blank (u) absorbance was observed
Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000
Siemens Medical Solutions USA
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.
cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
Roche Diagnostics
There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355
Siemens Medical Solutions USA
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z
Madison Polymeric Engineering
This product has been contaminated with Stenotrophomonas lactiubi.
The potential sporadic performance problems may cause scanning workflow interruptions and unexpected user notifications resulting in diagnostic delay or need for patient rescan.
CLEO Patient Monitor /Tranquility VS Patient Monitor
Infinium Medical
The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.
Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959
Siemens Medical Solutions USA
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
Professional use flush and surface mount loudspeakers
Unknown Manufacturer
The loudspeaker's mounting components can break causing the speakers to dislodge and fall from its installed location, posing an injury hazard.
Diverter valve caps sold with Master Spas hot tubs and swim spas
Custom Molded Products, of Newnan, Ga.
The valve cap on the hot tubs and swim spas can become loose, pop off and strike a bystander, posing an impact hazard.
Everbilt Stainless Steel Door Pulls
Wellsco International Group Co. Ltd, of China
The door pulls can have sharp edges on the back, posing a laceration hazard.
Realspaceยฎ Magellan Performance Electric Height-Adjustable Desks
Unknown Manufacturer
The desk's control box has an electrical issue resulting in reverse polarity, which could pose a shock hazard.
Battery powered smoke and fire alarms
Unknown Manufacturer
The smoke alarms can have a misaligned internal switch causing the alarms to not activate properly, posing a risk of failure to alert consumers to a fire.
Cat Mobile Fireworks
Unknown Manufacturer
When ignited, the device can burst and spread sparks and pyrotechnic materials upward and outward instead of on the ground as intended, posing explosion, burn and projectile hazards to bystanders.
Loviebee children's security blankets
Unknown Manufacturer
The blanket's snaps can detach, posing a choking hazard.
Forky 11" Plush Toys
Dream International Limited, Co., of Hong Kong
The "googly" plastic eyes on the toy can detach, posing a choking hazard to young children.