Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
Class I - Dangerous
Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Class I - Dangerous
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
Class I - Dangerous
Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.
Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
Ultroid Technologies
Class I - Dangerous
Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)
Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
Class I - Dangerous
A limited number of product pouches may not have been sealed during packaging.