Class I - Dangerous
Missing bushing on Liko M220 and M230 causing wear and potential for patient falling
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Class I - Dangerous
Potential cessation in ventilation can occur under specific conditions.
Class I - Dangerous
The firm received reports indicating PTD tip separation during use.
32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
Howmedica Osteonics
Class I - Dangerous
There is a potential for the outer Tyvek lid to de-bond from the sealed package.
Class I - Dangerous
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
The product does not have 510(k) clearance.
Class I - Dangerous
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
Veradius Unity, Model #718132
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class I - Dangerous
Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.
Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
Merete Medical GmbH
Class I - Dangerous
Incorrect marketing label (25 mm) was applied to product size 20 mm.
OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories
Olympus Corporation of the Americas
Class I - Dangerous
The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent
Exeter V40 Cemented Hip (150mm) Stem, Part Number 0580-1-440
Howmedica Osteonics
Class I - Dangerous
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.
Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110
Howmedica Osteonics
Class I - Dangerous
There is a potential for the outer Tyvek lid to de-bond from the sealed package.
The firm received reports indicating PTD tip separation during use.
Class I - Dangerous
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
The firm received reports indicating PTD tip separation during use.
The firm received reports indicating PTD tip separation during use.
Class I - Dangerous
There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the self-test. This recall occurred in 2015.
Zenition 70, Model #718133
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Class I - Dangerous
Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.
Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044
Howmedica Osteonics
Class I - Dangerous
There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem.
Class I - Dangerous
Missing bushing on Liko M220 and M230 causing wear and potential for patient falling