Class I - Dangerous
Pouches may not have been sealed during packing.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Potential for compromise of the package resulting in a breach of the sterile barrier
Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Convenience Kits, MOHS "OPENING" PROCEDURE TRAY
Avid Medical
Class I - Dangerous
Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.
Potential for compromise of the package resulting in a breach of the sterile barrier
Certain Gingihue Post Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
Healing Abutment Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Potential for compromise of the package resulting in a breach of the sterile barrier
Class I - Dangerous
Pouches may not have been sealed during packing.
Implant Cover Screw Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
IOL Abutment and Screw Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
Drill Stop Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been a PDE (Patient / Study Demographic Edit) performed after the images were ingested in PACS.
Class I - Dangerous
Pouches may not have been sealed during packing.