HIGH
FDA DEVICE
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Potential for
Recall database
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HIGH
FDA DEVICE
Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERILE, IVSTATION SYRINGE (40MMX40MM). 2. Part Number 258900029, LABEL, STERILE, IVSTATION SYRINGE...
Potential for mislabeled syringe produced by the i.v.STATION device.
Omnicell
Potential for
HIGH
HIGH
FDA DEVICE
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Ventec Life Systems
Respiratory system
HIGH
FDA DEVICE
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Resorbable bone void filler falls outside standard specifications.
Orthorebirth Co
Resorbable bone
HIGH
FDA DEVICE
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
Katalyst Surgical
Ophthalmic Tissue
HIGH
FDA DEVICE
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25-S
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Katalyst Surgical
Field Safety
HIGH
FDA DEVICE
DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Katalyst Surgical
Field Safety
HIGH
FDA DEVICE
DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Katalyst Surgical
Field Safety
HIGH
FDA DEVICE
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Katalyst Surgical
Field Safety
HIGH
FDA DEVICE
DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Katalyst Surgical
Field Safety
HIGH
FDA DEVICE
BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC
Resorbable bone void filler falls outside standard specifications.
Orthorebirth Co
Resorbable bone
HIGH
FDA DEVICE
DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Katalyst Surgical
Field Safety
HIGH
FDA DEVICE
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Katalyst Surgical
Field Safety
HIGH
FDA DEVICE
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Katalyst Surgical
Field Safety
HIGH
FDA DEVICE
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Katalyst Surgical
Field Safety
HIGH
FDA DEVICE
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Katalyst Surgical
Field Safety
HIGH
FDA DRUG
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61
MEMANTINE HYDROCHLORIDE
Failed Dissolution
HIGH
FDA DEVICE
Yeastone Broth, 11ML, 10/BOX YY3462
Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
Remel
Products may
Health & Personal Care
HIGH
FDA DRUG
Omnipaque Injection Recalled by GE Healthcare for Particulate Matter in 866,570 vials (2026)
OMNIPAQUE
Presence of