Warning
Class II
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health...
GE Medical Systems
FDA Recalls
Page 20 of 39 · 1,907 total recalls
Recalls — Page 20
Warning
Class II
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health...
GE Medical Systems
Warning
Class II
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health...
GE Medical Systems
Warning
Class II
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health...
GE Medical Systems
Warning
Class II
Pantoprazole Sodium
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have...
Hetero Labs Limited (Unit V)
Warning
Class II
Top Lid Label: Einstein Bros Bagels Honey Almond Double-Whipped Shmear
Undeclared allergen (almond).
Schreiber Foods Inc
Warning
Class II
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
Spacelabs Healthcare
Warning
Class II
Zarlengo's Chocolate Chocolate Chip Gelato packaged in multiple sizes
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.
Zarlengo Italian Ice
Warning
Class II
Zarlengo's Chocolate Gelato packaged in multiple sizes
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.
Zarlengo Italian Ice
Warning
Class II
Zarlengo's Double Dark Chocolate Gelato packaged in 1 Gallon bucket/pail - white round food and freezer grade
Soy Lecithin listed in ingredients statement, but Soy is not mentioned in the contains statement.
Zarlengo Italian Ice
Warning
Class II
Crab Cakes various sizes sold to food service
May be temperature abused, which may result in growth of Clostridium botulinum
Connecticut Crab Company LLC
Warning
Class II
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm
Potential for product to contain foreign matter, confirmed to be inspect fragments.
Davol
Warning
Class II
Bombay Kitchen brand Punjabi Mix
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40
Ethnic Foods Inc
Warning
Class II
Bombay Kitchen brand Tikka Sev
Product(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40
Ethnic Foods Inc
Info
Class III
Heraeus, PALAMIX uno
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing...
Heraeus Medical GmbH (Dental Division)
Info
Class III
Heraeus, PALAMIX duo
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing...
Heraeus Medical GmbH (Dental Division)
Warning
Class II
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
Warning
Class II
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
Warning
Class II
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
Warning
Class II
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
Warning
Class II
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
Warning
Class II
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
Warning
Class II
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
Warning
Class II
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
Warning
Class II
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
Warning
Class II
DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
Field Safety Corrective Action for IFU in DEX Forceps and Scissors.
Katalyst Surgical
Warning
Class II
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
Warning
Class II
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27
Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping,...
Katalyst Surgical
Warning
Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Warning
Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Warning
Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Warning
Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Warning
Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Warning
Warning
Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Warning
Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Warning
Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Warning
Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Warning
Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Warning
Class II
OER-ELITE Endoscope Reprocessor Connecting Tubes
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Olympus Corporation of the Americas
Critical
Class I
Rolls of label stock used with the Omnicell i.v.Station
Potential for mislabeled syringe produced by the i.v.STATION device.
Omnicell
Warning
Class II
BioCera Fibers
Resorbable bone void filler falls outside standard specifications.
Orthorebirth Co Ltd
Warning
Class II
ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z
Resorbable bone void filler falls outside standard specifications.
Orthorebirth Co Ltd
Warning
Class II
Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%)
Lack of Assurance of Sterility
Preferred Pharmaceuticals
Warning
Class II
Oxoid Agglutinating Sera, Salmonella 9-0 R30957301
Affected lots are not performing to IFU criteria showing cross reactions with 2-0 within 60 seconds....
Remel Europe Ltd.
Warning
Class II
Fluocinonide
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted...
SUN PHARMACEUTICAL INDUSTRIES INC
Warning
Class II
Fluocinonide
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted...
SUN PHARMACEUTICAL INDUSTRIES INC
Warning
Class II
Fluocinonide
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted...
SUN PHARMACEUTICAL INDUSTRIES INC
Critical
Class I
VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under...
Ventec Life Systems