Warning
Class II
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Wells Pharma of Houston LLC
FDA Recalls
Page 21 of 40 · 1,986 total recalls
Recalls — Page 21
Warning
Class II
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Wells Pharma of Houston LLC
Warning
Class II
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15
cGMP deviations.
Wells Pharma of Houston LLC
Warning
Warning
Class II
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
cGMP deviations.
Wells Pharma of Houston LLC
Warning
Class II
ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector...
Erbe Medical
Warning
Class II
ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector...
Erbe Medical
Warning
Class II
ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector...
Erbe Medical
Warning
Class II
Philips Azurion
Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling...
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Warning
Class II
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not...
Boston Scientific Corporation
Warning
Class II
LUX-Dx II Plus
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not...
Boston Scientific Corporation
Warning
Class II
Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number
Ten complaints have been received identifying issues at the time of use related to the package seal, including...
Zimmer
Warning
Class II
Prazosin Hydrochloride Capsules
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP)...
Appco Pharma LLC
Warning
Class II
Prazosin Hydrochloride Capsules
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP)...
Appco Pharma LLC
Warning
Class II
Prazosin Hydrochloride Capsules
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP)...
Appco Pharma LLC
Warning
Class II
Vital Nutrients Aller-C (vitamin C, citrus bioflavonoids, isoquercitrin, and bromelain)100 count bottles and 200 count
Contains undeclared egg, soy, and hazelnut
Blueroot Health
Warning
Class II
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Edwards Lifesciences
Warning
Class II
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
Micro-X Ltd.
Critical
Class I
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits
Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an...
North American Rescue LLC.
Warning
Class II
Straumann n!ce PMMA Full-arch Restoration
Includes an incorrect screw seat interface.
Straumann USA LLC
Warning
Class II
Straumann n!ce Zr, HT, Full-arch Restoration
Includes an incorrect screw seat interface.
Straumann USA LLC
Warning
Class II
Alain MILLIAT; MARMELADE ORANGE; 300 g 10.6 oz; packaged in glass jars
Product may contain foreign objects, specifically glass.
FINESALER LLC
Warning
Class II
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health...
GE Medical Systems
Warning
Class II
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health...
GE Medical Systems
Warning
Class II
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health...
GE Medical Systems
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
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