State

Hawaii product recalls

20,324 recalls have nationwide distribution and so reach Hawaii. 0 additional recalls listed Hawaii specifically in their distribution scope.

About recalls in Hawaii

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Hawaii consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

11801–11825 of 20324

HighFDA (Devices)·Z-2487-2023·2023-09-06
Intra-Aortic Balloon Pumps Fiber Optic Sensor Input Failure Recalled
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps because users reported failure of the fiber optic sensor input when inserting the balloon connector. This could affect proper device operation.
Product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1134-2023·2023-09-06
OxyTOCIN IV Bags Recalled for Lack of Sterility Validation
Central Admixture Pharmacy Services is recalling 298 bags of oxyTOCIN 40 units IV bags nationwide due to lack of validation data for sanitization cycles, creating potential sterility concerns.
Product
oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2502-2023·2023-09-06
Olympus Bronchovideoscope Recalled Due to Oversized Diameter
Olympus is recalling two models of bronchovideoscope (Models BF-3C40 and BF-N20) because the endoscope diameter is too large and may become lodged in the endotracheal tube connector.
Product
Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2494-2023·2023-09-06
Olympus Bronchovideoscope Recall Due to Device Lodging Risk
Olympus is recalling Bronchovideoscope Models BF-UC180F and BF-UC190F because the device diameter is too large and can become lodged in the endotracheal tube connector. Healthcare facilities should discontinue use and contact Olympus.
Product
Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2486-2023·2023-09-06
Cardiosave Hybrid Intra-Aortic Balloon Pump Fiber Optic Sensor Failure
Datascope Corp. is recalling 9,379 Cardiosave Hybrid Intra-Aortic Balloon Pumps due to a fiber optic sensor failure that may occur when inserting the balloon connector.
Product
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-08
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2472-2023·2023-09-06
Siemens Atellica CH LDL Cholesterol analyzer reagent carryover issue
Siemens is recalling Atellica CH analyzers due to potential reagent carryover that can cause falsely elevated results in cholesterol, bilirubin, and liver enzyme tests. This could affect the accuracy of patient laboratory results.
Product
Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin, EDTA, sodium heparin Test Code: LDLC Siemens Material Number (SMN): 11537214
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1128-2023·2023-09-06
Phenylephrine IV Injection Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls phenylephrine IV bags nationwide because the manufacturer lacks validated sanitization data to ensure sterility. Healthcare providers should identify and quarantine affected inventory.
Product
PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2485-2023·2023-09-06
Philips Wireless Foot Switch for X-Ray Systems Risks Loss of Function During Procedures
Philips is recalling wireless foot switches used with Allura Xper and Azurion X-ray systems because they may become unavailable during procedures. Approximately 1,865 units were distributed worldwide.
Product
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1108-2023·2023-09-06
FDA Recalls Cardioplegia Solution Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 184 units of Cardioplegia Solution nationwide due to lack of validation data for sterilization cycles, which compromises sterility assurance in this injectable cardiac medication.
Product
CARDIOPLEGIA SOLUTION, 60 mEq K, Induction 4:1, HIGH POTASSIUM, Total Volume = 830 mL, EVA Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0100-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2473-2023·2023-09-06
Diagnostic reagent kit recall: potential test result inaccuracy
Siemens is recalling Atellica CH diagnostic reagent kits due to potential reagent carryover that could produce inaccurate test results. This may affect quality control and patient test reliability.
Product
Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma (lithium heparin Test Code: GGT Siemens Material Number (SMN): 11097597
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1127-2023·2023-09-06
FDA Recalls Phenylephrine IV Bags Due to Unvalidated Sanitization
Central Admixture Pharmacy Services is recalling 292 bags of phenylephrine IV solution due to unvalidated sanitization cycles that cannot assure product sterility. No illnesses have been reported.
Product
PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1130-2023·2023-09-06
Epinephrine IV Bags Recalled Due to Lack of Sanitization Validation
Central Admixture Pharmacy Services is recalling epinephrine IV bags (Lot 36-260047) because sanitization processes lacked adequate validation data. The manufacturer cannot confirm the product meets sterility standards required for injectable medications.
Product
EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1107-2023·2023-09-06
FDA Recalls Cardioplegia Solution Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 304 bags of cardioplegia solution nationwide due to lack of validation data for sterilization cycles.
Product
CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2491-2023·2023-09-06
Olympus Bronchovideoscope Models Recalled Due to Lodging Risk in Connectors
Olympus is recalling 1,072 units of Bronchovideoscope Models BF-MP160F, BF-XP160F, and BF-XP60 distributed nationwide. The devices can become lodged in the endotracheal tube connector due to oversized endoscope diameter.
Product
Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1112-2023·2023-09-06
Cardioplegia Solution Recalled for Lack of Sterility Validation
Central Admixture Pharmacy Services is recalling 786 bags of Cardioplegia Solution del Nido Formula nationwide due to lack of validation data for sanitization cycles, which affects sterility assurance.
Product
Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Rx Only, Central Admixture Pharmac
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2471-2023·2023-09-06
Laboratory diagnostic test may produce inaccurate results from reagent carryover
Siemens is recalling the Atellica CH Total Bilirubin diagnostic test because reagent carryover on the analyzer could produce falsely elevated results affecting multiple related lab tests.
Product
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2484-2023·2023-09-06
Oculus Myopia Master optical device recalled for insufficient anti-reflective coating
Oculus Optikgeraete GMBH is recalling 173 units of the Oculus Myopia Master optical measurement device due to insufficient anti-reflective coating that may cause incorrect axial length measurements.
Product
Oculus Myopia Master , Ref 68100, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1109-2023·2023-09-06
Cardioplegia Solution Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 84 bags of Cardioplegia Solution (Lot #36-262515) due to lack of validation data for sanitization cycles, creating uncertainty about sterility standards for this injectable product.
Product
CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2497-2023·2023-09-06
Olympus Bronchovideoscope Model BF-MP190F Recall for Oversized Diameter
Olympus Corporation recalls 441 Bronchovideoscope Model BF-MP190F units. The endoscope's diameter is too large, causing it to become lodged in the endotracheal tube connector.
Product
Olympus Bronchovideoscope, Models BF-MP190F.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2512-2023·2023-09-06
Phoroptor VRx Digital Refraction System head detachment hazard recall
Reichert's Phoroptor VRx Digital Refraction System head may detach from its mounting bracket and fall onto patients or operators. The recall affects 87 units distributed nationwide.
Product
PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye. MODEL NUMBER: 16242 [Model 16241 is the base model. Model 16242 includes an additional prism feature used for the measurement of ocular deviation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1110-2023·2023-09-06
Cardioplegia Solution Recalled for Unvalidated Sterilization Process
Central Admixture Pharmacy Services is recalling a cardioplegia solution nationwide due to lack of validated sterilization processes used during its manufacture.
Product
CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1138-2023·2023-09-06
dilTIAZem IV Bags Recalled Due to Lack of Sterilization Validation
Central Admixture Pharmacy Services is recalling 703 bags of dilTIAZem 125mg IV medication due to lack of validated sterilization processes. Healthcare providers and patients should verify lot numbers.
Product
dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2498-2023·2023-09-06
Olympus Bronchovideoscope Recalled Due to Lodging Risk in Airway
Olympus is recalling Bronchovideoscope Model BF-XT190 units because the device diameter is too large, causing the endoscope to become lodged in endotracheal tube connectors.
Product
Olympus Bronchovideoscope, Models BF-XT190.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1137-2023·2023-09-06
Diltiazem IV Bag Recalled Due to Lack of Sterilization Assurance
Central Admixture Pharmacy Services is recalling 235 bags of diltiazem IV product due to lack of validation data for sanitization cycles. No illnesses have been reported.
Product
dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1124-2023·2023-09-06
Phenylephrine Injectable Syringes Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 4,100 syringes of phenylephrine injectable solution due to inadequate validation of sterilization cycles. The lack of documented sterilization assurance creates potential for microbial contamination.
Product
PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1
Category
Drug
Distribution
Distributed nationwide