State

Hawaii product recalls

72,971 recalls have nationwide distribution and so reach Hawaii. 2,767 additional recalls listed Hawaii specifically in their distribution scope.

What the numbers show

Total: 2,767
Critical: 333
Severe: 567
Most recent: 2026-09-16

Of the 2,767 recalls naming Hawaii we have scored against our rubric, 333 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 567 (20%) are Severe.

Which agencies issued them

These figures cover only the 2,767 recalls whose distribution notice names Hawaii specifically. The 72,971 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5426–5450 of 75738

HighFDA (Devices)·Z-2505-2025·2025-09-10
MediHoney paste tubes 31505 recalled over packaging failures affecting sterility
MediHoney Paste, catalog number 31505, is recalled after packaging failures were identified that could lead to a breach in the sterile barrier. 15,441 units are affected.
Product
Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number: 31505 Product Description: MediHoney¿ Paste with Active Leptospermum Honey is a moist dressing made of 100% Active Leptospermum medical grade Honey. The dressing helps maintain a moist environment con
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0608-2025·2025-09-10
Compounded semaglutide 0.8 mL vials recalled after testing subpotent
Semaglutide 2.5 mg/mL injection, 0.8 mL, from Boothwyn Pharmacy is recalled nationwide as a subpotent drug. 186 vials are affected.
Product
Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2513-2025·2025-09-10
External fixation universal joints recalled because pins may become dislodged
Medshape Universal Joints, REF DNE-9000-UJ, are recalled because a pin in the bone external fixation system can become dislodged, causing frame instability. 849 units are affected.
Product
Medshape Universal Joints, REF: DNE-9000-UJ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2503-2025·2025-09-10
Interventional imaging systems recalled because single phase UPS may fail on power loss
Philips Allura systems configured with a 1 Phase UPS are recalled because they may shut down and/or fail to start up if power to the system is lost. 1,006 units are affected.
Product
Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2495-2025·2025-09-10
RayStation 2023B and 2024A software recalled over non-unique DICOM identifiers
RayStation 2023B, 2024A and 2024A SP3 radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.
Product
RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version: 15.0.0.430. 3. RayStation 2024A SP3, Software Version: 15.1.3.10. Product Description: Radiation Therapy Treatment Plannin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2491-2025·2025-09-10
RayStation 11A planning software recalled over non-unique DICOM instance identifiers
RayStation 11A and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.
Product
RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pack 1, Software Version: 11.0.1.29. 3. RayStation 11A Service Pack 2, Software Version: 11.0.3.116. 4. RayStation 11A Service Pack 3, Softw
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2514-2025·2025-09-10
Dental titanium bases recalled because the post is oriented 180 degrees off
NobelBiocare Tri-Lobe-compatible WP 6.0mm engaging titanium bases, lot 277097, are recalled because the base was manufactured 180 degrees around the post from the correct position. 11 units are affected.
Product
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2493-2025·2025-09-10
RayStation 12A planning software recalled over duplicate DICOM instance identifier risk
RayStation 12A and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.
Product
RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Service Pack 2, Software Version: 13.1.1.89. Product Description: Radiation Thera
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2516-2025·2025-09-10
Spinal implant inserters recalled over potential missing pins at the tip
TOPS Inserters, model 82889, part of the TOPS System Instrument Set, are recalled because of the potential for missing pins at the tip of the inserter. 30 units are affected.
Product
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2504-2025·2025-09-10
Fluoroscopic X-ray systems recalled over air baffle missing from internal PCs
Philips Allura Xper interventional fluoroscopic X-ray systems are recalled because an air baffle component may be missing in some Nehalem FlexVision-2 PCs. 192 units are affected.
Product
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. Allura Xper FD20, Model Number 722006. 4. All
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0617-2025·2025-09-10
Chlorpromazine 50 mg tablets recalled over micro-organism on packaging coil
Amneal chlorpromazine hydrochloride tablets, 50 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.
Product
CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2492-2025·2025-09-10
RayStation 11B software recalled over non-unique DICOM instance identifiers
RayStation 11B and its service packs are recalled because DICOM instance identifiers from the RayGateway interface to Accuray's iDMS are not guaranteed to be unique.
Product
RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. 3. RayStation 11B Service Pack 2, Software Version: 12.0.3.68. 4. RayStation 11B Service Pack 3, Soft
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0607-2025·2025-09-10
Compounded fluorescein ophthalmic solution recalled after testing subpotent in one lot
Fluorescein 2% Ophthalmic, 3 mL, from Boothwyn Pharmacy is recalled nationwide as a subpotent drug. 8 vials are affected.
Product
Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2488-2025·2025-09-10
RayStation 8B and 9A software recalled over DICOM identifier uniqueness defect
RayStation 8B, its service packs and 9A radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.
Product
RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B Service Pack 2, Software Version: 8.1.2.5. 4. RayStation 9A, Software Version: 9.0.0.113.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2518-2025·2025-09-10
Hemodynamic recording systems recalled over pressure sensor error during blood pressure measurement
Merge Hemo systems are recalled because certain Schiller ARGUS PB-3000 patient data modules trigger a Pressure Sensor Defective error during non-invasive blood pressure measurement above 240 mmHg. 84 units are affected.
Product
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood fl
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0616-2025·2025-09-10
Chlorpromazine 25 mg tablets recalled after micro-organism found on packaging coil
Amneal chlorpromazine hydrochloride tablets, 25 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.
Product
CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2500-2025·2025-09-10
Uric acid meter kits recalled for distribution without premarket clearance
Blood Uric Acid Monitoring System kits, model eB-U01, are recalled because the products were distributed without premarket clearance or approvals. 2,240 units are affected.
Product
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2494-2025·2025-09-10
RayStation 6 service packs recalled over DICOM identifier uniqueness defect
RayStation 6 Service Packs 1, 2 and 3 radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.
Product
RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Service Pack 2, Software Version: 6.2.0.7. 3. RayStation 6 Service Pack 3, Software Version: 6.3.0.6. Product Description: Radiation Thera
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2498-2025·2025-09-10
LIFEPAK 1000 defibrillators recalled over inspections missed after unit servicing
Three LIFEPAK 1000 defibrillators are recalled because required inspections were not performed on units that had gone through servicing.
Product
LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardio
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2490-2025·2025-09-10
RayStation 10B planning software recalled over DICOM identifiers not guaranteed unique
RayStation 10B and 10B Service Pack 1 radiation therapy treatment planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.
Product
RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2497-2025·2025-09-10
LIFEPAK 15 defibrillators recalled because post-service inspections were not performed
Four LIFEPAK 15 defibrillators are recalled because required inspections were not performed on units that had gone through servicing.
Product
LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-2-000099 / 99577-000093 / 883873979020 V15-2-001603 / 99577-001256 / 883873911631 LIFEPAK 15: The LP15 is intended for use by trained
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2489-2025·2025-09-10
RayStation 9B and 10A software recalled over non-unique DICOM identifiers
RayStation 9B, 9B SP1, 10A and 10A service pack radiation therapy planning software is recalled because DICOM instance identifiers from the RayGateway interface are not guaranteed to be unique.
Product
RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1, Software Version: 9.2.0.483. 3. RayStation 10A, Software Version: 10.0.0.1154. 4. RayStation 10A Service Pack 1, Software Version: 10.0
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0619-2025·2025-09-10
Chlorpromazine 200 mg tablets recalled over micro-organism on packaging component
Amneal chlorpromazine hydrochloride tablets, 200 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.
Product
CHLORPROMAZINE HYDROCHLORIDE — CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2499-2025·2025-09-10
Defibrillator recalled because required post-service inspections were not performed
One LIFEPAK CR2 defibrillator is recalled because required inspections were not performed on units that had gone through servicing.
Product
LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest. The patient must be unresponsive (unconscious), not breathin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2501-2025·2025-09-10
Uric acid monitoring kits recalled over missing premarket clearance or approval
A second lot group of Blood Uric Acid Monitoring System kits, model eB-U01, covering all lots made up to June 20, 2022, is recalled for distribution without premarket clearance. 2,580 units are affected.
Product
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Category
Medical Device
Distribution
Distributed nationwide