The Recall Desk

State

Hawaii product recalls

72,820 recalls have nationwide distribution and so reach Hawaii. 2,765 additional recalls listed Hawaii specifically in their distribution scope.

What the numbers show

Total
2,765
Critical
333
Severe
566
Most recent
2026-09-02

Of the 2,765 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 566 (20%) are Severe.

These figures cover only the 2,765 recalls whose distribution notice names Hawaii specifically. The 72,820 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

301–325 of 75585

  • SevereFDA (Drugs)·D-0745-2026·2026-08-12

    FDA Recalls Mirabegron Tablets Over Nitrosamine Impurity

    Zydus Pharmaceuticals is recalling Mirabegron extended-release tablets, 25 mg, due to an out-of-specification result for the N-Nitroso Mirabegron impurity. The recall affects nationwide distribution in the USA.

    Product
    MIRABEGRON — MIRABEGRON (MIRABEGRON)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2852-2026·2026-08-12

    Quantum Rehab 4Front Powered Wheelchair Controller Software Recall

    Pride Mobility is recalling 1,102 Quantum Rehab 4Front powered wheelchairs with controller software version 2.0.11 due to a defect that may cause unexpected brake stops or control system crashes.

    Product
    Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2900-2026·2026-08-12

    GEM Premier 5000 PAK Lysing Solution Concentration Recall

    Specific lots of the GEM Premier 5000 PAK lysing bag solution have an active ingredient concentration that does not meet manufacturing specifications, which could delay recognition and management of Co-Oximetry and total bilirubin abnormalities.

    Product
    GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0744-2026·2026-08-12

    Cyclophosphamide Injection Recall: Stainless Steel Particulate Matter Found

    Cyclophosphamide for Injection, USP, 2 gram/vial, is being recalled due to the presence of particulate matter identified as stainless steel. The recall affects 1,464 vials distributed nationwide.

    Product
    Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2857-2026·2026-08-12

    OXOS Medical Recalls MC2 Portable X-Ray Systems Over Circuit Board Overheating

    OXOS Medical Inc is recalling 77 units of the MC2 Portable X-Ray System due to a defective circuit board that overheats. The recall affects devices distributed nationwide in FL, GA, IN, SC, TX, and VA.

    Product
    Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog Number: MC2, MC2.1 Software Version: 5.7.0 Product Description: The MC2 Portable X-Ray System ( MC2 System or MC2 ) is a portable and handheld x-ray system designed to aid clinicians with po
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2876-2026·2026-08-12

    GE Healthcare MAC VU360 Electrocardiograph Software Recall

    GE Healthcare is recalling 163 MAC VU360 electrocardiograph units due to a software issue that may cause a previous patient's data to remain visible and be incorrectly associated with a subsequent patient.

    Product
    GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2909-2026·2026-08-12

    Blom-Singer Voice Prosthesis Boxes Mislabeled with Wrong Flange Type

    Freudenberg Medical is recalling 12 Blom-Singer Classic Indwelling Voice Prosthesis devices because the boxes are mislabeled, swapping Large Esophageal Flange and Large Esophageal and Tracheal Flange contents.

    Product
    Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2854-2026·2026-08-12

    Copan WASPLab Software Recall Over Results Overwrite Issue

    Copan WASP is recalling WASPLab devices due to a software issue in the WebApp that may prevent users from overwriting results. The recall affects WebApp versions 2.33.1, 2.33.3, and 2.34.2.

    Product
    Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version: WebApp version 2.33.1, 2.33.3 and 2.34.2 Product Description: WASPLab is an automated device intended to be used for the incubation and the digital imaging of agar culture plates streaked w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V526000·2026-08-12

    Nissan Recalls 2025 Altima Vehicles Due to Air Bag Fastener Defect

    Nissan is recalling 2025 Altima vehicles because incorrect mounting fasteners may prevent front passenger air bags from deploying as intended in a crash.

    Product
    NISSAN — NISSAN ALTIMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2862-2026·2026-08-12

    Stryker AHTO Tube Set Packaging Recalled for Handpiece Leaking

    Stryker is recalling 46,212 units of its AHTO Tube Set Packaging (Catalog Number 0250070600) due to reported complaints of leaking from the handpiece during use. The recall affects products distributed worldwide, including US Nationwide and multiple countries.

    Product
    STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2850-2026·2026-08-12

    Quantum Rehab Q6 Edge 4 Wheelchairs Recalled Due to Controller Software Issue

    Pride Mobility Products Corp. is recalling Quantum Rehab Q6 Edge 4 powered wheelchairs because a software issue can cause unexpected braking and potential injury.

    Product
    Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 Edge 4 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2840-2026·2026-08-12

    Radial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall

    Boston Scientific is recalling Radial Jaw 4 Jumbo Biopsy Forceps due to potential breach in the sterile barrier of device packaging. The recall affects 5,020 units in the US and 20,770 units outside the US.

    Product
    Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2856-2026·2026-08-12

    Powered Wheelchair Control Software Recall by munevo

    Munevo is recalling 19 powered wheelchair hands-free control systems due to a software issue that may cause the driving mechanism to fall out of calibration, leading to unexpected steering drift or imprecise control.

    Product
    munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smart Glasses Interface/Wheelchair Head Control System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2891-2026·2026-08-12

    Philips Allura X-Ray Systems Recalled Over Unauthorized Hard Disk Drives

    Philips is recalling 5,012 Allura interventional fluoroscopic X-ray systems nationwide due to potential loss of imaging functionality, motorized movement, or data caused by unauthorized hard disk drives.

    Product
    Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 722033. 3. Allura Xper FD10/10; Model Numbers: 722005, 722011, 722027. 4. Allura
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2897-2026·2026-08-12

    United Orthopedic U2 Knee Implant Bushings Recalled Over Engraving Design Issue

    United Orthopedic Corp. is recalling three Femoral offset bushing components of the U2 Total Knee System due to a design issue causing incorrect engraved numbering that could lead to incorrect implant orientation during surgery.

    Product
    Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2843-2026·2026-08-12

    Powered Wheelchair Controller Software Recall by Pride Mobility

    Pride Mobility is recalling 1,102 Q6 Edge 3 Stretto powered wheelchairs with controller software version 2.0.11 due to a defect that may cause unexpected brake stops or control system crashes.

    Product
    Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Number: Q6 Edge 3 Stretto Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2875-2026·2026-08-12

    Merge OrthoPACS Imaging Workstation Recall for Patient Data Display Issue

    Merge Healthcare is recalling 5 units of its Merge OrthoPACS medical imaging diagnostic workstation due to a software issue where thumbnails from a previously opened patient study may appear while a different patient study is currently open.

    Product
    Merge OrthoPACS, medical imaging diagnostic workstation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V525000·2026-08-12

    BMW Vehicles Recalled Due to Potential Loss of Power and Rollaway Risk

    BMW is recalling certain 2021–2026 BMW models because the connection between the driveshaft and rear differential may become damaged, potentially causing a loss of power or vehicle rollaway.

    Product
    BMW — BMW 750E XDRIVE, 840I, 840I XDRIVE, 540I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2858-2026·2026-08-12

    Medical Action Industries Recalls Dialysis Change Tray Kits Due to Seal Defect

    Medical Action Industries is recalling 3,740 Dialysis Change Tray Clear Sequence kits because the needle-free access device may have an improper seal.

    Product
    Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2861-2026·2026-08-12

    DASH Rapid PCR Instrument Recalled Due to Software Issue Causing False Co-infection Results

    Nuclein LLC is recalling the DASH Rapid PCR Instrument (Model SG-0002) because a software issue may result in false co-infection readings.

    Product
    Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chai
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2887-2026·2026-08-12

    HardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges

    Hardy Diagnostics is recalling HardyDisk AST Cefiderocol 30µg (Lot 543461) because incorrect cartridges may cause inaccurate susceptibility testing results.

    Product
    HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2842-2026·2026-08-12

    Quantum Outback Powered Wheelchair Controller Recalled Due to Unexpected Braking Risk

    Pride Mobility Products Corp. is recalling Quantum Outback powered wheelchairs due to a software issue that may cause unexpected braking and potential injury.

    Product
    Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Number: Quantum Outback Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2866-2026·2026-08-12

    Stryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use

    Stryker is recalling Strykeflow Suction/Irrigator PS devices due to reports of leaking from the handpiece during use.

    Product
    STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
    Category
    Medical Device
    Distribution
    Distributed nationwide