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.

526–550 of 75585

  • HighFDA (Devices)·Z-2777-2026·2026-07-29

    Emano Flow Uroflowmetry App Recalled Over Biased Flow Estimates

    Emano Metrics is recalling 685 units of the Emano Flow smartphone-based acoustic uroflowmetry app (v2.0.0) because recordings captured at 48,000 Hz were processed by models trained on 44,100 Hz audio, producing systematically biased urinary flow rate and voided volume estimates.

    Product
    Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system. Software-only device that measures urinary flow rate and voided volume from the acoustic signal of urination. No physical components. Distributed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2757-2026·2026-07-29

    Boston Scientific Steerable Sheath Recall Over Hemostatic Valve Damage

    Boston Scientific is recalling its Faradrive Steerable Sheath devices due to potential hemostatic valve damage during preparation, which may cause air ingress and patient harm.

    Product
    FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26E050000·2026-07-29

    Toyota Recalls Side Curtain Air Bag Assemblies for Tacoma Vehicles

    Toyota is recalling side curtain air bag assemblies for 2016-2023 Tacoma vehicles because they may be improperly secured, increasing injury risk during a crash.

    Product
    AIR BAGS:SIDE/WINDOW:CURTAIN recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0709-2026·2026-07-29

    Levothyroxine Sodium Tablets Recalled Due to Subpotent Drug Concerns

    Major Pharmaceuticals is voluntarily recalling certain lots of Levothyroxine Sodium Tablets (75 mcg) because the medication may be subpotent.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2767-2026·2026-07-29

    3mensio Workstation Software Recalled Due to Inaccurate Cardiovascular Measurements

    PIE Medical Imaging B.V. is recalling 3mensio Workstation (Vascular Fenestrated) software because it may provide inaccurate cardiovascular measurements under specific conditions.

    Product
    3mensio Workstation (Vascular Fenestrated) software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2785-2026·2026-07-29

    Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Contamination

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. RR-DAVINCI PROSTATE ACCESSORY DYNJ63392F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2754-2026·2026-07-29

    FARADRIVE Steerable Sheath Clear IDE Recall for Air Embolism Risk

    Boston Scientific recalls 400 units of a cardiac catheter sheath due to potential air embolism risk from valve damage during preparation.

    Product
    FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0701-2026·2026-07-29

    Levothyroxine Sodium Tablets Recalled for Subpotency by Major Pharmaceuticals

    Major Pharmaceuticals is voluntarily recalling Levothyroxine Sodium Tablets (50 mcg) from lot N02200 due to subpotency, meaning the tablets may contain less active ingredient than labeled. Products were distributed nationwide in the USA.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2778-2026·2026-07-29

    MiniMed Go App Recalled Due to Missed Insulin Alerts

    Medtronic is recalling its MiniMed Go app because a software bug can prevent insulin dose alerts during nighttime, potentially leading to missed doses and hyperglycemia.

    Product
    MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2780-2026·2026-07-29

    Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. DAVINCI PROSTATE PACK DYNJ68477L DYNJ68477M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2776-2026·2026-07-29

    Olympus High Flow Insufflation Unit UHI-4 Recalled Due to Display and Air Delivery Failure

    Olympus Corporation of the Americas is recalling the Olympus High Flow Insufflation Unit (Model UHI-4) because the front panel display may turn off unexpectedly, causing air delivery to cease.

    Product
    Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2781-2026·2026-07-29

    Medline Urology Robotic Procedure Packs Recalled Due to Catheter Surface Contamination

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. UROLOGY ROBOTIC PROCEDURE PACK DYNJ0945779U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2786-2026·2026-07-29

    Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. SM-LAPAROSCOPIC PROSTATE PAC DYNJ61206J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2782-2026·2026-07-29

    Medline Convenience Kits Containing Bard Silastic Foley Catheters Recalled Due to Surface Material

    Medline Industries, LP is recalling 980 Medline convenience kits containing Bard Silastic Foley Catheters because excess raw material on the catheter surface may be harmful.

    Product
    Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc balloons. NON MB DAVINCI LITHOTOMY SM PK DYNJT6105
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0721-2026·2026-07-29

    ROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns

    The FDA is recalling ROHTO DRY-AID cooling eye drops due to lack of assurance of sterility. The product was distributed nationwide in the United States.

    Product
    Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0722-2026·2026-07-29

    Rohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility

    Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling certain lots of Rohto Cooling Eye Drops because the company cannot assure the sterility of the product.

    Product
    ROHTO — ROHTO (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0728-2026·2026-07-29

    Xylocaine Injection Recall Due to Hair Contamination

    Fresenius Kabi is recalling 93,250 vials of Xylocaine (lidocaine HCl) injection due to the presence of particulate matter, specifically hair found in the product.

    Product
    XYLOCAINE — XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2774-2026·2026-07-29

    Embolization devices recalled due to incorrect labeling of implant dimensions

    Micro Therapeutics, Inc. is recalling Pipeline Flex Embolization Devices because the labels may incorrectly state the implant length.

    Product
    Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20. Intracranial aneurysm flow diverter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0729-2026·2026-07-29

    FDA Recalls Xylocaine Injections Due to Hair Contamination

    FDA is recalling Xylocaine (lidocaine HCl) injections due to the presence of particulate matter, specifically hair found in the product.

    Product
    XYLOCAINE — XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2769-2026·2026-07-29

    Silent Nite Sleep Appliance Recalled Due to Lack of FDA Clearance

    Prismatik Dentalcraft, Inc. is recalling Silent Nite Sleep Appliances because the device does not have FDA clearance.

    Product
    Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep Appliance is a mandibular advancement device (MAD) intended to treat snoring and mild to moderate obstructive sleep apnea (OSA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0712-2026·2026-07-29

    FDA Recalls Amlodipine and Olmesartan Tablets Over Failed Dissolution Test

    Ascend Laboratories is recalling 6,192 bottles of Amlodipine and Olmesartan Medoxomil tablets nationwide due to failed dissolution specifications and Olmesartan content below specifications.

    Product
    AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0736-2026·2026-07-29

    Drug Recall: Dabigatran Etexilate Capsules 150 mg by Ascend Laboratories

    Ascend Laboratories is recalling 2,717 cartons of Dabigatran Etexilate Capsules, 150 mg, because stability testing found impurities above specification.

    Product
    DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
    Category
    Drug
    Distribution
    Distributed nationwide