The Recall Desk

State

Hawaii product recalls

72,907 recalls have nationwide distribution and so reach Hawaii. 2,766 additional recalls listed Hawaii specifically in their distribution scope.

What the numbers show

Total
2,766
Critical
333
Severe
567
Most recent
2026-09-09

Of the 2,766 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.

These figures cover only the 2,766 recalls whose distribution notice names Hawaii specifically. The 72,907 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

851–875 of 75673

  • SevereFDA (Drugs)·D-0676-2026·2026-07-08

    Cinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels

    Cipla USA, Inc. is recalling Cinacalcet Hydrochloride 90 mg tablets (Lot #5PB0563, expiring 4/30/2027) distributed nationwide due to the presence of N-nitroso-cinacalcet above acceptable daily intake levels, a manufacturing deviation.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2672-2026·2026-07-08

    GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Recall

    W. L. Gore & Associates is recalling 467 GORE TAG Thoracic Branch Endoprosthesis Side Branch Components worldwide due to risk of catheter separation during deployment.

    Product
    GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2607-2026·2026-07-08

    Medline Convenience Kits with Swan-Ganz Catheters Recalled for Defects

    Medline is recalling convenience kits containing Swan-Ganz catheters due to failures of the proximal injectate lumen hub that can cause leaks, lumen damage, and breakage, potentially resulting in infection, medication loss, or blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ906102M VPH OPEN HEART DYNJ902664M DYNJ902664N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0653-2026·2026-07-08

    IMULDOSA injection recalled due to lack of sterility assurance

    Accord BioPharma is recalling IMULDOSA (ustekinumab-srlf) Injection due to lack of assurance of sterility. The affected lot was distributed nationwide.

    Product
    IMULDOSA — IMULDOSA (USTEKINUMAB-SRLF)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2622-2026·2026-07-08

    Surgical Convenience Kit Recalled for Bacterial Contaminant in Alcohol Prep Pads

    Windstone Medical Packaging is recalling AMS Dr. Lewin Pack surgical convenience kits (45 units) distributed nationwide because they contain Webcol alcohol prep pads contaminated with Paenibacillus phoenicis bacteria.

    Product
    A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2632-2026·2026-07-08

    CRE Wireguided 6-8mm 240cm Medical Device Recall Worldwide

    Boston Scientific Corporation is recalling the CRE Wireguided 6-8mm 240cm device worldwide due to a potential sterile breach of the packaging pouches.

    Product
    CRE Wireguided 6-8mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0658-2026·2026-07-08

    Accucaine Lidocaine Injection Recalled for Lack of Sterility Assurance

    Asclemed USA Inc. is recalling specific lots of Accucaine (Lidocaine HCl Injection USP, 1%) distributed nationwide due to lack of assurance of sterility. The affected product is distributed by Enovachem Pharmaceuticals.

    Product
    ACCUCAINE — ACCUCAINE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0649-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators distributed nationwide because unsterilized units intended for further processing were shipped to customers outside the intended distribution channel.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V438000·2026-07-08

    BMW and Toyota vehicles recalled due to engine starter fire risk

    BMW of North America, LLC is recalling various BMW and Toyota Supra models because the engine starter may overheat and catch fire.

    Product
    TOYOTA — TOYOTA, BMW SUPRA, Z4, X4, X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0643-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators that were intended for sterilization but were instead distributed unsterilized to customers outside the intended distribution channel.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0646-2026·2026-07-08

    ChloraPrep One-Step Applicators Recalled for Lack of Sterility Assurance

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, creating a lack of sterility assurance.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0660-2026·2026-07-08

    Amphetamine extended-release capsules contain immediate-release pellets after label mix-up

    Mixed amphetamine salts extended-release capsules, 5 mg, from Lannett are being recalled because the capsules contain only immediate-release pellets. 1,392 bottles affected.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2627-2026·2026-07-08

    CRE Pro Wireguided 8-10mm 240cm Medical Device Sterile Pouch Breach

    Boston Scientific is recalling CRE Pro Wireguided 8-10mm 240cm devices worldwide due to a potential sterile breach of the product packaging pouches. The breach could compromise the sterility of the devices.

    Product
    CRE Pro Wireguided 8-10mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2637-2026·2026-07-08

    CRE Wireguided 18-20mm 240cm medical devices recalled for sterile breach

    Boston Scientific Corporation is recalling CRE Wireguided 18-20mm 240cm devices worldwide due to a potential sterile breach of the pouches in which the devices are packaged.

    Product
    CRE Wireguided 18-20mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2613-2026·2026-07-08

    Medline Convenience Kits with Recalled Swan-Ganz Catheters

    Medline Convenience kits containing Swan-Ganz catheters recalled by Becton Dickinson are being recalled due to leaks and breakage of the proximal injectate lumen hub, which may result in infection, medication loss, or blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M CDS982269N CARDIAC MAJOR DYNJ901328D DYNJ901328F HEART A DYNJ903465F DYNJ903465G HEART TRAY-VASCULAR DYNJ907857 DYNJ907857A DYNJ90
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2612-2026·2026-07-08

    Medline Convenience Kits with Recalled Swan-Ganz Catheters

    Medline Convenience kits containing recalled Swan-Ganz catheters may leak or break at the proximal injectate lumen hub, risking infection, medication loss, and blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2670-2026·2026-07-08

    Radius VSM ECG Pre-connected Set Recalled for Incorrect Heart Rate Detection

    Masimo Corporation is recalling Radius VSM ECG pre-connected sets because the ECG electrode assembly may incorrectly detect extreme bradycardia or tachycardia and trigger false alarms on patients with normal heart rates, potentially distracting clinicians from true positive alarms and delaying treatment.

    Product
    Radius VSM ECG pre-connected Set, REF: 4842, 4695
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V440000·2026-07-08

    Shyft Recalls Utilimaster Velocity Vehicles Due to Strobe Light Fire Risk

    Shyft Group is recalling 2016, 2019, and 2021 Utilimaster Velocity vehicles because water entering an improperly sealed strobe light may cause a short circuit and increase the risk of fire.

    Product
    UTILIMASTER — UTILIMASTER VELOCITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2608-2026·2026-07-08

    Medline Convenience Kits with Recalled Swan-Ganz Catheters

    Medline Industries is recalling convenience kits containing Swan-Ganz catheters due to defects in the proximal injectate lumen hub that may leak or break, risking infection, medication loss, and blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE TOTE DYNJ8407
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V443000·2026-07-08

    Husqvarna and GasGas Motorcycles Recalled for Brake Caliper Cracks

    KTM North America is recalling certain 2022-2024 Husqvarna FE 501S, FE 350S, and 2024 GasGas ES 350 and ES 500 motorcycles due to a potential rear brake caliper crack that could reduce braking ability and increase crash risk.

    Product
    HUSQVARNA — HUSQVARNA, GASGAS FE 501S, ES 500, ES 350, FE 350S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2647-2026·2026-07-08

    RayCare 2024A SP4 Oncology System Beam Set Delivery Note Data Loss

    RayCare 2024A SP4 oncology information system may lose data or fail to notify users when beam set delivery notes are modified simultaneously or updated during treatment sessions.

    Product
    RayCare 2024A SP4. Oncology Information Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2606-2026·2026-07-08

    Medline Convenience Kits with Swan-Ganz Catheters Recalled

    Medline Industries is recalling convenience kits containing Swan-Ganz catheters due to leaks and breakage of the proximal injectate lumen hub, which may cause infection, medication loss, or blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYNJ68530B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2646-2026·2026-07-08

    RayCare 2024A SP1 Oncology Information System Software Recall

    RayCare 2024A SP1 oncology software may lose data if beam set delivery notes are modified simultaneously or updated during treatment sessions, with users not notified of changes.

    Product
    RayCare 2024A SP1. Oncology Information Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2609-2026·2026-07-08

    Medline Convenience Kits Containing Recalled Swan-Ganz Catheters

    Medline is recalling convenience kits containing Swan-Ganz catheters due to leaks and breakage of the proximal injectate lumen hub, which may cause infection, medication loss, or blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ905855 KIT UNIVERSITY CABG PACK DYNJ905857 OH MED RN CDS DYNJ905936B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2623-2026·2026-07-08

    GC Agar Base Culture Media Reduced Recovery of Neisseria gonorrhoeae

    Remel, Inc is recalling GC Agar Base culture media because some strains of Neisseria gonorrhoeae may not be recovered or may show reduced recovery on the product.

    Product
    GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
    Category
    Medical Device
    Distribution
    Distributed nationwide