The Recall Desk

State

Hawaii product recalls

20,371 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.

14326–14350 of 20371

  • HighFDA (Devices)·Z-1029-2023·2023-02-08

    MEDLINE procedural trays recalled for potential sterile packaging breach

    MEDLINE is recalling procedural trays because sterile blades within the kits could puncture the outer foil packaging, potentially breaching the sterile barrier.

    Product
    Non-sterile procedural trays labeled as CRANI, 2 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1047-2023·2023-02-08

    Medline UNITE Foot & Ankle Drill Bit Recalled for Intra-operative Screw Failure Risk

    Medline Industries recalls 190 UNITE foot and ankle drill bits due to observed screw failure during surgery. When used to pre-drill holes for certain screw sizes, the drill bits may fail under surgical torque, creating risk during procedures.

    Product
    MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1030-2023·2023-02-08

    Non-sterile procedural trays risk sterile packaging breach

    Medline Industries is recalling non-sterile laparoscopic procedural trays containing sterile blades that may puncture the outer packaging, potentially breaching the sterile barrier. 260 cases have been distributed nationwide.

    Product
    Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1022-2023·2023-02-08

    SynCardia Total Artificial Heart System Recalled for Cannula Tears

    SynCardia Systems is recalling its Total Artificial Heart System due to reported tears in the cannula caused by wear and tear stress. Approximately 1,732 systems worldwide are affected.

    Product
    SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1034-2023·2023-02-08

    Procedural Trays with Sterile Blades May Have Damaged Packaging

    Medline Industries is recalling 45 units of procedural trays containing sterile surgical blades. The sharp blades may puncture the outer sterile packaging, potentially compromising sterility and increasing infection risk.

    Product
    Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2023·2023-02-08

    OSS Modular Arthrodesis Nail Recalled for Missing Locking Bolts

    Biomet is recalling certain OSS Modular Arthrodesis Nails due to missing locking bolts that could require extended surgery. Affected units are Lot 136620.

    Product
    OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1025-2023·2023-02-08

    Cardiopulmonary Bypass Oxygenator Recalled for Loose Temperature Monitoring Adapter

    Medtronic Perfusion Systems is recalling 1,340 units of the Affinity Fusion Oxygenator due to reports that the Temperature Monitoring Adapter can come loose during or after use in cardiopulmonary bypass procedures.

    Product
    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2023·2023-02-08

    Siemens Fluoroscopic X-ray Systems Risk of Boot Failure After Shutdown

    Certain Siemens fluoroscopic X-ray systems may only boot into backup mode after an abrupt shutdown, preventing full operation. This could necessitate cancelling or switching to alternative treatment systems.

    Product
    System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 108
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1035-2023·2023-02-08

    Non-sterile procedural knee trays recalled for potential packaging breach

    Medline Industries recalls non-sterile Total Knee procedural trays because sterile blades inside can puncture the outer foil packaging. This could compromise sterile blade integrity.

    Product
    Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1033-2023·2023-02-08

    Non-sterile orthopedic procedural trays recalled for potential sterile packaging breach

    Medline Industries recalls non-sterile orthopedic procedural trays that may contain sterile blades capable of puncturing the protective foil packaging, compromising sterile barriers.

    Product
    Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1026-2023·2023-02-08

    Affinity Fusion Oxygenator adapter may loosen during cardiac surgery

    Medtronic is recalling Affinity Fusion Oxygenators because the Temperature Monitoring Adapter may come loose during setup or disassembly of the heart-lung machine used in cardiac surgery. No injuries have been reported.

    Product
    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·23115·2023-02-08

    Fabuloso Multi-Purpose Cleaners Recalled for Bacterial Contamination Risk

    Colgate-Palmolive is recalling about 4.9 million Fabuloso Multi-Purpose Cleaners due to contamination with Pseudomonas bacteria. People with weakened immune systems, external medical devices, or underlying lung conditions face a risk of serious infection from exposure.

    Product
    Fabuloso Multi-Purpose Cleaners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1027-2023·2023-02-08

    Temperature Monitoring Adapter Detachment in Cardiopulmonary Bypass Oxygenators

    Medtronic is recalling cardiopulmonary bypass equipment because the Temperature Monitoring Adapter can come loose during setup or disassembly, potentially compromising temperature monitoring during heart surgery.

    Product
    Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1048-2023·2023-02-08

    GORE CARDIOFORM Septal Occluder Recalled for Incomplete Quality Documentation

    W L Gore & Associates is recalling 14 units of the GORE CARDIOFORM Septal Occluder (GSX0030A) due to incomplete quality test documentation. The missing verification of device release could pose a potential risk of device failure and serious complications.

    Product
    GORE CARDIOFORM Septal Occluder, REF: GSX0030A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1045-2023·2023-02-08

    MEDLINE UNITE Foot and Ankle Screw Recall: Intra-Operative Failure

    MEDLINE INDUSTRIES is recalling 420 units of UNITE Foot and Ankle surgical screws (Lot 810304) due to observed intra-operative failure when pre-drilled and implanted with excessive torque.

    Product
    MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1032-2023·2023-02-08

    Non-sterile procedural trays with potential sterile packaging breach

    Medline Industries is recalling non-sterile procedural trays containing sterile blades that may damage sterile packaging due to blade puncture risk. Lot 22IBQ980. No illnesses reported.

    Product
    Non-sterile procedural trays labeled as MAJOR/MINOR, 3 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1023-2023·2023-02-08

    Medtronic Affinity Fusion Oxygenator: Temperature Monitoring Adapter May Detach

    Medtronic is recalling 2,937 Affinity Fusion Oxygenators used in cardiac surgery because the Temperature Monitoring Adapter may detach during setup or disassembly.

    Product
    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1037-2023·2023-02-08

    Turbett Surgical Container TS1200 Recalled Due to Potential Weld Failures

    Turbett Surgical Container TS1200 units may have weld failures that could breach the sterile barrier, potentially allowing unsterile instruments to be used in medical procedures and risking infection.

    Product
    Turbett Surgical Container, TS1200: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V540000·2023-02-08

    2022-2023 Nova Bus LFS Transit Buses Battery Short Circuit Fire Risk

    Nova Bus is recalling certain 2022-2023 LFS transit buses because the high-voltage battery may develop a short circuit due to over-tightened rivnut inserts, creating a fire risk.

    Product
    NOVA BUS — 2022 NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1049-2023·2023-02-08

    Lucid TCD 2.0 Transcranial Ultrasound System Recalled for Hard Drive Failure

    The Lucid TCD 2.0 System has a faulty hard drive that causes the device to freeze and reboot. Eventually, the system becomes completely inoperable.

    Product
    Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0322-2023·2023-02-08

    Inositol dietary supplement recalled due to undeclared niacin

    Professional Complementary Health Formulas is recalling Inositol dietary supplement (Lot 1032526, UPC 4065111562) distributed in NY, OR, PA, UT, WI, and WY due to undeclared niacin. Consumers should stop using the product.

    Product
    Inositol packaged in white plastic bottle with UPC 4065111562 and labeled in part, "***PROFESSIONAL FORMULAS COMPLEMENTARY HEALTH Inositol DIETARY SUPPLEMENT 360 Capsules***Supplement Facts Serving Size: One Capsule***Inositol 920 mg***Other Ingredients: Vegetarian capsule (hypro
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0323-2023·2023-02-08

    Vitamin B Complex dietary supplement recalled due to undeclared niacin

    Professional Complementary Health Formulas, LLC recalls Vitamin B Complex dietary supplement (lot 1092715) due to undeclared niacin affecting 299 bottles distributed nationwide.

    Product
    Vitamin B Complex packaged in white plastic bottle labeled in part, "***PROFESSIONAL FORMULAS COMPLEMENTARY HEALTH Vitamin B Complex DIETARY SUPPLEMENT 60 Capsules***Supplement Facts Serving Size: One Capsule***Vitamin B1 (as thiamine Hcl) 80mg 6667% Vitamin B2 (as riboflavin) 80
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1041-2023·2023-02-08

    Biopsy marker device recalled for label and contents mismatch

    Carbon Medical Technologies recalls 550 Mammotome MammoStar biopsy markers due to a labeling error. The label identifies one product but the package contains a different marker size and shape.

    Product
    Mammotome MammoStar Biopsy Site Identified, REF STAR1401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1050-2023·2023-02-08

    Ultrasound system hard drive defect causes device freezing and failure

    FDA recall of NovaGuide Intelligent Ultrasound System due to faulty hard drive causing device freezing and eventual system failure.

    Product
    NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0 Transcranial Doppler Ultrasound (Model: NA-LUCM1)
    Category
    Medical Device
    Distribution
    Distributed nationwide