The Recall Desk

State

Hawaii product recalls

72,936 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 72,936 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3076–3100 of 75702

  • HighFDA (Food)·H-0537-2026·2026-02-25

    Liquid Dietary Supplements Recalled Due to Undeclared Milk Allergen

    Pure Solutions, Inc. is recalling Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset because the labels do not declare milk as an allergen.

    Product
    Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset, Net Wt., 1 fl oz (30 ml) liquid dietary supplement, Glass bottle with dropper cap. (Individual 1 fl oz bottles (not sold in case lots)
    Category
    Food
    Distribution
    36 states
  • HighFDA (Devices)·Z-1383-2026·2026-02-25

    Bronchoscopy robots recalled over arms that may move toward patient-left

    Auris Health is recalling 173 MONARCH Platform bronchoscopy systems because a software restart can re-initialize the system to patient-left, leading to unanticipated robotic arm positioning.

    Product
    MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2026·2026-02-25

    Olympus Thunderbeat 5 mm 35 cm Surgical Device Recalled Due to Adverse Events

    Olympus Corporation of the Americas is removing Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip Type S devices due to reports of adverse events.

    Product
    Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1396-2026·2026-02-25

    GI endoscopy kits recalled over sterilization equipment calibration issues

    Medline is recalling 23,238 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1405-2026·2026-02-25

    General closure kits recalled over sterilization equipment calibration issues

    Medline is recalling 108 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1380-2026·2026-02-25

    Olympus Thunderbeat 5 mm 35 cm Inline Grip Medical Device Recall

    Olympus Corporation of the Americas is recalling Olympus Thunderbeat 5 mm, 35 cm, Inline Grip devices due to reports of adverse events.

    Product
    Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1366-2026·2026-02-25

    Medline Industries IV Administration and Extension Sets Recalled Due to Potential Leaks

    Medline Industries, LP is recalling various IV administration and extension sets because male luer connectors may leak, crack, or break during use.

    Product
    Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1364-2026·2026-02-25

    Medihoney Calcium Alginate Dressings Recalled Due to Potential Sterile Barrier Breach

    Integra LifeSciences Corp. is recalling certain Medihoney Calcium Alginate dressings because packaging failures could lead to a breach in the sterile barrier.

    Product
    MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26C002000·2026-02-25

    Evenflo Recalls LiteMax Child Seats Due to Incorrect Spanish Manual

    Evenflo is recalling LiteMax Factory Select child seats because the Spanish manual lists incorrect weight and height limits, which could lead to improper restraint.

    Product
    EQUIPMENT:OTHER:OWNERS/SERVICE/OTHER MANUAL recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1417-2026·2026-02-25

    Medline C-Section Surgical Kits Recalled Over Sterilization Calibration

    Medline is recalling 4,525 C-section convenience kits worldwide due to calibration issues with sterilization and packaging equipment that could affect sterility assurance.

    Product
    Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1374-2026·2026-02-25

    Olympus Thunderbeat 5 mm 45 cm Front-Actuated Grip Medical Device Recall

    Olympus Corporation of the Americas is removing Olympus Thunderbeat 5 mm, 45 cm Front-Actuated Grip devices due to reports of adverse events.

    Product
    Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1421-2026·2026-02-25

    Spinal and hip kits recalled over sterilization equipment calibration issues

    Medline is recalling 117,907 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1389-2026·2026-02-25

    Arteriogram and catheter kits recalled over sterilization calibration issues

    Medline is recalling 30,958 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4A; 4) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4B; 5) VEIN PROCEDURE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1395-2026·2026-02-25

    Major laparotomy kits recalled over sterilization equipment calibration issues

    Medline is recalling 82,597 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1384-2026·2026-02-25

    Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues

    Medline Industries, LP is recalling certain Medline Convenience Kits because equipment calibration issues may have impacted the sterility assurance level of the products.

    Product
    Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number: DYNJ905567A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1376-2026·2026-02-25

    Olympus Thunderbeat 5 mm Front-Actuated Grip Medical Device Recall

    Olympus Corporation of the Americas is removing Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip devices due to reports of adverse events.

    Product
    Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1412-2026·2026-02-25

    Medline Convenience Kits Recalled Due to Potential Sterility Assurance Issues

    Medline Industries, LP is recalling specific Medline Convenience Kits (CHEST/BREAST-LF) because equipment calibration issues may have impacted the sterility assurance level of the products.

    Product
    Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1419-2026·2026-02-25

    Robotic surgery kits recalled over sterilization equipment calibration issues

    Medline is recalling 7,725 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 5) KIT ROBOTICS UROLOGY PROSTA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1363-2026·2026-02-25

    MediHoney wound gel recalled over potential packaging failures

    Integra LifeSciences is recalling 49,367 units of MediHoney Gel with Active Leptospermum Honey over potential packaging failures that could breach the sterile barrier.

    Product
    MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1391-2026·2026-02-25

    PICC line and code cart kits recalled over sterilization calibration issues

    Medline is recalling 5,346 units of convenience kits because calibration issues with the equipment used to sterilize and package them may affect the sterility assurance level.

    Product
    Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268B; 3) CODE CART ADULT 4 CENTRAL LINE, Model Number: ACC010268C; 4) TRAY 6 CENTRAL LINE A, Model Number: ACC010487; 5) PEDS PICC INSERTION TRAY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1379-2026·2026-02-25

    Olympus Thunderbeat Grip Medical Device Recall for Adverse Events

    Olympus Corporation is recalling 30 Thunderbeat 5 mm, 45 cm Inline Grips due to continued reports of adverse events during medical procedures.

    Product
    Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1386-2026·2026-02-25

    Medline Convenience Kits and CPNB Setup Trays Recalled Due to Sterilization Calibration Issues

    Medline Industries is recalling 779 units of convenience kits and setup trays due to potential sterility assurance issues from equipment calibration problems during manufacturing.

    Product
    Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN MGMT, Model Number: DYNJ56436B; 3) CPNB SETUP TRAY, Model Number: DYNJRA1979; 4) CPNB SETUP TRAY, Model Number: DYNJRA1979A; 5) CPNB SETUP TRAY, Model Number: SAMPA0108
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1420-2026·2026-02-25

    Medline Medical Device Kits Recalled Due to Sterilization Calibration Issues

    Medline Industries is recalling 4,853 medical device kits due to potential sterility issues from equipment calibration problems during manufacturing.

    Product
    Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104A; 3) KIT OPHTHALMOLOGY CORNEAL TRAN, Model Number: DYKMBNDL159; 4) KIT OPHTHALMOLOGY CATARACT, Model Number: DYKMBNDL180; 5) K
    Category
    Medical Device
    Distribution
    Distributed nationwide