The Recall Desk

State

Hawaii product recalls

72,919 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 72,919 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

2601–2625 of 75685

  • HighFDA (Devices)·Z-1607-2026·2026-04-01

    I.T.S. hand locking plates heat more in MRI than instructions state

    I.T.S. GmbH is recalling the HLS Hand Locking Plates System because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1630-2026·2026-04-01

    Orthalign knee drill plates may allow a bone cut exceeding specification

    Orthalign is recalling one lot of the Trimax Pegged Drill Plate for the Lantern Knee System because plates manufactured out of specification can result in a bone cut in excess of 0.0800 inches.

    Product
    Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1610-2026·2026-04-01

    Olympus endoscope suction valve no longer compatible with named reprocessors

    Olympus is recalling the MAJ-1443 Endoscope Suction Valve because the MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

    Product
    Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2026·2026-04-01

    GE Imactis CT navigation may show needle trajectory that differs from actual

    GE Medical Systems is recalling the Imactis CT-Navigation System because of a potential discordance between the simulated needle trajectory and tip position and the actual trajectory and tip position.

    Product
    Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1612-2026·2026-04-01

    Olympus OER-Elite reprocessor no longer compatible with two valve models

    Olympus is recalling the OER-Elite Endoscope Reprocessor because the MAJ-1443 and MAJ-1444 air/water valves are no longer reprocessing compatible with the OER-Pro and OER-Elite reprocessors.

    Product
    Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1604-2026·2026-04-01

    I.T.S. distal ulna plates heat more in MRI than instructions state

    I.T.S. GmbH is recalling the Distal Ulna Locking and Ulna Osteotomy Locking Systems because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.

    Product
    I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1640-2026·2026-04-01

    Olympus PK cutting forceps jaws may break from defective welds

    Olympus is recalling PK Cutting Forceps because a supplier did not adequately validate the welding process, and defective welds can cause the forceps jaw to break during clinical use.

    Product
    Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Number: PK-CF0533 Product Description: An assembly of devices intended to generate and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation dur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1638-2026·2026-04-01

    Olympus Everest bipolar forceps model 3005 jaws may break

    Olympus is recalling Everest Bipolar Cutting Forceps model 3005 because a supplier did not adequately validate the welding process, and defective welds can cause the jaw to break during clinical use.

    Product
    Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Catalog Number: 3005 Product Description: The OLYMPUS Everest Bipolar Cutting Forceps are intended to be passed through a 5 mm cannula. Coagulation is achieved u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2026·2026-04-01

    I.T.S. calcaneus repair plate heats more in MRI than stated

    I.T.S. GmbH is recalling the FR.O.H. Calcaneus Repair System anterolateral calcaneus plate because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.

    Product
    FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1613-2026·2026-04-01

    Olympus OER-Pro reprocessor no longer compatible with two valve models

    Olympus is recalling the OER-Pro Endoscope Reprocessor because the MAJ-1443 and MAJ-1444 air/water valves are no longer reprocessing compatible with the OER-Pro and OER-Elite reprocessors.

    Product
    Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1605-2026·2026-04-01

    I.T.S. foot locking plates heat more in MRI than stated

    I.T.S. GmbH is recalling the FLS Foot Locking Plates System and HOL Hallux Osteotomy Locking Plate because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.

    Product
    FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 373
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1597-2026·2026-04-01

    I.T.S. olecranon plates heat more in MRI than instructions state

    I.T.S. GmbH is recalling Olecranon Plates with Angular Stability because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9. 2. Olecranon Plate; Article Numbers: 21111-6, 21111-8, 21111-12.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2026·2026-04-01

    I.T.S. clavicle plates heat more in MRI than instructions state

    I.T.S. GmbH is recalling Clavicula Plates with Angular Stability because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1609-2026·2026-04-01

    Beckman Coulter MicroScan gram-negative panels may contain contaminated wells

    Beckman Coulter is recalling one lot of MicroScan Neg MIC 56 panels due to the likely presence of contamination in one or more wells.

    Product
    MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2026·2026-04-01

    I.T.S. distal humeral plates heat more in MRI than stated

    I.T.S. GmbH is recalling Distal Humeral Plates with Angular Stability because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 373
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1632-2026·2026-04-01

    Straumann custom abutments made from wrong bar material after mix-up

    Straumann is recalling Custom Abutment Ti for Straumann RC because a material mix-up meant titanium abutments were manufactured from TAN bar material instead of Titanium Grade 4.

    Product
    Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V207000·2026-04-01

    Mack Recalls 2025-2027 Trailers Due to Turn Signal Software Defect

    Mack Trucks is recalling 2025-2027 Pioneer and 2027 Anthem trailers because turn signals may not function properly, increasing crash risk.

    Product
    MACK — MACK PIONEER PR (4), ANTHEM AN (4)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2026·2026-04-01

    I.T.S. proximal humeral plates heat more in MRI than stated

    I.T.S. GmbH is recalling the Humeral Head Plate with Angular Stability because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V209000·2026-04-01

    Audi Q3 recalled over remote sunroof closing from out of sight

    Volkswagen Group of America is recalling 6,077 Audi Q3 vehicles because incorrect software may allow remote sunroof closing from a distance where the operator cannot clearly see the sunroof.

    Product
    AUDI — AUDI Q3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1641-2026·2026-04-01

    Olympus HALO PKS cutting forceps jaws may break from defective welds

    Olympus is recalling HALO PKS Cutting Forceps because a supplier did not adequately validate the welding process, and defective welds can cause the forceps jaw to break during clinical use.

    Product
    Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Model/Catalog Number: HACF0533 Product Description: The HALO PKS Cutting Forceps are intended to be passed through a 5 mm laparoscopic cannula. Coagulation is achieved using electro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1629-2026·2026-04-01

    Orthalign drill plate sizes 1-5 may allow excessive bone cut

    Orthalign is recalling one lot of the Trimax Pegged Drill Plate sizes 1-5 for the Lantern Knee System because plates manufactured out of specification can result in a bone cut in excess of 0.0800 inches.

    Product
    Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0404-2026·2026-04-01

    Teva octreotide acetate 10 mg recalled over sterility assurance deficiencies

    Teva is recalling two lots of Octreotide Acetate for Injectable Suspension 10 mg after quality system deficiencies were identified during an FDA inspection at the contract manufacturer.

    Product
    OCTREOTIDE ACETATE — OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1601-2026·2026-04-01

    I.T.S. fibula and tubular plates heat more in MRI than stated

    I.T.S. GmbH is recalling the Fibula Plate PROlock with Angular Stability because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibul
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1598-2026·2026-04-01

    I.T.S. straight and forearm plates heat more in MRI than stated

    I.T.S. GmbH is recalling Straight Plates with Angular Stability, including forearm and compression plates, because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use reflected.

    Product
    I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Pla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1599-2026·2026-04-01

    I.T.S. cannulated screw system heats more in MRI than stated

    I.T.S. GmbH is recalling the I.T.S. Screw System because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.

    Product
    I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw, Cannulated; Article Numbers: 31404-16, 31404-18, 31404-20, 31404-22, 31404-24, 31404-26, 31404-28, 31404-30, 31404-32, 31404-34, 31404-36, 31404-38, 31404-40, 31404-42, 314
    Category
    Medical Device
    Distribution
    Distributed nationwide