The Recall Desk

State

Hawaii product recalls

73,576 recalls have nationwide distribution and so reach Hawaii. 2,772 additional recalls listed Hawaii specifically in their distribution scope.

What the numbers show

Total
2,772
Critical
333
Severe
715
Most recent
2026-10-14

Of the 2,772 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 715 (26%) are Severe.

Which agencies issued them

These figures cover only the 2,772 recalls whose distribution notice names Hawaii specifically. The 73,576 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

426–450 of 76348

  • HighFDA (Devices)·Z-3215-2026·2026-09-30

    Heidelberg SPECTRALIS Flex Module Recall Due to Wheel Detachment Risk

    Heidelberg Engineering is recalling 87 SPECTRALIS units with Flex Modules because wheels may detach, causing the stand to tip over and injure nearby people.

    Product
    Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610, S2610, S2000, S1610 multimodal imaging platform optimized for the posterior segment of the eye
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3224-2026·2026-09-30

    Maquet PowerLED 300 Concealed Lighting System Recalled for Detachment Risk

    Maquet is recalling 667 PowerLED 300 Concealed Lighting Systems because the spring arm may detach and fall, posing a potential injury risk.

    Product
    PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3251-2026·2026-09-30

    Abiomed Recalls Automated Impella Controllers Due to Firmware and Software Defects

    Abiomed is recalling 3,322 Automated Impella Controllers worldwide due to firmware and software defects that affect pressure signal accuracy and system reliability.

    Product
    Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3230-2026·2026-09-30

    Medline Instrument Channel Brush Kits Recalled for Sharp Edges

    Medline is recalling Healthmark Instrument Channel Brush kits due to potential sharp edges that could cause cuts, abrasions, or infection.

    Product
    Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ48258D and SINUS PACK DYNJ48258F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3219-2026·2026-09-30

    Midmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings

    Midmark Corporation is recalling 20 IQvitals Zone units because a performance issue may cause inaccurate blood pressure readings when using the Linear Deflation Method.

    Product
    Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0350 with Kit Number: 4-000-0722
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3268-2026·2026-09-30

    Medline Neurological Surgery Kits Recalled for Endotoxin Variability

    Medline is recalling 234 neurological surgery kits nationwide due to potential endotoxin variability that may cause adverse health reactions.

    Product
    Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I; 2) NEURO PACK-LF, Catalog Number: DYNJ41246F; 3) CRANIOTOMY PACK (CRSJE)227-LF, Catalog Number: DYNJ47487A; 4) MAJOR NEURO PACK, Catalog Number: DYNJ57233J; 5) NEURO, Catalog Number: DYNJ82388A…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3220-2026·2026-09-30

    Midmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings

    Midmark Corporation is recalling 33 IQvitals Zone units because a performance issue may cause inaccurate blood pressure readings when using the Linear Deflation Method.

    Product
    Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0360 with Kit Number: 4-000-0724
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3259-2026·2026-09-30

    New York Embroidery Studio Recalls Isolation Gowns for Liquid Barrier Failure

    New York Embroidery Studio is recalling 5,400 Trinity Non-Surgical Isolation Gowns because they do not consistently meet minimum liquid-barrier performance requirements.

    Product
    New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs of 10 and 100 gowns per shipping case.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3254-2026·2026-09-30

    Cardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects

    Cardinal Health is recalling 17,503 Presource Convenience Kits because applicator packaging may have open or incomplete seals, posing a risk of infection.

    Product
    Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3) KIT, PRE PROCEDURE , Catalog Number: IVSJV8302E; 4) KIT, IV SUPPLIES , Catalog Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3246-2026·2026-09-30

    Olympus BiCOAG Hemostasis Probe Recalled for Ceramic Tip Detachment Risk

    Olympus is recalling 2,142 BiCOAG Hemostasis Probes because a manufacturing error may cause the ceramic tip to detach.

    Product
    Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V629000·2026-09-30

    Greenpower Recalls EV Star Buses Due to Software Error

    Greenpower is recalling 94 EV Star buses because a software error may allow the vehicle to move while the wheelchair lift is deployed.

    Product
    GREENPOWER — GREENPOWER EV STAR MOBILITY PLUS BUS, EV STAR BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3218-2026·2026-09-30

    Midmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings

    Midmark Corporation is recalling 153 IQvitals Zone units because a performance issue may cause inaccurate blood pressure readings when using the Linear Deflation Method.

    Product
    Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-03300 with Kit Number: 4-000-0624
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3226-2026·2026-09-30

    SeaSpine Mariner Deformity Spinal Device Recall Due to Thread Depth Issue

    SeaSpine Orthopedics is recalling 270 units of the Mariner Deformity Extended Polyaxial Head because the proximal thread depth is out of design specification.

    Product
    SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3258-2026·2026-09-30

    Intervascular Recalls Cardioroot Woven Collagen Coated Vascular Grafts

    Intervascular is recalling Cardioroot Woven Collagen Coated Vascular Grafts because the product failed to meet acceptance criteria for Integral Water Permeability.

    Product
    Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3267-2026·2026-09-30

    Medline Craniotomy Kits Recalled for Potential Endotoxin Variability

    Medline is recalling 486 craniotomy convenience kits due to potential endotoxin variability that may cause adverse health reactions.

    Product
    Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348R; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348S; 5) SLUH CRANIOTOMY…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3217-2026·2026-09-30

    Midmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings

    Midmark Corporation is recalling IQvitals Zone devices because a performance issue may cause inaccurate blood pressure readings when using the Linear Deflation Method.

    Product
    Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blood pressure, pulse rate, temperature (temporal), and oxygen saturation (SpO2) for adult and pediatric patients, Model Number: 1-200-0320 with Kit Number: 4-000-0622
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3265-2026·2026-09-30

    Medline Neurological Sponges Recalled for Potential Endotoxin Variability

    Medline is recalling 695 convenience kits containing neurological sponges due to potential endotoxin variability that may cause adverse health reactions.

    Product
    Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ0342705J; 3) NASAL-LF, Catalog Number: DYNJ40094G; 4) ENT PACK, Catalog Number: DYNJ50699F; 5) EENT PACK, Catalog Number: DYNJ83219
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3269-2026·2026-09-30

    Medline Neurological Surgery Kits Recalled for Endotoxin Variability

    Medline Industries is recalling 4,013 neurological surgery kits due to potential endotoxin variability that may cause adverse health reactions.

    Product
    Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001; 3) CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348O; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348P; 5) LAMINECTOMY PACK-LF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3255-2026·2026-09-30

    Cardinal Health Recalls Presource Convenience Kits Due to Seal Defects

    Cardinal Health 200, LLC is recalling Presource Convenience Kits because applicator packaging may have open or incomplete seals, posing a risk of infection.

    Product
    Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V626000·2026-09-30

    Starcraft Super Lite Maxx Travel Trailer Recall for Water Tank Fasteners

    Starcraft RV is recalling 2022-2024 Super Lite Maxx travel trailers because fasteners may fail, causing the fresh water tank to detach and create a road hazard.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT SUPER LITE MAXX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3232-2026·2026-09-30

    Philips Achieva 1.5T MRI Systems Recalled for Software Memory Issue

    Philips is recalling 387 Achieva 1.5T MRI systems worldwide because a software issue may terminate examinations if manual scan adjustments exceed system memory.

    Product
    Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva 1.5 Conversion), 5. 781178 (Achieva 1.5T Initial System);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3223-2026·2026-09-30

    Ventec HomeFill Oxygen System Recalled for Missing Medical Gas Labeling

    Ventec Life Systems is recalling 25 HomeFill Oxygen Systems because the cylinders lack required medical gas labeling.

    Product
    REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3264-2026·2026-09-30

    Baxter PRO+ Mattress Recalled for UDI Labeling Error

    Baxter Healthcare is recalling six PRO+ 40-inch MRS Surface mattresses due to errors in the Unique Device Identification (UDI) label text.

    Product
    PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P7924A14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3253-2026·2026-09-30

    Criticare nGenuity Patient Monitor Recalled for Capnography Setup Error

    Criticare Technologies is recalling 1,007 nGenuity Patient Monitors because a setup error renders the CO2 monitoring function inoperable, potentially delaying procedures.

    Product
    nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1R
    Category
    Medical Device
    Distribution
    Distributed nationwide