The Recall Desk

State

Hawaii product recalls

73,092 recalls have nationwide distribution and so reach Hawaii. 2,770 additional recalls listed Hawaii specifically in their distribution scope.

What the numbers show

Total
2,770
Critical
333
Severe
569
Most recent
2026-09-23

Of the 2,770 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 569 (21%) are Severe.

Which agencies issued them

These figures cover only the 2,770 recalls whose distribution notice names Hawaii specifically. The 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8476–8500 of 75862

  • HighFDA (Devices)·Z-0746-2025·2025-01-01

    BD FACSLyric Flow Cytometer Power Supply May Fail During Use

    BD FACSLyric flow cytometers are recalled for power supply failures that may prevent the device from powering on, risking specimen loss and potential respiratory effects from fume inhalation.

    Product
    Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 00382906628763 The K170974 clearance document describes the device as follows: The BD FACSLyric" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical configurations) systems consist of a flow cy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0717-2025·2025-01-01

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Medline Industries recalls specific lots of surgical patties and strips in MAJOR NEURO PACK-LF Convenience kits due to higher-than-expected endotoxin levels detected in raw materials, which may have resulted in out-of-specification finished products.

    Product
    MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0769-2025·2025-01-01

    Hip Reconstruction System Component Mislabeled for Size

    Waldemar Link is recalling 3 units of the LINK MP Reconstruction System Neck Segment due to a labeling error indicating the wrong size (XXL instead of standard), though all other specifications on the labels are correct.

    Product
    LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadeq
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0729-2025·2025-01-01

    O&M Halyard Surgical Masks Recalled for Failing Bioburden Testing

    O&M Halyard SOFT TOUCH II Surgical Masks (lot AM4119961) are being recalled for not meeting EN 14683 bioburden testing standards printed on the packaging. No illnesses or injuries have been reported.

    Product
    O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0761-2025·2025-01-01

    EMPOWR 3D Knee Tibial Insert Recalled for Wrong Product in Package

    Encore Medical is recalling 9 units of EMPOWR 3D Knee Tibial Insert (Lot 076T1273A) because packages may contain an acetabular system instead of the intended knee insert, potentially causing surgical delays.

    Product
    EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0750-2025·2025-01-01

    BYTE Aligner System Recalled for Virtual-Only Approval Workflow Gaps

    Straight Smile LLC is recalling BYTE Aligner systems due to a virtual-only clinical workflow that may not adequately screen patients with contraindications for aligner use. Approximately 5.3 million devices are affected.

    Product
    BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V824000·2024-12-30

    Winnebago motorhome door windows can loosen and detach during transit

    Winnebago is recalling certain 2020-2024 View and Navion RVs with Lippert Metallarte door assemblies because incorrect window adhesion can cause the window to loosen or detach.

    Product
    WINNEBAGO — WINNEBAGO VIEW, NAVION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·25080·2024-12-26

    Inclusive Orbit merry-go-rounds recalled due to finger crush hazard

    About 415 Inclusive Orbit merry-go-rounds are recalled due to a crushing hazard where the gap between the rotating platform and outer rim narrows, trapping children's fingers. Two finger crushing injuries have been reported.

    Product
    Inclusive Orbit merry-go-rounds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·25078·2024-12-26

    Precor Resolute cable exercise equipment recalled for pulley drop hazard

    Precor recalls about 834 Resolute Cable exercise units; the pop-pin can fail, causing the pulley carriage to drop unexpectedly. The company received 9 reports of pulley drops, including 2 minor head injuries.

    Product
    Precor Resolute Cable Multi-Station Exercise Equipment
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25077·2024-12-26

    Avalanche Transceivers Recalled for Battery Contact Failure Risk

    Black Diamond recalls 770 PIEPS Pro IPS Avalanche Transceivers due to battery contact failure that could prevent operation during emergencies. Units were sold from February through November 2024 for $530–$620.

    Product
    PIEPS Pro IPS Avalanche Transceivers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25079·2024-12-26

    GIKPAL 12-Drawer Dressers Recalled for Tip-Over and Entrapment Hazards

    GIKPAL 12-Drawer Dressers are being recalled because they can tip over and trap children if not anchored to a wall. About 800 units were sold on Walmart.com; consumers should stop using them and contact ONME Direct for a refund.

    Product
    GIKPAL 12-Drawer Dressers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0655-2025·2024-12-25

    Kirwan Surgical Bipolar Pencil Recalled Due to Potential Tube Breakage

    Kirwan Surgical Products is recalling its Disposable 25-gauge Bipolar Pencil (Model 14-5011L) because the outer stainless-steel tube may break or detach during use. The defect could create a safety hazard during eye surgery and other soft tissue procedures.

    Product
    Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauteri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0661-2025·2024-12-25

    Medtronic Becker Neurosurgical Drainage Systems Recalled for Cracked and Leaking Stopcocks

    Medtronic Neurosurgery recalls Becker External Drainage and Monitoring Systems due to reports of cracks and leaks in stopcocks. The recalled systems are used to drain cerebrospinal fluid and monitor pressure in neurosurgery patients.

    Product
    Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 27670 BECKER 27670 STOP BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0654-2025·2024-12-25

    Kirwan Surgical Disposable Bipolar Pencils recalled for potential tube failure

    Kirwan Surgical Products is recalling 80,060 Disposable Bipolar Pencils (Model 14-5011) because the outer stainless-steel tube may break or detach during surgical use. The devices were distributed worldwide.

    Product
    Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0658-2025·2024-12-25

    Walcott Bipolar Pencil Surgical Instrument Recalled for Potential Tube Detachment

    Kirwan Surgical Products is recalling Walcott Bipolar Pencil 25 Gauge surgical instruments due to potential breakage or detachment of the stainless-steel tube. The affected pencils are used in eye and soft tissue surgery.

    Product
    Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0659-2025·2024-12-25

    Nidek Disposable Bipolar Pencil Surgical Instruments Recalled for Tube Breakage Risk

    Kirwan Surgical Products recalls Nidek Disposable Bipolar Pencil surgical instruments due to risk that the stainless-steel tube may break or detach during procedures.

    Product
    Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauteriza
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0291-2025·2024-12-25

    Whole Foods Organic Carrot Sticks Recalled for Potential E. coli Contamination

    Whole Foods Market Organic Carrot Sticks potentially contaminated with E. coli O121:H19 are being recalled. The recall affects 407 cases distributed in AZ, CA, HI, ID, and NV.

    Product
    WHOLE FOODS MARKET, Organic Carrot Sticks, NET WT. 15 oz (425 g), PERISHABLE KEEP REFRIGERATED, Packed For: Whole Foods Market Austin, TX 78703, Pre-washed and ready to eat
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0660-2025·2024-12-25

    Optikon Bipolar Pencil surgical tool recalled for tube failure risk

    FDA recalls Kirwan Surgical's Optikon Bipolar Pencil surgical instruments due to risk that the outer stainless-steel tube may break or detach during use. The recalled devices were distributed worldwide.

    Product
    Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0656-2025·2024-12-25

    Surgical Bipolar Pencil Recall: Risk of Tube Breakage During Eye Surgery

    Kirwan Surgical Products is recalling disposable bipolar surgical pencils used in eye surgery because the outer stainless-steel tube may break or detach during use.

    Product
    Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0662-2025·2024-12-25

    Exacta External Drainage System Stopcocks May Leak or Crack

    Medtronic Neurosurgery is recalling Exacta External Drainage and Monitoring Systems worldwide due to complaints of cracking and leaking stopcocks. These components control cerebrospinal fluid drainage and intracranial pressure monitoring.

    Product
    Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0151-2025·2024-12-25

    VCF Contraceptive Pre-filled Applicators Recalled for Out-of-Specification Active Ingredient

    Apothecus Pharmaceutical recalls 33,659 boxes of VCF nonoxynol-9 contraceptive gel nationwide due to out-of-specification active ingredient assay from manufacturing deviations. No illnesses reported.

    Product
    VCF CONTRACEPTIVE PRE-FILLED APPLICATORS — VCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0657-2025·2024-12-25

    Ambler Surgical Bipolar Pencil recalled for outer tube structural failure

    Kirwan Surgical Products is recalling the Ambler Surgical Bipolar Pencil 25 Gauge Straight (Model PD7226) because the outer stainless-steel tube may break or detach during use. 4,470 units worldwide are affected.

    Product
    Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area durin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0144-2025·2024-12-25

    Pearson Quality Topical Anesthetic Gel Recalled Due to Manufacturing Defect

    Keystone Industries is recalling Pearson Quality Topical Anesthetic Gel (20% Benzocaine) due to manufacturing equipment defects that could allow product contamination. The affected lot was inadvertently shipped despite quality control rejection.

    Product
    Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA.
    Category
    Drug
    Distribution
    Distributed nationwide