The Recall Desk

State

Hawaii product recalls

72,820 recalls have nationwide distribution and so reach Hawaii. 2,765 additional recalls listed Hawaii specifically in their distribution scope.

What the numbers show

Total
2,765
Critical
333
Severe
566
Most recent
2026-09-02

Of the 2,765 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 566 (20%) are Severe.

These figures cover only the 2,765 recalls whose distribution notice names Hawaii specifically. The 72,820 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

801–825 of 75585

  • HighFDA (Devices)·Z-2611-2026·2026-07-08

    Medline Convenience Kits with Recalled Swan-Ganz Catheters Nationwide

    Medline is recalling convenience kits containing Swan-Ganz catheters with a defective proximal injectate lumen hub that may leak, break, or cause infection and blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPEN HEART CDS QVH CDS982523M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2613-2026·2026-07-08

    Medline Convenience Kits with Recalled Swan-Ganz Catheters

    Medline Convenience kits containing Swan-Ganz catheters recalled by Becton Dickinson are being recalled due to leaks and breakage of the proximal injectate lumen hub, which may result in infection, medication loss, or blood loss.

    Product
    Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M CDS982269N CARDIAC MAJOR DYNJ901328D DYNJ901328F HEART A DYNJ903465F DYNJ903465G HEART TRAY-VASCULAR DYNJ907857 DYNJ907857A DYNJ90
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2665-2026·2026-07-08

    Groshong NXT ClearVue Catheter Recalled Due to Manufacturing Deficiency

    Bard Access Systems is recalling Groshong NXT ClearVue Catheters (4 Fr Single-Lumen) due to lidocaine ampoules manufactured under deficient practices. The product is distributed nationwide and internationally.

    Product
    7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong¿ NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2660-2026·2026-07-08

    Power-Trialysis Dialysis Catheters Recalled Due to Manufacturing Defects

    Bard Access Systems is recalling Power-Trialysis Short-Term Dialysis Catheters with triple-lumen design due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects approximately 8,795 units distributed nationwide and internationally.

    Product
    5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086953 5605240 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801741086977 5605300 Power-Trialysis Short-Term Straight Dialysis C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0698-2026·2026-07-08

    Fungal Fusion antifungal kit recalled for discontinued stability testing

    Blaine Labs Inc is recalling Fungal Fusion ERADICATION Solution kits nationwide because the manufacturer discontinued required stability testing for products still on the market within their expiration dates.

    Product
    Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2635-2026·2026-07-08

    CRE Wireguided Device Recall Due to Potential Sterile Packaging Breach

    Boston Scientific Corporation is recalling CRE Wireguided 12-15mm 240cm devices due to a potential sterile breach in the pouches containing the devices. The breach could compromise device sterility.

    Product
    CRE Wireguided 12-15mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2645-2026·2026-07-08

    Medela ENFit ExSet Enteral Extension Set Connector Compatibility Issue

    Medela ENFit ExSet Strl 60 enteral extension sets may contain incorrect connectors that do not attach or misconnect to ENFit connections, potentially delaying delivery of nutritional fluids or medication.

    Product
    Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit¿ Componen
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2663-2026·2026-07-08

    PowerMidline Catheter 4 Fr Dual-Lumen due to deficient manufacturing

    Bard Access Systems is recalling PowerMidline Catheter 4 Fr Dual-Lumen catheters because lidocaine ampoules were manufactured under deficient manufacturing practices.

    Product
    CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129278 P4254108D PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741129353 The PowerMidline" Catheter is intended
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2537-2026·2026-07-08

    Medline Convenience Kits with Lidocaine Ampules Recalled for Quality Issues

    Medline Industries is recalling three convenience kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing inspection of Huons' facility.

    Product
    Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A, Model Number: CONT. 20G EPI MRI COMPATIBLE; 3) TVS4000L, Model Number: TVS4000 ENDOVENOUS PACK
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2534-2026·2026-07-08

    Medline Convenience Kits with Lidocaine Ampules Recalled for Quality Issues

    Medline Industries is recalling 1,512 Convenience Kits nationwide that contain Lidocaine HCL Injection USP ampules due to quality issues identified during an FDA manufacturing inspection of the supplier's facility.

    Product
    Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1317; 3) CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1579A; 4) CSE TRAY, Model Number: PAIN1885A; 5) REINFORCED CATH EPIDURAL TRAY, Model Number: P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2661-2026·2026-07-08

    Power-Trialysis Slim-Cath Dialysis Catheters Recalled by Bard Access Systems

    Bard Access Systems is recalling Power-Trialysis Slim-Cath short-term dialysis catheters due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects multiple product models distributed nationwide and internationally.

    Product
    5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 5865120 Power-Trialysis Slim-Cath
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2533-2026·2026-07-08

    Medline arterial access and insertion kits with lidocaine ampules recalled

    Medline Industries is recalling three arterial access and insertion kits nationwide because they contain lidocaine ampules subject to a quality issue recall by the manufacturer Huons Co., Ltd., identified during an FDA manufacturing inspection.

    Product
    Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universal Central/Art Line Insertion Kit, Model Number: ART155A; 3) ARTERIAL LINE INSERTION TRAY, Model Number: ART1010B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2648-2026·2026-07-08

    ARTIS icono ceiling medical imaging monitor suspension system

    Siemens Medical Solutions is recalling ARTIS icono ceiling Model 11328100 because screws in the Display ceiling suspension (DCS Fix XL) that hold the monitor may gradually loosen over time, potentially causing the monitor to detach.

    Product
    ARTIS icono ceiling. Model Number: 11328100.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2649-2026·2026-07-08

    Zeiss Intrabeam Spherical Applicator failed manufacturing specifications

    Carl Zeiss Meditec AG is recalling Zeiss Intrabeam Spherical Applicator 1.5 cm units because they failed to meet manufacturing specifications.

    Product
    Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2535-2026·2026-07-08

    Medline Convenience Kits Block Tray recalled due to quality defects

    Medline Industries is recalling Convenience Kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules due to quality issues identified during an FDA manufacturing inspection of the supplier's facility.

    Product
    Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2658-2026·2026-07-08

    PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen Medical Device Recall

    Bard Access Systems, Inc. is recalling PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen devices due to lidocaine ampoules manufactured under deficient manufacturing practices by the supplier.

    Product
    CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2538-2026·2026-07-08

    Medline Convenience Kits with Lidocaine Ampules Recalled for Quality Issues

    Medline Industries is recalling Medline Convenience Kits containing Huons Lidocaine HCL Injection USP 1% due to quality issues identified during an FDA manufacturing inspection.

    Product
    Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, INTRO-FLEX INTRODUCER 9F, C, Model Number: I505BF9C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2636-2026·2026-07-08

    CRE Wireguided 15-18mm 240cm Medical Device Sterile Pouch Breach

    Boston Scientific Corporation is recalling the CRE Wireguided 15-18mm 240cm device due to a potential sterile breach in the packaging pouches. The affected devices were distributed worldwide.

    Product
    CRE Wireguided 15-18mm 240cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2664-2026·2026-07-08

    PowerPICC Provena Catheters recalled for deficient manufacturing practices

    Bard Access Systems is recalling PowerPICC Provena Catheters due to lidocaine ampoules manufactured under deficient manufacturing practices. The recall affects 29,490 units distributed nationwide and in Belgium.

    Product
    CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188800 CK000884A PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741219177 CK001000 PowerPI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2667-2026·2026-07-08

    Provena Midline Catheters recalled due to deficient manufacturing practices

    Bard Access Systems is recalling Provena Midline Catheters because lidocaine ampoules used in manufacturing were produced under deficient manufacturing practices by a supplier.

    Product
    CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154003 S4153108BP Provena Midline Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741153990 S4153108D Provena Midline
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2544-2026·2026-07-08

    Medline Lumbar Puncture Kit recalled for Lidocaine quality issues

    Medline Convenience Kits containing Huons Lidocaine HCL Injection USP 1% ampules are being recalled due to quality issues identified during an FDA manufacturing inspection. Affected kits have been distributed nationwide.

    Product
    Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0695-2026·2026-07-08

    TERPENICOL Antifungal Cream Recalled for CGMP Deviations

    Blaine Labs Inc is recalling TERPENICOL Antifungal Cream due to CGMP deviations: the firm discontinued required stability testing for products still within expiry dates. The recall affects 22,143 bottles distributed nationwide.

    Product
    TERPENICOL — TERPENICOL (UNDECYLENIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2655-2026·2026-07-08

    Thoracentesis and Paracentesis Trays Recalled for Deficient Manufacturing

    Bard Access Systems, Inc. is recalling three models of thoracentesis and paracentesis trays due to lidocaine ampoules being manufactured under deficient manufacturing practices. The devices are used for fluid removal procedures and have been distributed nationwide and in Belgium.

    Product
    OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 The Acute Drainage devices are indicated for use in re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2671-2026·2026-07-08

    Radius VSM Disposable NIBP Cuff recalled for rough edges

    Masimo Corporation is recalling Radius VSM Disposable NIBP Cuffs (blood pressure cuffs) with lot numbers 21G6S through 25ADF because they may contain rough edges that could cause skin irritation or redness.

    Product
    Radius VSM Disposable NIBP Cuff, REF: 4825, 4826
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2674-2026·2026-07-08

    Sterile Tourniquet Hoses recalled for potential sterility breach

    Zimmer Surgical Inc is recalling A.T.S 4000 TS Tourniquet Systems Single Hose units due to a potential sterility breach in the sealing area of the sterile pouch. If used, the compromised sterility may result in moderate localized infection.

    Product
    Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide