State

Hawaii product recalls

72,907 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.

Which agencies issued them

These figures cover only the 2,766 recalls whose distribution notice names Hawaii specifically. The 72,907 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

901–925 of 75673

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-2536-2026·2026-07-08
Medline Lidocaine HCL Injection Ampules Recalled for Quality Issues
Medline Industries is recalling convenience kits containing Huons Lidocaine HCL Injection USP 1% ampules due to quality issues identified during an FDA manufacturing inspection of the drug maker's site.
Product
Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 2) TRIPLE LUMEN CENTRAL LINE BUNDLE, Model Number: ECVC2625; 3) INTROFLEX 6F, 1L, TB, US, Model Number: STCVC26US; 4) AVA HIGH FLOW, Model Number: ECVC3720; 5) CDP, MM, 3L, 7F, 16CM
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2542-2026·2026-07-08
Medline Convenience Kits recalled for defective Lidocaine Ampules
Medline Industries is recalling 15,662 Convenience Kits containing Huons Lidocaine HCL Injection USP due to quality issues identified during an FDA manufacturing inspection of the drug supplier's facility.
Product
Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, Model Number: MNS3390; 3) CONTRACEPTIVE IMPLANT INSERTION KIT, Model Number: MNS9715; 4) 20GX3" RADIAL ART LINE KIT, Model Number: ART351; 5) MYELOGRAM PACK, Model Number: P15
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2630-2026·2026-07-08
CRE Pro Wireguided Medical Device Recall for Sterile Packaging Breach
Boston Scientific is recalling the CRE Pro Wireguided 15-18mm 240cm device due to a potential sterile breach of the product pouches. The breach may compromise device sterility.
Product
CRE Pro Wireguided 15-18mm 240cm
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2657-2026·2026-07-08
DuoGlide Short-Term Dialysis Catheter recall due to deficient manufacturing
Bard Access Systems is recalling lidocaine ampoules used with DuoGlide Short-Term Dialysis Catheters due to deficient manufacturing practices by the supplier. The catheters are used for temporary vascular access for hemodialysis.
Product
5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, or apheresis thera
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2659-2026·2026-07-08
PowerPICC SV Catheters recalled due to deficient lidocaine manufacturing
Bard Access Systems is recalling PowerPICC SV Catheters because lidocaine ampoules supplied with the product were manufactured under deficient practices.
Product
1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536 The PowerPlCC SV catheters are intended for short or long term peripheral access to the central venous system for intravenous th
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2653-2026·2026-07-08
Covidien Shiley Disposable Decannulation Plug product labeling error
Covidien LLC is recalling Shiley Disposable Decannulation Plug devices because the product labeling incorrectly indicates the product does not contain DEHP, when in fact the product contains 30 to 35% DEHP.
Product
Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS 10884522006583 4DFEN 10884522006606 6DCFN 10884
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-2540-2026·2026-07-08
Medline Suturing Set with Lidocaine Ampules Recalled
Medline Convenience Kits (Suturing Set, Model SUT13710) containing Huons Lidocaine HCL Injection USP are being recalled due to quality issues identified during an FDA manufacturing inspection.
Product
Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2641-2026·2026-07-08
ARTIS icono biplane medical imaging system detector lift malfunction
Siemens is recalling 85 units of the ARTIS icono biplane (Model 11327600) due to potential loss of detector movement capability when adjusted to maximum or minimum lift height limits.
Product
ARTIS icono biplane. Model Number: 11327600.
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-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-2546-2026·2026-07-08
Medline Circumcision Trays recalled due to Lidocaine quality issues
Medline Industries is recalling three models of circumcision trays containing Lidocaine ampules due to quality issues identified during an FDA inspection of the drug manufacturer.
Product
Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2) CIRCUMCISION TRAY W/1.1CM CIRCLAMP, Model Number: CIT3225A; 3) CIRCUMCISION TRAY, Model Number: CIT6325
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-2547-2026·2026-07-08
Medline Ophthalmic Pack with Lidocaine Injection Kits Recalled
Medline is recalling Ophthalmic Pack convenience kits containing Huons Lidocaine HCL Injection due to quality issues identified during an FDA manufacturing inspection. The recall affects 180 kits distributed nationwide.
Product
Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2666-2026·2026-07-08
PowerPICC Catheters recalled for deficient manufacturing practices
Bard Access Systems, Inc. is recalling multiple PowerPICC catheter models due to lidocaine ampoules being manufactured under deficient manufacturing practices by the supplier.
Product
1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034602 1174108D3 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1174108D4 PowerPICC Catheter 4 Fr Single-Lum
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2673-2026·2026-07-08
Sterile Tourniquet Hoses Recalled Due to Potential Sterility Breach
Zimmer Surgical Inc is recalling A.T.S. 4000 TS Tourniquet Systems Dual Hose with CPC Connectors due to a potential sterility breach in the sealing area of the sterile pouch. If used, the issue may result in moderate localized infection.
Product
Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A
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-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-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 (Devices)·Z-2662-2026·2026-07-08
PowerMidline Catheters Recalled for Deficient Manufacturing Practices
Bard Access Systems is recalling PowerMidline Catheters due to lidocaine ampoules being manufactured under deficient manufacturing practices. The catheters are used for short-term peripheral intravenous access and have been distributed nationwide and internationally.
Product
CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138713 P4153108D PowerMidline Catheter 3 Fr Single-lumen UDI-DI Code: 00801741108747 P4154108 PowerMidline Catheter 4 Fr
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-2539-2026·2026-07-08
Medline Convenience Kits with Lidocaine Ampules Recalled for Quality Issues
Medline Industries is recalling Imaging Biopsy Tray and Breast Biopsy Pack kits containing Huons Lidocaine HCL Injection USP due to quality issues identified during an FDA manufacturing inspection.
Product
Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, Model Number: PHS234706I
Category
Medical Device
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-2633-2026·2026-07-08
CRE Wireguided 8-10mm 240cm Medical Device Recall Notice
Boston Scientific Corporation is recalling CRE Wireguided 8-10mm 240cm devices worldwide due to potential sterile breaches in the packaging pouches that could compromise device sterility.
Product
CRE Wireguided 8-10mm 240cm
Category
Medical Device
Distribution
Distributed nationwide