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.

Which agencies issued them

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.

751–775 of 75585

SevereFDA (Devices)·Z-2548-2026·2026-07-08
Hillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk
Baxter Healthcare is recalling the Hillrom VOLARA System P.CIRCUIT KIT (Model REF M08085) due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and reduce treatment effectiveness.
Product
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2610-2026·2026-07-08
Medline Convenience Kits with Recalled Swan-Ganz Catheters
Medline Convenience kits containing Swan-Ganz catheters are being recalled due to leaks and breakage of the proximal injectate lumen hub, which may lead to infection, medication loss, and blood loss.
Product
Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP DYNJ905503D DYNJ905503F DYNJ905503G
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2603-2026·2026-07-08
Omnipod 5 Insulin Infusion Pods Recalled for External Cannula Damage
Insulet Corporation is recalling approximately 4.9 million Omnipod 5 insulin pods due to external soft cannula damage during manufacturing that can cause insulin leakage and under-delivery, potentially leading to high blood glucose and serious diabetic complications.
Product
Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6720. 6. BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0723-2026·2026-07-08
Glucagon Emergency Kit Recalled for Manufacturing Process Deviation
Lupin Pharmaceuticals is recalling Glucagon Emergency Kits (1mg) nationwide due to a manufacturing process deviation found during stability testing. The gliding force functionality test failed to meet specifications during 12-month testing.
Product
GLUCAGON — GLUCAGON (GLUCAGON)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0658-2026·2026-07-08
Accucaine Lidocaine Injection Recalled for Lack of Sterility Assurance
Asclemed USA Inc. is recalling specific lots of Accucaine (Lidocaine HCl Injection USP, 1%) distributed nationwide due to lack of assurance of sterility. The affected product is distributed by Enovachem Pharmaceuticals.
Product
ACCUCAINE — ACCUCAINE (LIDOCAINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0648-2026·2026-07-08
ChloraPrep One-Step Antiseptic Applicators recalled for lack of sterility assurance
CareFusion is recalling ChloraPrep One-Step antiseptic applicators because unsterilized units intended for further processing were distributed outside the intended channel, creating a sterility assurance gap.
Product
CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·H-1137-2026·2026-07-08
NARA ORGANICS Whole Milk Organic Infant Formula Recalled for Botulinum Contamination
NARA ORGANICS Whole Milk Organic Infant Formula in 24.7 oz and 14.1 oz sizes is being recalled nationwide because the product may be contaminated with Clostridium botulinum.
Product
a.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 24.7 OZ (700 G); UPC: 860013251901 b.) nara organics brand; Whole Milk Organic Infant Formula; Milk-based Powder with Iron; 0-12 months; NET WT 14.1 OZ (400 G); UPC: 8600
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2620-2026·2026-07-08
Thyroid FNA Pack-RX Surgical Kit Recalled for Bacterial Contamination
Windstone Medical Packaging is recalling AMS Thyroid FNA Pack-RX surgical kits due to contamination with Paenibacillus phoenicis bacteria found in included Webcol alcohol prep pads.
Product
A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2624-2026·2026-07-08
Medtronic Harmony Delivery Catheter System Distal Tip Detachment Risk
Medtronic is recalling certain lots of the Harmony Delivery Catheter System due to a manufacturing issue that may cause the distal tip to detach from the delivery system during procedures.
Product
Medtronic Harmony Delivery Catheter System
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2644-2026·2026-07-08
Cyberknife Treatment Delivery System Collimator Docking and Fall Hazard Recall
Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems with the Xchange Robotic Collimator Changer because a collimator may fail to fully dock and fall from the housing if room-control pendant motion is initiated while the system interlock is bypassed.
Product
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0676-2026·2026-07-08
Cinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
Cipla USA, Inc. is recalling Cinacalcet Hydrochloride 90 mg tablets (Lot #5PB0563, expiring 4/30/2027) distributed nationwide due to the presence of N-nitroso-cinacalcet above acceptable daily intake levels, a manufacturing deviation.
Product
CINACALCET — CINACALCET (CINACALCET)
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·26V441000·2026-07-08
BMW Recalls 29,119 Vehicles Due to Starter Relay Fire Risk
BMW is recalling 29,119 vehicles because a corroded starter relay may overheat and short circuit, increasing the risk of a fire.
Product
BMW — BMW 530E XDRIVE IPERFORMANCE, 740LE XDRIVE IPERFORMANCE, 530E IPERFORMANCE, 330E IPERFORMANCE
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2607-2026·2026-07-08
Medline Convenience Kits with Swan-Ganz Catheters Recalled for Defects
Medline is recalling convenience kits containing Swan-Ganz catheters due to failures of the proximal injectate lumen hub that can cause leaks, lumen damage, and breakage, potentially resulting in infection, medication loss, or blood loss.
Product
Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G HEART A DYNJ903465K OPEN HEART DYNJ909090G SILVER CROSS OPEN HEART DYNJ906102M VPH OPEN HEART DYNJ902664M DYNJ902664N
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2640-2026·2026-07-08
Cyberknife Treatment Delivery System Collimator Docking Failure Risk
Accuray Incorporated is recalling Cyberknife Treatment Delivery Systems equipped with the Xchange Robotic Collimator Changer due to a risk that the collimator may not fully dock and could fall from the housing if the in-room control pendant is used.
Product
Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2551-2026·2026-07-08
Hillrom VOLARA System patient circuits recalled for nebulizer cup leakage
Baxter Healthcare is recalling Hillrom VOLARA System patient circuits due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and ineffective medication delivery.
Product
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·26V438000·2026-07-08
BMW and Toyota vehicles recalled due to engine starter fire risk
BMW of North America, LLC is recalling various BMW and Toyota Supra models because the engine starter may overheat and catch fire.
Product
TOYOTA — TOYOTA, BMW SUPRA, Z4, X4, X3
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2615-2026·2026-07-08
Reprocessed Electrophysiology Catheters Recalled for Residual Particles
Medline Industries is recalling reprocessed electrophysiology and ultrasound catheters with residual particles that may cause inflammation, infection, or blood clots if contacted with blood or the heart.
Product
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2463-2026·2026-07-08
Ventilator breathing circuit sets may obstruct exhalation valve
Hamilton Medical AG is recalling coaxial breathing circuit sets used with three ventilator models because membranes may stick to the expiratory valve body, preventing proper gas exhalation and potentially causing inadequate ventilation.
Product
Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2634-2026·2026-07-08
Boston Scientific CRE Wireguided Medical Device Recall Sterile Breach
Boston Scientific is recalling CRE Wireguided 10-12mm 240cm medical devices due to a potential sterile breach in the product packaging. The breach could compromise device sterility and affect patient safety.
Product
CRE Wireguided 10-12mm 240cm
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0653-2026·2026-07-08
IMULDOSA injection recalled due to lack of sterility assurance
Accord BioPharma is recalling IMULDOSA (ustekinumab-srlf) Injection due to lack of assurance of sterility. The affected lot was distributed nationwide.
Product
IMULDOSA — IMULDOSA (USTEKINUMAB-SRLF)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0675-2026·2026-07-08
Cinacalcet Tablets Recalled for cGMP Deviations
Cipla USA, Inc. is recalling Cinacalcet Hydrochloride Tablets, 60 mg due to cGMP deviations involving the presence of N-nitroso-cinacalcet above acceptable daily intake levels.
Product
CINACALCET — CINACALCET (CINACALCET)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0645-2026·2026-07-08
ChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
CareFusion 213, LLC is recalling ChloraPrep One-Step applicators nationwide because unsterilized units intended for further processing were distributed to customers outside the intended distribution channel, lacking sterility assurance.
Product
CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0659-2026·2026-07-08
Lidocaine Hydrochloride Injection Recalled for Sterility Assurance
Asclemed USA Inc. is recalling Lidocaine Hydrochloride Injection USP, 1% (10 mg/mL) in 5 mL single dose ampules nationwide due to lack of assurance of sterility. The affected lots have expiration dates of 11/30/2026 and 04/30/2028.
Product
LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE ANHYDROUS)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0655-2026·2026-07-08
Prednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
Lupin Pharmaceuticals is recalling Prednisolone Acetate Ophthalmic Suspension, USP, 1% due to the presence of a foreign substance. Affected lot numbers were distributed nationwide.
Product
PREDNISOLONE ACETATE — PREDNISOLONE ACETATE (PREDNISOLONE ACETATE)
Category
Drug
Distribution
Distributed nationwide
HighNHTSA·26V443000·2026-07-08
Husqvarna and GasGas Motorcycles Recalled for Brake Caliper Cracks
KTM North America is recalling certain 2022-2024 Husqvarna FE 501S, FE 350S, and 2024 GasGas ES 350 and ES 500 motorcycles due to a potential rear brake caliper crack that could reduce braking ability and increase crash risk.
Product
HUSQVARNA — HUSQVARNA, GASGAS FE 501S, ES 500, ES 350, FE 350S
Category
Vehicle
Distribution
Distributed nationwide