State

Hawaii product recalls

72,982 recalls have nationwide distribution and so reach Hawaii. 2,767 additional recalls listed Hawaii specifically in their distribution scope.

What the numbers show

Total: 2,767
Critical: 333
Severe: 567
Most recent: 2026-09-16

Of the 2,767 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 2,767 recalls whose distribution notice names Hawaii specifically. The 72,982 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5676–5700 of 75749

SevereFDA (Devices)·Z-2291-2025·2025-08-20
HeartMate mobile power unit cords may disconnect from a misaligned lock
HeartMate Mobile Power Units are being recalled because misaligned V-Lock features on the power cords prevent the locking mechanism engaging properly and may cause unintended disconnect. 604 units affected.
Product
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2322-2025·2025-08-20
Thyroglobulin assay reagent recalled after lot generated erroneously high patient results
Access Thyroglobulin assay reagent lot 439163 is recalled because it may generate erroneously high patient results, which could prompt unnecessary imaging or therapy changes. 453 units are affected.
Product
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2278-2025·2025-08-20
FARAWAVE ablation catheters may have cracks in the distal electrode bands
FARAWAVE 1.0 Pulsed Field Ablation Catheters are being recalled because specific manufacturing equipment may have caused cracks in the electrode bands on the catheter's distal end. 445 units affected.
Product
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0579-2025·2025-08-20
Glenmark carvedilol 25 mg tablets exceed the acceptable nitrosamine intake level
Carvedilol Tablets USP 25 mg from Glenmark are being recalled because of the presence of a nitrosamine, N-Nitroso Carvedilol I, above the current Acceptable Intake Level. 4,800 bottles affected.
Product
CARVEDILOL — CARVEDILOL (CARVEDILOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·H-0468-2025·2025-08-20
Mini variety paletas recalled because label lists cream without declaring milk
Helados Mexico Minis Variety Paletas, 12-count 18 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 643,519 units are affected.
Product
Helados Mexico Minis Variety Paletas 12-Count 18oz UPC: 6-82082-11215-6
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0460-2025·2025-08-20
Mango con crema paletas recalled for listing cream without milk allergen declaration
La Michoacana Mango Con Crema Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 24,228 units are affected.
Product
La Michoacana Mango Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00008-2
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0449-2025·2025-08-20
Sukhi's classic curry paste may contain metal foreign objects
Sukhi's Classic Curry Paste in 2.5 lb packs is being recalled because of potential contamination with foreign objects, specifically metal pieces. 5,030 pounds are affected.
Product
Sukhi's CLASSIC CURRY PASTE, Net Wt. 2.5 LBS, ITEM # 11-101, UPC: 7-67226-01001-4, SUKHI'S GOURMET INDIAN FOODS HAYWARD, CA 94545
Category
Food
Distribution
33 states
HighFDA (Devices)·Z-2286-2025·2025-08-20
EMPOWR 3D knee tibial inserts recalled over incorrect size or side labeling
Enovis is recalling 40 EMPOWR 3D Knee tibial inserts, catalog number 342-16-707, because the implants carry incorrect size or side labeling.
Product
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0586-2025·2025-08-20
Sodium chloride injection containers recalled over potential fluid leakage at weld site
B. Braun 0.9% Sodium Chloride Injection USP, 1000 mL Excel containers, lot J5C919, is recalled for lack of assurance of sterility because of potential fluid leakage at a weld site. 23,100 containers are affected.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·H-0450-2025·2025-08-20
Sukhi's tikka masala curry paste may contain metal foreign objects
Sukhi's Tikka Masala Curry Paste in 2.5 lb packs is being recalled because of potential contamination with foreign objects, specifically metal pieces. 9,930 pounds are affected.
Product
Sukhi's TIKKA MASALA CURRY PASTE, Net Wt. 2.5 LBS, ITEM # 11-105, UPC 7-67226-01005-2, SUKHI'S GOURMET INDIAN FOODS HAYWARD, CA 94545
Category
Food
Distribution
33 states
HighFDA (Food)·H-0465-2025·2025-08-20
La Michoacana variety paletas list cream without declaring milk as source
La Michoacana Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 29,180 units are affected.
Product
La Michoacana Minis Variety Paletas 12-Count 16.5oz UPC: 7-67778-03042-3
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2287-2025·2025-08-20
Neurostimulator patient controllers recalled over cable disconnect errors interrupting stimulation output
Sparrow Ascent Patient Controllers are recalled because a manufacturing issue may produce a cable disconnect error message and interrupt stimulation output. 78 units are affected.
Product
Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0425-2025·2025-08-20
Dessert dip recalled nationwide after plastic foreign material found in product
Park Street Deli Cinnamon Bun Dessert Dip in 7 oz plastic tubs is recalled nationwide for plastic foreign material. 19,368 retail units are affected.
Product
Park Street Deli Cinnamon Bun Dessert Dip Net WT 7oz. in plastic tub UPC 4061462440151
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0587-2025·2025-08-20
Glenmark carvedilol 12.5 mg tablets exceed the nitrosamine impurity limit
Carvedilol Tablets USP 12.5 mg from Glenmark are being recalled because N-Nitroso Carvedilol Impurity-1 was observed above the FDA-recommended limit of not more than 4.0 ppm. 17,496 bottles affected.
Product
CARVEDILOL — CARVEDILOL (CARVEDILOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2295-2025·2025-08-20
Custom manifold kit tubing may separate and trap air in line
Custom Manifold Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 6,327 units affected.
Product
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2297-2025·2025-08-20
3mensio workstation clock measurements may place stent graft fenestrations incorrectly
3mensio Workstation (Vascular Fenestrated) software is being recalled because changing the 12h position of a single clock does not update other clock measurements, which may place stent graft fenestrations incorrectly. 501 units affected.
Product
3mensio Workstation (Vascular Fenestrated) software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2284-2025·2025-08-20
Kittner roll gauze with tail recalled over contamination and incorrect pack quantity
Carefree Surgical Specialties Kittner Roll Gauze + Tail, catalog 15506/25 lot 1607, is recalled for biological foreign matter that could compromise sterility and for incorrect gauze counts. 65 units are affected.
Product
Brand Name: Carefree Surgical Specialties Product Name: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray Detectable 5pk 25pk/CS Roll Gauzes Model/Catalog Number: 15506/25 Product Description: Robotic/Laparoscopy Kittner Roll Gauze + Tail Medium 4 Long X-Ray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2294-2025·2025-08-20
Custom tubing kits recalled because high pressure tubing may trap air
Custom Tubing Kits under REF K04-00417, K04-00963 and K04-01029 are recalled because high pressure tubing may separate from its connector and trap air that could reach the patient. 2,779 units are affected.
Product
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0463-2025·2025-08-20
Coconut con crema 6-pack paletas recalled over undeclared milk in cream
La Michoacana Coconut Con Crema 6-Pack Paletas, 16.5 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 47,065 units are affected.
Product
La Michoacana Coconut Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00101-0
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0470-2025·2025-08-20
Helados Mexico choco dipped paletas list cream without declaring milk
Helados Mexico Choco Dipped Minis Variety Paletas 12-count are being recalled because the label includes the ingredient cream but does not include milk as the source. 70,044 units affected.
Product
Helados Mexico Choco Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-41215-7
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0458-2025·2025-08-20
Single serve coconut con crema paletas recalled for missing milk source declaration
La Michoacana Coconut Con Crema Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 74,654 units are affected.
Product
La Michoacana Coconut Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00001-3
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2285-2025·2025-08-20
Knee tibial insert catalog number 341-16-704 recalled for mislabeled size or side
Enovis is recalling 18 EMPOWR 3D Knee tibial inserts, catalog number 341-16-704, lot 148T1057, because the implants carry incorrect size or side labeling.
Product
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0464-2025·2025-08-20
Strawberry con crema paleta 6-packs recalled for cream without milk declaration
La Michoacana Strawberry Con Crema 6-Pack Paletas, 16.5 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 33,105 units are affected.
Product
La Michoacana Strawberry Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00102-7
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0582-2025·2025-08-20
Metoprolol tartrate 100 mg tablets exceed the nitrosamine daily intake level
Metoprolol Tartrate Tablets USP 100 mg distributed by Westminster Pharmaceuticals are being recalled because N-nitroso-metoprolol was present above the established Acceptable Daily Intake level. 4,456 bottles affected.
Product
Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·H-0471-2025·2025-08-20
Choco-dipped mini paletas recalled because label lists cream but omits milk
Helados Mexico Choco-Dipped Minis Variety Paletas, 12-count 18 oz, are recalled nationwide because the label lists cream without declaring milk as its source. 42,564 units are affected.
Product
Helados Mexico Choco-Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-81215-5 UPC: 6-82082-41215-7
Category
Food
Distribution
Distributed nationwide