State

Hawaii product recalls

72,913 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 72,913 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

2026–2050 of 75679

HighFDA (Devices)·Z-1960-2026·2026-05-06
Philips Ingenia Ambition S MRI Systems Recalled for Stiffness Value Errors
Philips is recalling certain Ingenia Ambition S MRI systems with MR Elastography software due to potential stiffness value errors that may occur when specific image reconstruction parameters are used in combination with Resoundant's algorithm.
Product
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2001-2026·2026-05-06
Abbott i-STAT Blood Gas Cartridges Reporting Inaccurate pH and PCO2 Results
Abbott Point Of Care Inc. is recalling approximately 7.6% of i-STAT G3+, i-STAT EG6+, and i-STAT EG7+ blood gas cartridges due to a manufacturing issue causing falsely high PCO2 and low pH readings, which may lead to unnecessary or harmful clinical interventions.
Product
i-STAT G3+ cartridge; List Number: 03P78-26;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2041-2026·2026-05-06
Medline and Centurion Medical Convenience Kits Recalled for Non-Sterile Alcohol Prep Pads
Medline Industries is recalling specific lots of medical convenience kits containing non-sterile Webcol Large Alcohol Prep Pads due to discovery of Paenibacillus phoenicis contamination. Affected kits were distributed nationwide.
Product
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. FOLEY CARE KIT, Medline Kit SKU UROT1044; 2. IV START KIT WITH EXTENSION TUBING, Medline Kit SKU IV8770; 3. IV START KIT, Medline Kit SKU DYNDV2520; 4. ARTERIAL LINE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1951-2026·2026-05-06
Philips Achieva 1.5T MRI Scanner Stiffness Calculation Error Recall
Philips is recalling Achieva 1.5T MRI systems with MR Elastography software due to potential stiffness value errors that may occur with specific image reconstruction parameters, causing incorrect voxel size display in the default scan protocol.
Product
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1983-2026·2026-05-06
BD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
Becton Dickinson & Co. is recalling certain lots of BD GasPak EZ Campy Gas Generating Pouch Systems because gas generating sachets may produce carbon dioxide levels below specification, potentially affecting microbiologic laboratory testing.
Product
BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1993-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral implant sterility concern
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral RT SZ 8 CEM implants due to external sterile packaging adhered to internal sterile packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1982-2026·2026-05-06
BD GasPak EZ CO2 Pouch System gas generating sachets underperforming
Becton Dickinson is recalling certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems because gas generating sachets may produce carbon dioxide levels below specification.
Product
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1967-2026·2026-05-06
Philips SmartPath to dStream MR Elastography Software Parameter Error
Philips is recalling specific units of SmartPath to dStream for XR and 3.0T with MR Elastography due to potential stiffness value errors when certain image reconstruction parameters are used with Resoundant's algorithm, which may cause voxel size settings in the default MRE scan protocol to display incorrectly.
Product
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1985-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Recall
DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral Left Size 4 Cement prosthetic components because external sterile packaging was found adhered to internal packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1959-2026·2026-05-06
Philips Ingenia 3.0T CX MRI System MR Elastography Software Issue
Philips is recalling Ingenia 3.0T CX MRI systems with MR Elastography due to potential stiffness value errors caused by specific image reconstruction parameters and Resoundant algorithm settings, resulting in incorrect voxel size displays in the default MRE scan protocol.
Product
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0508-2026·2026-05-06
Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations
Wells Pharma is recalling fentanyl citrate injectable solution (50 mcg/5mL, NDC 73702-202-15) nationwide due to cGMP manufacturing deviations. The recall affects 50 syringes from Lot 020226202150202 with expiration date 05/05/2026.
Product
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharma, NDC 73702-202-15.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0502-2026·2026-05-06
Injectable Phenylephrine Hydrochloride Solution Recall Due to cGMP Deviations
Wells Pharma of Houston LLC is recalling Phenylephrine Hydrochloride Injectable Solution, 40 mg, 250 mL IV bags nationwide due to cGMP deviations. The recall affects 13,070 IV bags with multiple lot numbers and expiration dates through July 2026.
Product
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 73702-122-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0685-2026·2026-05-06
Calypso Tropic Tango Lemonade contains undeclared Yellow No. 5
Calypso Tropic Tango Lemonade is being recalled because it contains undeclared Yellow No. 5. The action covers 299,779 cases distributed nationwide and to four other markets.
Product
Calypso Tropic Tango Lemonade. 16 FL oz (1PT) (473 ML). UPC 0 79581-18709 7. Keep Refrigerated After Opening. King Juice Company, Inc., Milwaukee, Wisconsin 53221.
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0504-2026·2026-05-06
Fentanyl Citrate Injectable Solution Recalled for cGMP Deviations
Wells Pharma of Houston is voluntarily recalling 2,940 IV bags of fentanyl citrate injectable solution due to cGMP (current good manufacturing practice) deviations. The product was distributed nationwide.
Product
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg per mL), 250 mL bag, wells pharma of Houston, NDC 73702-202-03.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1964-2026·2026-05-06
Philips MR 7700 MR Elastography device stiffness value error recall
Philips is recalling certain MR 7700 devices with MR Elastography due to potential stiffness value errors when specific image reconstruction parameters are used, which may cause voxel size settings to display incorrectly.
Product
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1950-2026·2026-05-06
HiResolution Bionic Ear Battery Pak Fails Safety Door Compliance
Advanced Bionics is recalling HiResolution Bionic Ear System M Zn-Air Battery Paks because the non-tamperproof battery door does not require a tool to open, violating safety standards. The issue affects 45,173 units distributed worldwide.
Product
Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI-5501-270; CI-5501-280 Software Version: Not Applicable
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1952-2026·2026-05-06
Philips Achieva 1.5T MRI System MRE Protocol Parameter Error Recall
Philips Achieva 1.5T MRI systems with MR Elastography may display incorrect stiffness values and voxel size settings when certain image reconstruction parameters are used together, potentially affecting diagnostic accuracy.
Product
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0500-2026·2026-05-06
iVIZIA Dry Eye Lubricant Drops Recalled for Sterility Assurance
Thea Pharma, Inc. is recalling iVIZIA Dry Eye (Povidone 0.5%) lubricant eye drops nationwide due to the FDA's discovery of manufacturing process deviations that affect the product's sterility assurance.
Product
IVIZIA DRY EYE — IVIZIA DRY EYE (POVIDONE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2004-2026·2026-05-06
Philips Bridge Prep Kit catheter may experience resistance during advancement
Merit Medical Systems, Inc. is recalling the Philips Bridge Prep Kit (Ref K12-09098C) because the catheter may experience resistance when being advanced over the guidewire during use.
Product
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0507-2026·2026-05-06
Ketamine Hydrochloride Injectable Solution Recalled for cGMP Deviations
Wells Pharma of Houston LLC is recalling 4,975 syringes of Ketamine Hydrochloride Injectable Solution (50 mg/mL) distributed nationwide due to current Good Manufacturing Practice (cGMP) deviations.
Product
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, Houston, TX 77054, NDC 73702-302-31.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1953-2026·2026-05-06
Philips Achieva 3.0T MR Elastography system stiffness value error recall
Philips is recalling the Achieva 3.0T with MR Elastography system due to potential stiffness value errors in image reconstruction when specific parameters are used, which may cause incorrect voxel size display in the default scan protocol.
Product
Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1961-2026·2026-05-06
Philips Ingenia Ambition X MRI Systems Stiffness Value Error Recall
Philips Ingenia Ambition X MRI systems with MR Elastography may produce incorrect stiffness values due to image reconstruction parameter errors, affecting diagnostic accuracy.
Product
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0526-2026·2026-05-06
Alendronate Sodium Oral Solution Recalled for Out-of-Specification Assay Results
Hikma Pharmaceuticals USA Inc. is recalling Alendronate Sodium Oral Solution 70 mg/75 mL due to out-of-specification assay results found in a limited number of bottles. The affected lot (AC2040A) was distributed nationwide.
Product
ALENDRONATE SODIUM — ALENDRONATE SODIUM (ALENDRONATE SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1988-2026·2026-05-06
DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall
DePuy Synthes is recalling 3 units of ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM due to external sterile packaging adhered to internal packaging, potentially compromising sterility.
Product
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1946-2026·2026-05-06
Disposable Mixing Bowls with Spatula recalled for compromised sterile barrier
Zimmer, Inc. is recalling Disposable Mixing Bowls with Spatula (Model 00-5049-011-00) due to package seal defects that may compromise the sterile barrier. Ten complaints have been received identifying incomplete seals, wrinkles, or peeling seals.
Product
Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A
Category
Medical Device
Distribution
Distributed nationwide