Hawaii recalls
3231 federal recalls on file affecting Hawaii - 151 Hawaii-specific plus 3080 nationwide. Sourced from CPSC, FDA, USDA, and NHTSA.
- 2025-11-26FDA-DeviceMedtronicClass IINationwideMC3 VitalFlow Console, REF 58100; Blood pump of ecmo
As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.
- 2025-11-26FDA-DeviceThoratecClass IINationwideBrand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller Software Version: N/A Product Description: The HeartMate II System Controller is a small computer that controls and monitors system operation. It sends power and operating signals to the Left Ventricular Assist Device and adjusts device operation to maintain programme
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
- 2025-11-26FDA-DeviceThoratecClass IINationwideBrand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, EU Software Version: N/A Product Description: The HeartMate II LVAS is an axial-flow, rotary ventricular assist system that generates flows up to 10 liters per minute (lpm). One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the othe
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
- 2025-11-26FDA-DeviceThoratecClass IINationwideBrand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low Flow 2.0 Controller Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup s
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
- 2025-11-26FDA-DeviceThoratecClass IINationwideBrand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524 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 therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
- 2025-11-26FDA-DeviceBecton DickinsonClass IINationwideBD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
- 2025-11-26FDA-DeviceElektaClass IINationwideMOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3.4 (01)07340201500026(10)3.1.3.4 3.2.1.0 (01)07340201500071(10)3.2.1.0 3.2.1.1 (01)07340201500071(10)3.2.1.1 3.2.1.2 (01)07340201500071(10)3.2.1.2 3.2.1.3 (01)07340201500071(10)3.2.1.3 3.2.1.4 (01)07340201500071(10)
When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule.
- 2025-11-26FDA-DeviceCareFusionClass INationwideBD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.
- 2025-11-26FDA-FoodHaitaiClass IINationwideCinnamon Powder; 8oz clear plastic container. Distributed by Haitai Inc. UPC: 0 20914 81415 9
Elevated levels of lead in Cinnamon powder.
- 2025-11-26FDA-DrugICU MedicalClass INationwidePOTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly concentrated 100 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
- 2025-11-26FDA-DrugICU MedicalClass INationwidePOTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly concentrated 400 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7077-14
Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
- 2025-11-26FDA-DrugDermaRiteClass IINationwideUltraSure Anti-Perspirant & Deodorant, Aluminum Sesquichlorohydrate 15%, 118 mL (4 fl. oz.), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-266-04
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- 2025-11-26FDA-DrugDermaRiteClass IINationwideSan-E-Foam, Alcohol 67%, 1000 mL (34 fl. oz.) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-107-34
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- 2025-11-26FDA-DrugDermaRiteClass IINationwideRenew Skin Repair Cream, Dimethicone 1.5%, packaged in a) 5g tube (NDC 61924-405-05), b) 4 oz tube (NDC 61924-405-04), and c) 800 mL (NDC 61924-405-27), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- 2025-11-26FDA-DrugDermaRiteClass IINationwideRenew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-435-04
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- 2025-11-26FDA-DrugDermaRiteClass IINationwidePeriGuard Ointment, Petrolatum 49.9%, packaged in a) 5g (NDC 61924-205-05), b) 3.5oz (NDC 61924-205-04), and c) 7oz (NDC 61924-205-07) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- 2025-11-26FDA-DrugDermaRiteClass IINationwidePeriGiene, Health Care Antiseptic, Chloroxylenol 0.5%, 222mL (7.5 fl. oz.) bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-198-08
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- 2025-11-26FDA-DrugDermaRiteClass IINationwideMcKesson Skin Protectant, Lanolin USP, packaged in a) 5g (NDC 68599-6202-1), and b) 4oz NDC 68599-6203-4 tube, Distributed by McKesson Medical-Surgical Inc., Richmond, VA 23233.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- 2025-11-26FDA-DrugDermaRiteClass IINationwideLantiseptic, Skin Protectant, Lanolin USP 30%, packaged in a) 5g (0.17 oz) (NDC 61924-304-05), b)14.2g (0.5 oz)( NDC 61924-304-14), c) 4oz (NDC 61924-304-04), d) 4.5oz (NDC 61924-304-45), and e) 12oz (NDC 61924-304-12) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- 2025-11-26FDA-DrugDermaRiteClass IINationwideLantiseptic, Dry Skin Therapy, Lanolin USP 30%, packaged in a) 5 g (0.17 oz) (NDC 61924-504-05), b) 4 oz (NDC 61924-504-04), and c)14 oz (NDC 61924-710-14) tubes, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- 2025-11-26FDA-DrugDermaRiteClass IINationwideKleenFoam Antimicrobial Foam Soap, Chloroxylenol 0.5%, 34 FL OZ (1000 mL) per cartridge, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-093-34
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- 2025-11-26FDA-DrugDermaRiteClass IINationwideHand-E-Foam, Benzethonium Chloride 0.20%, packaged in a) 236mL (NDC 61924-102-08) and b) 1000 mL (NDC 61924-102-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- 2025-11-26FDA-DrugDermaRiteClass IINationwideGelRite Instant Hand Sanitizer, Alcohol 65%, packaged in a) 118 mL (NDC 61924-106-04), b) 473 mL (NDC 61924-106-16) and c) 800 mL (NDC 61924-106-27), and d) 1000 mL (NDC 61924-106-34) per container, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- 2025-11-26FDA-DrugDermaRiteClass IINationwideDermaSarra, Camphor 0.5%, External Analgesic, 222 mL (7.5 fl. oz.) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-189-08
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- 2025-11-26FDA-DrugDermaRiteClass IINationwideDermaMed Ointment, Skin Protectant, Aluminum Hydroxide Gel 2%, Net Wt. 106 g (3.75 oz.) per tube, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-214-04
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- 2025-11-26FDA-DrugDermaRiteClass IINationwideDermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E, Chloroxylenol 0.2%, packaged in a) 222 mL (7.5 fl. oz.) per tube (NDC 61924-092-08), b) 800 mL (27 fl. oz.) per bag (NDC 61924-092-27), and c 1000 mL (34 fl. oz.) per bag (NDC 61924-092-34), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- 2025-11-26FDA-DrugDermaRiteClass IINationwideDermaFungal, Antifungal Cream with 2% Miconazole Nitrate, packaged in a) 5 g (0.18 oz) per packet (NDC 61924-234-05), and b)106 g (3.75 oz.) per tube (NDC 61924-234-04) DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- 2025-11-26FDA-DrugDermaRiteClass IINationwideDermaCerin, Skin Protectant Moisturizing Cream (petrolatum 33%), packaged in a) 106 g (3.75 oz.) per tube (NDC 61924-174-04) and b) 454 g (16 oz.) per jar (NDC 61924-174-16), DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047.
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- 2025-11-26FDA-DrugDermaRiteClass IINationwide4-N-1 Skin Protectant, No Rinse Wash Cream with Dimethicone 1%, 113g, (4 oz) per bottle, DermaRite Industries LLC, 7777 West Side Avenue, North Bergen, NJ 07047. NDC 61924-208-04
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
- 2025-11-26FDA-DrugZydusClass IINationwideBromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. NDC 68382-110-06
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
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