State

Hawaii product recalls

72,969 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 72,969 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

4826–4850 of 75736

HighFDA (Devices)·Z-0202-2026·2025-10-22
Three valve solution sets recalled from one lot because sets may leak
Baxter is recalling 12,720 CLEARLINK System Continu-Flo solution sets with three luer activated valves from one lot because the IV sets may leak.
Product
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0158-2026·2025-10-22
Humidifier devices recalled because power loss alert sounds under two minutes
Fisher & Paykel is recalling 51,144 Airvo 2 and myAirvo 2 humidifiers because an unintentional power disconnection may sound an audible alert for less than 120 seconds.
Product
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0181-2026·2025-10-22
Caesarean section packs recalled after being sterilized more than once
American Contract Systems is recalling C-section convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits Item Number/Description FHCP08Y C SECTION PK HICS50I C-SECTION PACK HSCB90B C-SECTION BASIN PACK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0170-2026·2025-10-22
Basic biopsy trays recalled after entire lot was sterilized more than once
American Contract Systems is recalling a Basic Biopsy Tray lot that was re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Basic Biopsy Tray, Item Number NMBP44L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0155-2026·2025-10-22
Ultrasound systems recalled over inaccurate liver steatosis measurement values
GE is recalling 65 LOGIQ P10 series systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.
Product
LOGIQ P10 series with software version R4.5.7 Model Number 5877534
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0160-2026·2025-10-22
Wound dressings recalled because foreign matter may be on the product
ConvaTec is recalling 80,980 DuoDERM Extra Thin dressings from one lot because the wound dressing may have foreign matter on the product.
Product
DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM"
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0156-2026·2025-10-22
LOGIQ P10 HD systems recalled over inaccurate liver steatosis measurement values
GE is recalling 31 LOGIQ P10 R4.5 HD ultrasound systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.
Product
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0172-2026·2025-10-22
General and laparotomy packs recalled after being sterilized more than once
American Contract Systems is recalling general, chest, laparotomy and interventional radiology convenience packs that were re-gassed after a sterilization nonconformance.
Product
Medical convenience kits Item number/ Product description AKGN82E GENERAL AMCB08Y CHEST BREAST PACK ANBP10AC BASIC PACK - 205939 ANIR77AM INTERVENTIONAL RADIOLOGY PACK - 205953 CFLA39G LAPAROTOMY PACK CIBL33I BASIC LAP PACK EVMN24E MINOR ESC EVST48E STARTER FDTA11AA
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0197-2026·2025-10-22
Forty four inch extension sets recalled because the IV sets may leak
Baxter is recalling 15,552 CLEARLINK System 44-inch straight-type extension sets from one lot because the IV sets may leak.
Product
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0142-2026·2025-10-22
CX preconnect pumps recalled over inflation and deflation performance issues
Boston Scientific is recalling 2,288 CX Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.
Product
CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 72404435 (12CM IP IZ), (7) 72404436 (15CM IP IZ), (8) 72404437 (18CM IP IZ), (9)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0177-2026·2025-10-22
Central line insertion kits recalled after being sterilized more than once
American Contract Systems is recalling 32,433 adult central line insertion supply kits that were re-gassed after a nonconformance, without validation for multiple sterilization cycles.
Product
Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0168-2026·2025-10-22
Twelve foot display cables recalled over inadequate shielding and interference
Spacelabs Healthcare is recalling 820 twelve-foot DVI display cables because inadequate shielding may allow electromagnetic interference with other electronically sensitive medical devices in use.
Product
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0042-2026·2025-10-22
Frozen burrito bowl blend recalled because it may contain undeclared shrimp
One Frozen is recalling 57,240 bags of Good and Gather Southwest-Style Burrito Bowl Blend because the product may contain undeclared shrimp.
Product
Good and Gather brand Southwest-Style Burrito Bowl Blend Processed in a facility that also handles shellfish, egg, fish, milk, sesame, soy, tree nut and wheat ingredients
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0190-2026·2025-10-22
Duo-vent solution sets recalled across three lots because sets may leak
Baxter is recalling 136,512 CLEARLINK System DUO-VENT solution sets across three lots because the IV sets may leak.
Product
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0178-2026·2025-10-22
Head and neck procedure packs recalled after being sterilized more than once
American Contract Systems is recalling ENT and head and neck convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits Item Number/Description RCEN25B ENT SDSC 0246972 RCHN27D HEAD AND NECK RCH 0246951
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0186-2026·2025-10-22
PICC and gastrostomy tube packs recalled after being sterilized more than once
American Contract Systems is recalling PICC G-Tube convenience packs that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0194-2026·2025-10-22
Three valve retractable collar sets recalled across many lots for leak potential
Baxter is recalling 1,167,120 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a retractable collar because the IV sets may leak.
Product
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0140-2026·2025-10-22
CX preconnect pumps without InhibiZone recalled over inflation deflation issues
Boston Scientific is recalling CX Preconnect with TENACIO Pump without InhibiZone because of the potential for inflation or deflation performance issues or difficulties.
Product
CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0191-2026·2025-10-22
Non-vented IV solution sets recalled from one lot because sets may leak
Baxter is recalling 1,440 CLEARLINK System non-vented solution sets from one lot because the IV sets may leak.
Product
CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0157-2026·2025-10-22
LOGIQ P9 ultrasound systems recalled over inaccurate liver steatosis measurements
GE is recalling 37 LOGIQ P9 R4.5 ultrasound systems running software R4.5.7 because the Ultrasound-Guided Attenuation Parameter measurement may display inaccurate liver steatosis values.
Product
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0196-2026·2025-10-22
Three valve filtered solution sets recalled because IV sets may leak
Baxter is recalling 8,368 CLEARLINK System Continu-Flo solution sets with three luer activated valves and a 0.2 micron filter from one lot because the IV sets may leak.
Product
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2C8593
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0029-2026·2025-10-22
Parkinson's tablets recalled after bottles contained a higher strength tablet
Rising Pharma is recalling 2,064 bottles of Carbidopa, Levodopa and Entacapone Tablets 25/100/200 mg after a sealed bottle was found to contain the 37.5/150/200 mg strength instead.
Product
CARBIDOPA, LEVODOPA AND ENTACAPONE — CARBIDOPA, LEVODOPA AND ENTACAPONE (CARBIDOPA, LEVODOPA AND ENTACAPONE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0176-2026·2025-10-22
Cardiovascular procedure packs recalled after being sterilized more than once
American Contract Systems is recalling cardiovascular convenience kits that were re-gassed after a sterilization nonconformance, without validation for multiple cycles.
Product
Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PACK - 209533 UICD62AN CARDIOVASCUALR SUPPLY (PS 907285) UICT16F CARDIO THORACIC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0144-2026·2025-10-22
LGX preconnect pumps recalled over inflation and deflation performance issues
Boston Scientific is recalling 490 LGX Preconnect devices with TENACIO Pump and InhibiZone because of the potential for inflation or deflation performance issues or difficulties.
Product
LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0175-2026·2025-10-22
Cardiac catheterization packs recalled after being sterilized more than once
American Contract Systems is recalling cardiac catheterization and cath lab convenience packs that were re-gassed after a sterilization nonconformance.
Product
Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 923077) UIRD89AH RADIAL PACK (PS 56573)
Category
Medical Device
Distribution
Distributed nationwide