State

Hawaii product recalls

72,940 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 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3326–3350 of 75706

ModerateFDA (Devices)·Z-1273-2026·2026-02-11
Single use 3-lumen sphincterotomes recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-0725, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1268-2026·2026-02-11
CleverCut sphincterotomes recalled over a skipped thermoforming step
Olympus is recalling the CleverCut Single Use 3-Lumen Sphincterotome V, model KD-V411M-0320, because devices which did not undergo thermoforming could deform and lose performance.
Product
Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1272-2026·2026-02-11
Sphincterotome KD-V411M-0720 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-0720, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1287-2026·2026-02-11
Sphincterotome KD-401Q-0330 recalled over a skipped thermoforming step
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-401Q-0330, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1280-2026·2026-02-11
Sphincterotome KD-VC411Q-0320 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0320, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1286-2026·2026-02-11
Sphincterotome KD-411Q-0730 recalled over a skipped thermoforming step
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-411Q-0730, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0441-2026·2026-02-11
Energy drink recalled over a label understating its caffeine content
Fazt & Loud is recalling Lost and Found Energy, Sour Gummy Bear, because a label misprint states 150mg of caffeine when the product contains 300mg.
Product
Lost and Found Energy, Sour Gummy Bear, 12pck, 16oz Cans Case UPC: 850075595655 Can UPC: 850075595662 Aluminum Can Packaged
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1277-2026·2026-02-11
Sphincterotome KD-VC431Q-0730 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC431Q-0730, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1281-2026·2026-02-11
Sphincterotome KD-VC411Q-0330 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0330, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1279-2026·2026-02-11
Sphincterotome KD-VC411Q-0730 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0730, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1225-2026·2026-02-11
Prismaflex ST150 sets recalled over a deaeration chamber that may dislodge
Vantive US Healthcare is recalling 264,040 units of the PRISMAFLEX ST150 SET US because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Product
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1311-2026·2026-02-11
Four point sling bars recalled after a mounting bolt broke
ETAC A/S is recalling 25 Molift 4-point sling bars after a customer reported the bolt for mounting the lifting bar breaking during assembly and load testing.
Product
Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1300-2026·2026-02-11
Bubble sensors recalled over connecting cables that can be damaged
Maquet Cardiopulmonary is recalling 3,050 Bubble Sensors because excessive bending of the connecting cable can damage the Venous Bubble Sensor or cause loose cable contact.
Product
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1282-2026·2026-02-11
Sphincterotome KD-VC412Q-0215 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC412Q-0215, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1290-2026·2026-02-11
Sphincterotomes recalled over devices that skipped a thermoforming step
Olympus is recalling 3,954 Single Use 3-Lumen Sphincterotome V units because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1289-2026·2026-02-11
Sphincterotome KD-401Q-0730 recalled over a skipped thermoforming step
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-401Q-0730, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1291-2026·2026-02-11
Sphincterotome KD-V411M-1530 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-1530, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1310-2026·2026-02-11
Hoist sling bars recalled after a lifting bar mounting bolt broke
ETAC A/S is recalling 64 units of Molift 2-point sling bars, accessories to mobile hoists after a customer reported the bolt for mounting the lifting bar breaking during assembly and load testing.
Product
Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due t
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1293-2026·2026-02-11
Sphincterotome KD-401Q-0320 recalled over a skipped thermoforming step
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-401Q-0320, because devices which did not undergo thermoforming could deform and lose performance.
Product
Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-fr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1284-2026·2026-02-11
Sphincterotome KD-VC433Q-0730 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC433Q-0730, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency c
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1297-2026·2026-02-11
Sphincterotome KD-VC411Q-0725 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0725, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1278-2026·2026-02-11
Distal wire guided sphincterotomes recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC411Q-0720, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1296-2026·2026-02-11
Sphincterotome KD-V411M-3025 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-3025, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1292-2026·2026-02-11
Sphincterotome KD-V411M-3030 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-3030, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1231-2026·2026-02-11
Prismaflex TPE2000 sets recalled over a deaeration chamber that may dislodge
Vantive US Healthcare is recalling 13,760 units of the PRISMAFLEX TPE2000 SET because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Product
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide