State

North Dakota product recalls

72,936 recalls have nationwide distribution and so reach North Dakota. 2,921 additional recalls listed North Dakota specifically in their distribution scope.

What the numbers show

Total: 2,921
Critical: 265
Severe: 727
Most recent: 2026-09-02

Of the 2,921 recalls naming North Dakota we have scored against our rubric, 265 (9%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 727 (25%) are Severe.

Which agencies issued them

These figures cover only the 2,921 recalls whose distribution notice names North Dakota specifically. The 72,936 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3326–3350 of 75857

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-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-1269-2026·2026-02-11
Sphincterotome KD-VC431Q-0720 recalled over a skipped thermoforming step
Olympus is recalling the Single Use Sphincterotome V (Distal Wire guided), model KD-VC431Q-0720, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 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-1275-2026·2026-02-11
Sphincterotome KD-V431M-0720 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V431M-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-V431M-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 (Drugs)·D-0342-2026·2026-02-11
Diclofenac topical gel recalled after failing viscosity specifications
Sun Pharmaceutical Industries is recalling a lot of Diclofenac Sodium Topical Gel, 3%, after an out of specification viscosity result slightly below the limit.
Product
DICLOFENAC SODIUM — DICLOFENAC SODIUM (DICLOFENAC SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1276-2026·2026-02-11
Sphincterotome KD-V431M-0730 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V431M-0730, 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-V431M-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 current.
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-1254-2026·2026-02-11
Illuminated depressors recalled with no reason given in the record
Vortex Surgical is recalling the TID Pharos Illuminated Depressor, VS0801B. The reason field in the enforcement record reads only "XXX", so no hazard is stated.
Product
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1239-2026·2026-02-11
SOMATOM X.ceed software applications recalled over missing FDA clearance
Siemens is removing three software applications from two SOMATOM X.ceed CT systems because the applications have not received FDA 510(k) clearance.
Product
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1295-2026·2026-02-11
Sphincterotome KD-V411M-3020 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-3020, 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-3020 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-1229-2026·2026-02-11
Prismaflex HF1000 set 107140 recalled over a dislodging deaeration chamber
Vantive US Healthcare is recalling 93,576 Prismaflex HF1000 Sets, product code 107140, because the deaeration chamber may dislodge from the Prismaflex Control Unit.
Product
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1283-2026·2026-02-11
Sphincterotome KD-VC433Q-0720 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V (Distal Wire guided), model KD-VC433Q-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-VC433Q-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-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-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-1308-2026·2026-02-11
Molift Mover 205 hoists recalled after a mounting bolt broke
ETAC A/S is recalling 95 Molift Mover 205 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 Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402-01, (7) M14050-00 (8) M14001;
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-1271-2026·2026-02-11
Sphincterotome KD-V411M-0330 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-0330, 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-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 current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1227-2026·2026-02-11
Prismaflex M100 sets recalled over a deaeration chamber that may dislodge
Vantive US Healthcare is recalling 230,596 Prismaflex M100 Sets because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Product
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1240-2026·2026-02-11
NAEOTOM Alpha software applications recalled because they lack FDA clearance
Siemens is removing three software applications from 88 NAEOTOM Alpha CT systems because the applications have not received FDA 510(k) clearance.
Product
NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1294-2026·2026-02-11
Triple lumen sphincterotomes recalled over a skipped thermoforming step
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-401Q-0725, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 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-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-1226-2026·2026-02-11
Oxiris sets recalled over a deaeration chamber that may dislodge
Vantive US Healthcare is recalling 2,724 Oxiris Sets because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Product
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1241-2026·2026-02-11
CT software applications recalled because they lack FDA clearance
Siemens is removing three software applications from five NAEOTOM Alpha.Prime CT systems because the applications have not received FDA 510(k) clearance.
Product
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1274-2026·2026-02-11
Sphincterotome KD-V411M-0730 recalled over a skipped thermoforming step
Olympus is recalling the Single Use 3-Lumen Sphincterotome V, model KD-V411M-0730, 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-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 current.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1285-2026·2026-02-11
Sphincterotome KD-411Q-0720 recalled over a skipped thermoforming step
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-411Q-0720, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 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