State

Massachusetts product recalls

72,940 recalls have nationwide distribution and so reach Massachusetts. 8,209 additional recalls listed Massachusetts specifically in their distribution scope.

What the numbers show

Total: 8,209
Critical: 1,171
Severe: 2,013
Most recent: 2026-09-09

Of the 8,209 recalls naming Massachusetts we have scored against our rubric, 1,171 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,013 (25%) are Severe.

Which agencies issued them

These figures cover only the 8,209 recalls whose distribution notice names Massachusetts specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3401–3425 of 81149

HighFDA (Devices)·Z-1238-2026·2026-02-11
Insulin pumps recalled over errors that suspend insulin delivery
Medtronic MiniMed is recalling 577 MiniMed 780G insulin pumps on software version 6.60 because a timing and processor communication issue may trigger Pump Error 43 or 41, suspending insulin delivery.
Product
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-1270-2026·2026-02-11
Sphincterotome KD-431Q-0720 recalled over a skipped thermoforming step
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-431Q-0720, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-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-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-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-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 (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-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-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-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 (Drugs)·D-0301-2026·2026-02-11
Bisoprolol and hydrochlorothiazide tablets recalled over a nitrosamine impurity
Unichem Pharmaceuticals USA is recalling a lot of Bisoprolol Fumarate and Hydrochlorothiazide tablets, 2.5 mg/6.25 mg, for not meeting the N-Nitroso Bisoprolol impurity specification limits.
Product
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE — BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE (BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE)
Category
Drug
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-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-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 (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-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-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-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-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
ModerateFDA (Devices)·Z-1228-2026·2026-02-11
Prismaflex M150 sets recalled over a deaeration chamber that may dislodge
Vantive US Healthcare is recalling 137,576 units of the PRISMAFLEX M150 SET because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Product
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
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-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-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-1221-2026·2026-02-11
Hematology diluents recalled over elevated platelet background check counts
Beckman Coulter is recalling 76,098 units of COULTER DxH Diluent and DxH ECO Diluent because specific lots contribute to elevated platelet Daily Checks background counts.
Product
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the
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