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.

3426–3450 of 81149

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-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-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-1224-2026·2026-02-11
Prismaflex ST100 sets recalled over a deaeration chamber that may dislodge
Vantive US Healthcare is recalling 87,436 units of the PRISMAFLEX ST100 SET US because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Product
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1288-2026·2026-02-11
Sphincterotome KD-401Q-0720 recalled over a skipped thermoforming step
Olympus is recalling the Disposable Triple Lumen Sphincterotome, model KD-401Q-0720, because devices which did not undergo thermoforming could deform and lose performance.
Product
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-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-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 (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 (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-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-1230-2026·2026-02-11
Prismaflex HF1000 sets recalled over a deaeration chamber that may dislodge
Vantive US Healthcare is recalling 115,112 units of the PRISMAFLEX HF1000 SET because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
Product
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
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-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-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 (Food)·H-0442-2026·2026-02-11
Collagen supplement recalled over manganese below the labeled quantity
Optiwize is recalling 78 units of OptiWize Collagen Plus, 320 count, after NSF testing showed the manganese level was below the label quantity.
Product
OptiWize Health OptiWize Collagen Plus 320 count bottle; White bottle with black lid.
Category
Food
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-1242-2026·2026-02-11
NAEOTOM Alpha.Pro software applications recalled over missing FDA clearance
Siemens is removing three software applications from two NAEOTOM Alpha.Pro CT systems because the applications have not received FDA 510(k) clearance.
Product
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
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-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-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 (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 (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-1309-2026·2026-02-11
Mobile hoists recalled after a lifting bar mounting bolt broke
ETAC A/S is recalling 71 units of Molift Mover 300 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 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional
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-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-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