State

Massachusetts product recalls

72,971 recalls have nationwide distribution and so reach Massachusetts. 8,211 additional recalls listed Massachusetts specifically in their distribution scope.

What the numbers show

Total: 8,211
Critical: 1,171
Severe: 2,013
Most recent: 2026-09-16

Of the 8,211 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 8,211 recalls whose distribution notice names Massachusetts specifically. The 72,971 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

6101–6125 of 81182

HighFDA (Devices)·Z-2151-2025·2025-07-30
Nellcor bedside SpO2 monitor alarms may not be heard or recognized
The Covidien Nellcor Bedside SpO2 Patient Monitoring System is being recalled because alarms may not be heard or recognized, which the manufacturer links to treatment delay. 264,790 units are affected.
Product
Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2169-2025·2025-07-30
CareLink SmartSync limited the window to abort a high voltage therapy
Medtronic CareLink SmartSync Device Manager is being updated because in prior application versions the abort window during an induction test limited the user's ability to cancel high voltage therapy. 22,091 devices affected.
Product
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Mod
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2131-2025·2025-07-30
SIGNA Architect AIR gradient coils can produce acoustic noise above limit
GE HealthCare SIGNA Architect AIR MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.
Product
SIGNA Architect AIR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2162-2025·2025-07-30
BD COR system software issue could produce possible false negative results
BD COR System Software version 8.80 and above is being recalled because of a potential functionality issue supporting the Over labeling feature that could lead to possible false negative results. 7 systems affected.
Product
BD COR System Software. Model Number: 444829.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2136-2025·2025-07-30
Endosee system convenience trays label non-sterile iodine pouches as sterile
Endosee System Convenience Kits are being recalled because they contain non-sterile iodine pouches while the peel away lid labels incorrectly identify them as sterile. 991 units are affected.
Product
Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2170-2025·2025-07-30
Stryker StrykeFlow suction irrigator may leak solution into the handpiece
The Stryker StrykeFlow Disposable Suction/Irrigator is being recalled because irrigation solution may leak into the handpiece and battery pack, causing it to malfunction.
Product
Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2168-2025·2025-07-30
SmartSync Patient Connector limited the window to abort high voltage therapy
The Medtronic CareLink SmartSync Patient Connector is being updated because in prior application versions the abort window during an induction test limited the user's ability to cancel high voltage therapy. 22,091 devices affected.
Product
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2137-2025·2025-07-30
Endosee convenience kits label non-sterile iodine pouches as sterile
Endosee System Convenience Kits with IV Tube are being recalled because they contain non-sterile iodine pouches while the peel away lid labels incorrectly identify them as sterile. 475 units affected.
Product
Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0541-2025·2025-07-30
Budesonide inhalation ampoules recalled after leakage and empty ampoule complaint
Budesonide Inhalation Suspension 0.5 mg/2 mL is being recalled for lack of assurance of sterility after a market complaint was received for leakage and an empty ampoule. 13,680 ampoules affected.
Product
BUDESONIDE — BUDESONIDE (BUDESONIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2134-2025·2025-07-30
Azurion 7 M20 C-arm gearbox mounting bolts may become loose
The Azurion 7 M20 fluoroscopic x-ray system is being recalled because of the potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. 78 units affected.
Product
Azurion 7 M20. Fluoroscopic X-Ray System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0325-2025·2025-07-30
Ritz cracker sandwich variety packs recalled over undeclared peanut from mispackaging
Ritz Cracker Sandwiches 20 count variety packs are being recalled because of undeclared peanut allergens due to mispackaging. 13,872 cases are affected.
Product
Ritz Cracker Sandwiches, Variety 20 count variety Pack, (20- Packs of 10 Cheese 1.35 oz Packs and 10 Peanut Butter 1.38 oz Packs) Net Wt. 27.3 oz (20-1.38 oz packet of cracker sandwiches inside cartons of varying sizes). 20-27.3 OZ (Case: 6 - 27.3 Oz Cartons in master carton. UP
Category
Food
Distribution
49 states
HighFDA (Drugs)·D-0535-2025·2025-07-30
Compounded epinephrine lidocaine vials returned subpotent assay results in stability testing
Epinephrine Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL vials compounded by Imprimis NJOF are being recalled because of subpotent assay results during stability testing. 6,880 vials affected.
Product
Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2171-2025·2025-07-30
Stryker StrykeFlow irrigator with tip may leak solution into handpiece
The Stryker StrykeFlow Disposable Suction/Irrigator with Disposable Tip is being recalled because irrigation solution may leak into the handpiece and battery pack, causing it to malfunction.
Product
Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0324-2025·2025-07-30
Ritz peanut butter cracker 40 count cartons recalled over undeclared peanut
Ritz Peanut Butter Cracker Sandwiches in 55.2 oz 40 count cartons are being recalled because of undeclared peanut allergens due to mispackaging. 224 cases are affected.
Product
Ritz Peanut Butter Cracker Sandwiches, Net Wt. 55.2 oz, 40 count (40x1.38 oz 6 pack of cracker sandwiches inside carton. 40 - 55.2oz Cartons in master carton. UPC 0 44000 07819 5
Category
Food
Distribution
49 states
HighFDA (Devices)·Z-2165-2025·2025-07-30
Biofinity XR Toric contact lens blisters may have a leaking seal
Biofinity XR Toric Contact Lenses are being recalled because lens blisters may have an incomplete or leaking seal, which may render them unsterile. 397 units are affected.
Product
Biofinity XR Toric Contact Lens
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2133-2025·2025-07-30
SIGNA PET/MR gradient coils can produce acoustic noise above the limit
GE HealthCare SIGNA PET/MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.
Product
SIGNA PET/MR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2130-2025·2025-07-30
SIGNA Architect gradient coils can produce acoustic noise above the limit
GE HealthCare SIGNA Architect MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.
Product
SIGNA Architect
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0326-2025·2025-07-30
Ritz peanut butter cracker sandwiches recalled over undeclared peanut from mispackaging
Ritz Peanut Butter Cracker Sandwiches are being recalled because of undeclared peanut allergens due to mispackaging. 37,985 units are affected across nearly every state.
Product
Ritz Peanut Butter Cracker Sandwiches, Net Wt. 11.4 oz, 8 count (8x1.38 oz 6 pack of cracker sandwiches inside carton. 14X8-Case: 14 - 11.04 Oz Cartons in master carton. UPC 0 44000 88210 5
Category
Food
Distribution
49 states
HighFDA (Food)·H-0323-2025·2025-07-30
Ritz peanut butter cracker 20 count cartons recalled over undeclared peanut
Ritz Peanut Butter Cracker Sandwiches in 27.6 oz 20 count cartons are being recalled because of undeclared peanut allergens due to mispackaging. 24,446 cases are affected.
Product
Ritz Peanut Butter Cracker Sandwiches, Net Wt.27.6 oz, 20 count (20x1.38 oz) 6- pack of cracker sandwiches inside cartons. And 6x20(6 - 27.6 oz Cartons) in master carton. UPC 1 00 44000 07584 2
Category
Food
Distribution
49 states
HighFDA (Devices)·Z-2132-2025·2025-07-30
Discovery MR750w gradient coils can produce acoustic noise above the limit
GE HealthCare Discovery MR750w 3.0T MR systems are being recalled because gradient coils can produce acoustic levels exceeding the 99 dB limit set by IEC 60601-2-33 during scanning.
Product
Discovery MR750w 3.0T
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0307-2025·2025-07-30
Middle East Coast tahini dip may contain spoilage organisms
Middle East Coast brand Tahini Dip in 6 oz tubs is being recalled because the product may be contaminated with spoilage organisms. 658 tubs are affected.
Product
Middle East Coast brand Tahini Dip; NET WT: 6 OZ (170g); INGREDIENTS: TAHINI, ORGANIC LEMON JUICE, GARLIC, OLIVE OIL, SEA SALT, ORGANIC TOASTED SESAME. CONTAINS SESAME; Locally Crafted by SHOVEL AND SPOON; UPC 8 60005 50281 3
Category
Food
Distribution
3 states
ModerateFDA (Drugs)·D-0536-2025·2025-07-30
Compounded quadruple ophthalmic solution returned subpotent assay results in stability testing
A compounded Tropicamide-Proparacaine-Phenylephrine-Ketorolac sterile ophthalmic solution is being recalled because of subpotent assay results during stability testing. 2,890 vials are affected.
Product
Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution, 1% 0.5% 2.5% 0.5%, 5mL, 2x5ML vial per carton, Rx Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-733-05.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0537-2025·2025-07-30
Clomipramine capsules failed a degradation product specification at expiry testing
Clomipramine Hydrochloride Capsules USP 25 mg are being recalled after an out of specification result for an unspecified degradation product during retention sample testing at expiry. 2,724 bottles affected.
Product
CLOMIPRAMINE HYDROCHLORIDE — CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE CAPSULES)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2163-2025·2025-07-30
ACUVUE OASYS MAX multifocal daily lenses have bubbles and voids
ACUVUE OASYS MAX 1-Day MULTIFOCAL contact lenses are being recalled because of defects, specifically bubbles and voids, identified during standard finished goods testing. 114,165 lenses affected.
Product
ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·25E046000·2025-07-29
Terran Industries Recalls 7000lb Axle Assemblies Due to Suspension Defect
Terran Industries is recalling 7000lb axle assemblies because incorrect suspension components may have been installed, posing a risk of axle spring failure or wheel detachment.
Product
SUSPENSION:MULTIPLE AXLE recall
Category
Vehicle
Distribution
Distributed nationwide