State

Massachusetts product recalls

73,092 recalls have nationwide distribution and so reach Massachusetts. 8,239 additional recalls listed Massachusetts specifically in their distribution scope.

What the numbers show

Total: 8,239
Critical: 1,181
Severe: 2,025
Most recent: 2026-09-23

Of the 8,239 recalls naming Massachusetts we have scored against our rubric, 1,181 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,025 (25%) are Severe.

Which agencies issued them

These figures cover only the 8,239 recalls whose distribution notice names Massachusetts specifically. The 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

9001–9025 of 81331

HighFDA (Devices)·Z-0628-2025·2024-12-11
MEDLINE dental and oral surgery kits recalled due to defective component
MEDLINE is recalling four types of dental and oral surgery convenience kits that were manufactured using SafeAir Smoke Evacuation Pencils, which were previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ80226A; 4) DENTAL MINOR PACK, REF DYNJ83140
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0631-2025·2024-12-11
Medline Convenience Kits Recalled Due to Defective Component
Medline Industries is recalling 70 convenience kits containing SafeAir Smoke Evacuation Pencil components that were subsequently recalled by Stryker. The affected product types are General Endoscopy Pack and Endo Bladder Pack.
Product
MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO BLADDER PACK, REF DYNJ49672L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0105-2025·2024-12-11
Duloxetine Delayed-Release Capsules Nationwide Recall for N-Nitroso Impurity
Rising Pharma recalls Duloxetine Delayed-Release Capsules 20 mg nationwide due to N-nitroso-duloxetine impurity exceeding recommended interim limits, affecting 209,376 bottles.
Product
Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0104-2025·2024-12-11
Sunitinib Malate Capsules Recalled Due to Label Mix-Up
AvKARE is recalling Sunitinib Malate 25 mg capsules nationwide due to a label mix-up in lot 100049501. The FDA has classified this as a Class II recall.
Product
SUNITINIB MALATE — SUNITINIB MALATE (SUNITINIB MALATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0639-2025·2024-12-11
Medline Convenience Kits Recalled Due to Defective Smoke Evacuation Component
Medline is recalling L&D convenience kits distributed nationwide because they were manufactured with smoke evacuation pencils that Stryker subsequently recalled. The affected kits contain components from lot 23HMI048.
Product
MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0622-2025·2024-12-11
Medline Tracheostomy Convenience Kits Recalled Due to Defective Component
Medline is recalling 88 units of tracheostomy convenience kits containing a defective smoke evacuation pencil component that was previously recalled by Stryker. Products were distributed nationwide.
Product
MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0617-2025·2024-12-11
Hollister CalciCare Calcium Alginate Dressing Recalled for Packaging Defect
Advanced Medical Solutions is recalling Hollister CalciCare Calcium Alginate Dressing (Model 529937R, Lot W00070134) due to defects in the primary packaging pouch that compromise sterile barrier integrity. The affected dressing was distributed nationwide to IL, TX, and VA.
Product
Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds such as: ¿ pressure ulcers ¿ leg ulcers ¿ cavity wounds ¿ lacerations ¿ post-operative surgical wounds
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0638-2025·2024-12-11
MEDLINE medical convenience kits recalled for defective component
Medline is recalling medical convenience kits (CLEAN CLOSING PACK and CLEAN CLOSURE PACK GREEN) distributed nationwide because they contain a SafeAir Smoke Evacuation Pencil component that was recalled by Stryker.
Product
MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84667
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0096-2025·2024-12-11
Prescription Drug Diltiazem Hydrochloride Recalled for Manufacturing Impurity
Glenmark Pharmaceuticals is recalling 5,232 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to an impurity that exceeds FDA safety limits. Patients currently taking this medication should contact their pharmacist or doctor.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0097-2025·2024-12-11
Diltiazem extended-release capsules recalled for manufacturing impurity
Glenmark Pharmaceuticals is recalling 4,704 bottles of Diltiazem Hydrochloride extended-release capsules 90mg due to manufacturing contamination with an impurity above FDA limits. Two lot numbers distributed nationwide are affected.
Product
DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0246-2025·2024-12-11
Albertsons Green Chili Chicken Enchiladas Recalled for Listeria Contamination
Albertsons is recalling two green chicken enchilada meal kit products due to Listeria monocytogenes contamination in the cooked chicken. Affected products were distributed across 20 states with sell-through dates up to October 13, 2024.
Product
(1) READY MEALS GREEN CHILI CHICKEN ENCHILADAS SS COLD (UPC 21291600000) (2) GREEN CHICKEN ENCHILADAS 6 CT SS COLD (UPC 27163500000)
Category
Food
Distribution
21 states
HighFDA (Devices)·Z-0583-2025·2024-12-11
Spectral CT Devices Pose Collision and Misdiagnosis Software Risks
Philips Spectral CT and Spectral CT Plus devices may fail to update plan positioning during interventional procedures, creating collision risks to operators and patients. A software defect may also assign incorrect patient IDs, potentially causing misdiagnosis.
Product
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0627-2025·2024-12-11
Medline Medical Device Kits Recalled Due to Defective SafeAir Component
Medline is recalling 980 units of medical convenience kits manufactured using SafeAir Smoke Evacuation Pencil components that Stryker previously recalled. The kits were distributed nationwide.
Product
MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYNJ0842590G; 3) TREATMENT ROOM PACK, REF DYNJ41473G; 4) TREATMENT ROOM PACK, REF DYNJ41473I; 5) BREAST BIOPSY PACK, REF DYNJ44148G; 6) PRX BREAST PACK, RE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0108-2025·2024-12-11
Cinacalcet Tablets Recalled for Excess Nitrosamine Impurity
AvKARE is recalling Cinacalcet Tablets 30 mg due to nitrosamine impurity levels exceeding safe limits. Affected bottles nationwide should not be used.
Product
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0618-2025·2024-12-11
McKesson Calcium Alginate Wound Dressing Recalled for Sterile Barrier Defect
McKesson Calcium Alginate Dressing Model 3562 is recalled because defects in the primary packaging pouch compromise the sterile barrier. Lot number W00070426 affects approximately 8,000 boxes distributed across Illinois, Texas, and Virginia.
Product
McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0629-2025·2024-12-11
MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Pencil Component
MEDLINE is recalling 102 varieties of surgical convenience kits containing SafeAir Smoke Evacuation Pencils that have been recalled by manufacturer Stryker. The nationwide recall affects 24,754 units.
Product
MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259N; 5) HEAD AND NECK, REF CDS984259O; 6) HEAD & NECK CDS, REF CDS984282L; 7) T & A, REF CDS984895I; 8) T & A,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0630-2025·2024-12-11
Medline Surgical Kits Recalled Due to Defective Smoke Evacuation Component
Medline is recalling 167,074 surgical convenience kits nationwide containing SafeAir Smoke Evacuation Pencils previously recalled by manufacturer Stryker for use in various surgical procedures.
Product
MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS760057L; 4) MAJOR LAPAROTOMY CDS, REF CDS860015W; 5) MINOR LAPAROTOMY CDS, REF CDS860016P; 6) MINOR LAPAROTOMY CDS, REF CDS860016Q; 7) MINOR LAPAROTOMY CDS, REF
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·24V922000·2024-12-11
Great Dane Recalls 2025 Champion Trailers Due to Missing Kingpin Welds
Great Dane is recalling 2025 Champion Dry Freight trailers because missing kingpin welds may prevent secure connection, increasing crash risk.
Product
GREAT DANE — GREAT DANE CHAMPION
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·24V923000·2024-12-11
Suzuki Recalls 2023-2025 Burgman 400 Scooters for Fuel Leak Risk
Suzuki is recalling 2023-2025 Burgman 400 scooters because a fuel supply hose may contact a vapor hose, causing fuel leaks that increase fire risk.
Product
SUZUKI — SUZUKI AN400
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0584-2025·2024-12-11
BD EpiCenter Medical Device Software Service Credentials Accessed by Unauthorized Party
BD EpiCenter software service credentials were accessed by an unauthorized actor. Until credentials are updated, there is risk of unauthorized access to the software and associated data.
Product
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·24V921000·2024-12-11
Gillig Recalls 2023 Low Floor Buses Due to Odometer Defect
Gillig is recalling 2023 Low Floor diesel-hybrid transit buses because the odometer fails to display mileage in electric mode, potentially delaying critical maintenance.
Product
GILLIG — GILLIG LOW FLOOR
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0106-2025·2024-12-11
Duloxetine Delayed-Release Capsules Recalled for N-Nitroso Impurity Above Limits
Rising Pharma is recalling 122,925 bottles of Duloxetine 30 mg capsules nationwide due to a manufacturing deviation: the presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Product
Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0632-2025·2024-12-11
MEDLINE Port Insertion Pack Recalled for Defective Component
Medline is recalling 44 PORT INSERTION PACK kits nationwide. These kits contain SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.
Product
MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0107-2025·2024-12-11
Duloxetine DR Capsules recalled nationwide for nitrosamine impurity
Rising Pharmaceuticals is recalling Duloxetine DR Capsules 60 mg nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA interim limits. The recall affects approximately 233,003 bottles.
Product
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0643-2025·2024-12-11
MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Component
MEDLINE is recalling surgical convenience kits nationwide because they contain smoke evacuation pencil components from a Stryker product that was previously recalled. The affected kits are used in robotic and laparoscopic surgical procedures.
Product
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P; 5) ROBOTIC, REF CDS984262N; 6) GYN LAPAROSCOPY, REF CDS984900M; 7) GYN LAP
Category
Medical Device
Distribution
Distributed nationwide