The Recall Desk

State

Massachusetts product recalls

72,992 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 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

8501–8525 of 81203

  • HighFDA (Devices)·Z-0845-2025·2025-01-22

    X-Flow Prostatectomy Catheter Recalled for Possible Sterility Defect

    Coloplast is recalling 36,369 X-Flow prostatectomy catheters due to a possible sterility issue detected at its manufacturing facility.

    Product
    X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0961-2025·2025-01-22

    VerifyNow P2Y12 Platelet Reactivity Test distributed without FDA market clearance

    Accriva Diagnostics distributed the VerifyNow P2Y12 Platelet Reactivity Test (Lot WL1145) without required FDA clearance. Healthcare professionals could use the unapproved test to guide treatment decisions for P2Y12 inhibitor therapy.

    Product
    VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0952-2025·2025-01-22

    Orthopedic Surgery Kits Recalled for Potential Sterile Barrier Packaging Defects

    Sklar Instruments is recalling ECONO STERILE LEMPERT BONE RONG orthopedic surgery kits due to packaging defects that may compromise sterility. The affected kits (Model 96-4780A, Lot HSI) were distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A; orthopedic surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0397-2025·2025-01-22

    Yu Yee Five Spice Powder Recalled for High Lead Levels

    Summit Import Corporation is recalling Yu Yee Five Spice Powder due to high levels of lead detected in testing. Consumers should discontinue use and contact a healthcare provider with concerns.

    Product
    Yu Yee, Five Spice Powder,1.76oz
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-0918-2025·2025-01-22

    Portrait Core Services Software Loss of Patient Monitoring After 425 Days

    A software issue in GE's Portrait Core Services medical device software causes loss of patient monitoring capability in the Portrait Central Viewer Application after 425 days of continuous operation.

    Product
    Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0909-2025·2025-01-22

    Surgical Kit Recall: Potential Endotoxin Contamination in Cardinal Health Presource Kits

    Cardinal Health recalls Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Affected units were distributed in the US, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHHA:; 3 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERM5:; 4 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMO:; 5 ) RIVERSIDE S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0851-2025·2025-01-22

    Intuitive Surgical Micro Forceps Recalled Due to Grip Cable Defects

    Intuitive Surgical is recalling 8MM Black Diamond Micro Forceps (Model 470033) due to complaints of frayed or broken grip cables. The defect affects 1,111 units distributed nationwide and internationally.

    Product
    8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0937-2025·2025-01-22

    Sklar Instruments Recalls ECONO STERILE Surgical Scalpel Handles for Sterile Barrier Risk

    Sklar Instruments recalls ECONO STERILE SCALPEL HDL #3 surgical handles due to packaging issues that may compromise the sterile barrier. The 150-unit recall affects units distributed nationwide with lot code SK-125.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0878-2025·2025-01-22

    Fenestrated Bipolar Forceps Recalled Due to Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 147,006 units of 8MM Fenestrated Bipolar Forceps due to increased complaints of frayed or broken grip cables, which could impair surgical control.

    Product
    8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0863-2025·2025-01-22

    8MM Dual Blade Retractors recalled for frayed or broken grip cables

    Intuitive Surgical is recalling 8MM Dual Blade Retractors due to increased complaints of frayed or broken grip cables. This defect affects 783 reusable surgical instruments distributed in the U.S. and internationally.

    Product
    8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0936-2025·2025-01-22

    ECONO STERILE Medical Procedure Kits Recalled for Sterile Barrier Compromise

    Sklar Instruments recalls ECONO STERILE medical procedure kits (300 units nationwide) due to packaging issues that may compromise sterile barrier integrity.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAUS TWL CLP STER 5.25 25, Model Number 96-2636; general purpose clips
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0938-2025·2025-01-22

    Surgical Suction Tubes Recalled for Sterile Packaging Defects

    ECONO STERILE suction tubes and surgical instruments (150 units, nationwide) are recalled for packaging defects that may breach the sterile barrier and create infection risk during medical procedures.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25, Model Number 96-5434; 4) ECONO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2025·2025-01-22

    Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health is recalling 512,786 Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to the US, Canada, and Saudi Arabia.

    Product
    Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , Catalog Number: PE23NSMEA; 2 ) KIT, NASAL , Catalog Number: PE23NSMEC; 3 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number: PE23SENLA; 4 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2025·2025-01-22

    Intuitive Surgical Fenestrated Grasper Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling its 8MM Tip-Up Fenestrated Grasper due to frayed or broken grip cables on reusable surgical instruments. The defect affects multiple batch numbers produced between 2023 and 2024.

    Product
    8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0917-2025·2025-01-22

    Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination

    Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Endotoxins could pose a risk if contaminated components are used in sterile surgical procedures.

    Product
    Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH1; 3) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH2; 4) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH3; 5) KIT,H N FREE FLAP , Catalog Numb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0196-2025·2025-01-22

    Acetaminophen Extra Strength tablets recalled for incorrect imprinting

    Akron Pharma is recalling 1,232 bottles of Acetaminophen Extra Strength tablets due to incorrect imprinting on the tablets. The product identification may be wrong on the affected tablets.

    Product
    Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., 373 US RT 46 W Building E, Suite 117, Fairfield, NJ 07034, NDC 71399-8022-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0942-2025·2025-01-22

    Sklar Instruments ECONO STERILE Blackhead Extractor Kits Recall

    Sklar Instruments is recalling ECONO STERILE blackhead extractor kits (Model 96-2395M) due to packaging issues that may compromise the sterile barrier. The kits were distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0204-2025·2025-01-22

    Prescription Drug Cardura XL Recalled for Out-of-Specification Impurity

    Viatris is recalling Cardura XL (doxazosin) 4 mg extended-release tablets nationwide due to out-of-specification impurity results detected during stability testing.

    Product
    CARDURA — CARDURA (DOXAZOSIN MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0197-2025·2025-01-22

    Diphenhydramine HCl Capsules Recalled Due to Wrong Imprinting

    Akron Pharma is recalling Diphenhydramine HCl 25 mg capsules nationwide because the capsules are imprinted with incorrect identification. Consumers should stop using the affected product.

    Product
    Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8028-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0401-2025·2025-01-22

    Eclectic Herb Vitamin Blend Dietary Supplement Recalled for Label Errors

    Eclectic Herb Vitamin Herb Blend dietary supplement is recalled because the Supplement Facts panel contains incorrect ingredient names and quantities. Consumers should check affected lot numbers.

    Product
    Eclectic Herb Vitamin Herb Blend vita biotic dietary supplement, 750mg, 150 capsules per plastic bottle, UPC 0 23363 52002 2. Eclectic Institute, Inc. 755 NE 6th Street Gresham, OR 97030. The affected label declared "Oregon Grape 190mg ***Oregon Grape 97mg***Cayenne Root (Allium
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0919-2025·2025-01-22

    OsteoCove and Cove Putty bone void fillers recalled due to hydration defect

    IsoTis OrthoBiologics is recalling OsteoCove Putty and Cove Putty bone graft materials due to a hydration issue that makes the product less cohesive and moldable than intended.

    Product
    OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0195-2025·2025-01-22

    Acetaminophen 325 mg tablets recalled for incorrect imprinting

    Akron Pharma is recalling 14,825 bottles of Acetaminophen 325 mg tablets due to incorrect tablet imprinting affecting lots KDT0124004, KDT0124005, and KDT0124006 (expiring August 31, 2026). No illnesses have been reported.

    Product
    Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma, Manufactured for: Akron Pharma Inc., Fairfield, NJ 07034, NDC 71399-8014-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0955-2025·2025-01-22

    Demineralized Bone Matrix Putty Recalled for Incorrect Outer Box Expiration Date

    IsoTis OrthoBiologics recalls OsteoSurge 100 Demineralized Bone Matrix Putty due to incorrect expiration dates on outer packaging. The outer box date does not match the correct date on the inner tray.

    Product
    OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0193-2025·2025-01-22

    Acetaminophen Extra Strength tablets recalled for incorrect product imprint identification

    Akron Pharma recalls 768 bottles of Acetaminophen Extra Strength 500 mg due to incorrect identification imprinted on the tablets nationwide.

    Product
    Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01.
    Category
    Drug
    Distribution
    Distributed nationwide