The Recall Desk

State

Massachusetts product recalls

20,083 recalls have nationwide distribution and so reach Massachusetts. 0 additional recalls listed Massachusetts specifically in their distribution scope.

About recalls in Massachusetts

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Massachusetts consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

6326–6350 of 20083

  • HighFDA (Devices)·Z-0962-2025·2025-01-22

    Olympus LithoCrushV Mechanical Lithotriptor Recalled for Distal Tip Tearing Risk

    Olympus Corporation recalls the LithoCrushV Single Use Mechanical Lithotriptor due to potential distal tip tearing during endoscopic procedures. The FDA Class II recall affects 989 units distributed nationwide.

    Product
    LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0930-2025·2025-01-22

    Medical procedure kit recall due to sterile barrier packaging breach risk

    Sklar Instruments is recalling ECONO STERILE nasal procedure kits due to packaging issues that may compromise sterility. The recall affects 175 units distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0925-2025·2025-01-22

    ECONO STERILE ear cleaning kits recalled for packaging sterile barrier issues

    Sklar Instruments is recalling ECONO STERILE medical procedure kits for ear cleaning due to packaging issues that may result in a breach of the sterile barrier. The kits have been distributed nationwide.

    Product
    ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273; 2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-2283; for ear cleaning
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0946-2025·2025-01-22

    Gynecological dilator kits recalled for potential sterile barrier compromise

    Sklar Instruments is recalling ECONO STERILE gynecological dilator kits nationwide due to packaging issues that may breach the sterile barrier, potentially affecting product safety.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO STERILE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0956-2025·2025-01-22

    Murata Vios Cardiac Monitor Model 2050 Displays Distorted and Flickering Waveforms

    The muRata Vios Monitoring System Model 2050 central station monitor can display distorted and flickering ECG waveforms and vital signs. The issue affects only the central station display, not the bedside monitor or patient monitoring accuracy.

    Product
    muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0919-2025·2025-01-22

    Bone Graft Putty Recalled for Polymer Hydration Issue Affecting Handling

    IsoTis OrthoBiologics is recalling OsteoCove Putty and Cove Putty due to a polymer hydration defect that reduces product cohesiveness and moldability.

    Product
    OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0932-2025·2025-01-22

    ECONO STERILE Nail Nippers and Tissue Nippers Recalled for Sterile Barrier Issues

    Sklar Instruments is recalling ECONO STERILE nail nipper and tissue nipper kits due to packaging defects that may compromise their sterile barrier. The affected kits were distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666; 4) ECONO STER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0948-2025·2025-01-22

    Sklar Instruments IUD Extractor Kits Recalled for Sterile Barrier Packaging Issues

    Sklar Instruments is recalling ECONO STERILE IUD Extractor kits (Model 96-4146A) due to packaging defects that may compromise the sterile barrier. Nationwide distribution.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0933-2025·2025-01-22

    Sklar Instruments Recalls ECONO STERILE Surgical Retractors Due to Packaging Issues

    Sklar Instruments is recalling 1,050 ECONO STERILE surgical retractors nationwide due to packaging defects that may compromise sterility. The affected kits have potential breaches in their sterile barriers.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3) ECONO STERILE SENN RETR DE BL 6.25"STRLCS/25, Model Number 96-2267; 4) ECONO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0923-2025·2025-01-22

    Tenaculum Forceps for da Vinci Surgical Systems Recalled Due to Pitch Cable Failures

    Intuitive Surgical is recalling 8MM Tenaculum Forceps used with da Vinci X/Xi Surgical Systems due to pitch cable failures. These instruments are used for tissue manipulation and retraction during surgical procedures.

    Product
    8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0904-2025·2025-01-22

    Medtronic NanoCross Elite PTA Catheter Recall Due to Balloon Deflation

    Medtronic's NanoCross Elite PTA catheters in certain lots may not deflate properly during use. The FDA is recalling 5,189 units due to potential in-vivo balloon deflation issues.

    Product
    Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0947-2025·2025-01-22

    ECONO STERILE Gynecologic Biopsy Kits Recalled for Sterile Packaging Issues

    Sklar Instruments is recalling ECONO STERILE gynecologic biopsy procedure kits because of packaging issues that may breach the sterile barrier.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynecologic biopsy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0926-2025·2025-01-22

    ECONO STERILE Medical Procedure Kits Recalled for Packaging Defects

    Sklar Instruments is recalling ECONO STERILE medical procedure kits due to packaging issues that may compromise the sterile barrier and allow contamination.

    Product
    ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)
    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-0959-2025·2025-01-22

    Change Healthcare Cardiology Software Defect May Cause Incorrect Medication Administration

    A software defect in Change Healthcare's Cardiology Hemodynamics software may cause clinicians to administer incorrect medications. The defect affects an autosave mechanism and has been distributed nationwide and internationally.

    Product
    Change Healthcare Cardiology Hemodynamics software
    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-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 (Drugs)·D-0203-2025·2025-01-22

    Prescription Drug Cardura Recalled for Specification Failures in Manufacturing

    Viatris Inc is recalling Cardura (doxazosin mesylate) XL 8 mg tablets due to failed stability testing revealing out-of-specification impurity levels. Approximately 1,215 bottles distributed nationwide are affected.

    Product
    CARDURA — CARDURA (DOXAZOSIN MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-0934-2025·2025-01-22

    ECONO STERILE Dental Cement Spatula Kits Recalled for Packaging Issues

    Sklar Instruments is recalling ECONO STERILE dental cement spatulas (Model 96-2245M) due to packaging defects that may compromise the sterile barrier. The product was distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M, mixing utensil, dental
    Category
    Medical Device
    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-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 (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 (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
  • ModerateFDA (Devices)·Z-0921-2025·2025-01-22

    DRG:HYBRiD-XL Insulin Device Recalled for Calibration Failures

    DRG International is recalling the DRG:HYBRiD-XL Insulin device (Model HYE-5361) due to calibration failures and out-of-specification controls that may delay assay results.

    Product
    DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
    Category
    Medical Device
    Distribution
    Distributed nationwide