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.

8726–8750 of 81203

  • SevereFDA (Devices)·Z-0662-2025·2024-12-25

    Exacta External Drainage System Stopcocks May Leak or Crack

    Medtronic Neurosurgery is recalling Exacta External Drainage and Monitoring Systems worldwide due to complaints of cracking and leaking stopcocks. These components control cerebrospinal fluid drainage and intracranial pressure monitoring.

    Product
    Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0660-2025·2024-12-25

    Optikon Bipolar Pencil surgical tool recalled for tube failure risk

    FDA recalls Kirwan Surgical's Optikon Bipolar Pencil surgical instruments due to risk that the outer stainless-steel tube may break or detach during use. The recalled devices were distributed worldwide.

    Product
    Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0144-2025·2024-12-25

    Pearson Quality Topical Anesthetic Gel Recalled Due to Manufacturing Defect

    Keystone Industries is recalling Pearson Quality Topical Anesthetic Gel (20% Benzocaine) due to manufacturing equipment defects that could allow product contamination. The affected lot was inadvertently shipped despite quality control rejection.

    Product
    Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0138-2025·2024-12-25

    Topical Anesthetic Gel Recalled for Manufacturing Equipment Defect

    Keystone Industries is recalling Benzocaine 20% topical anesthetic gel due to scratches in the manufacturing mixing vessel. Despite Quality Assurance rejection, the product was inadvertently shipped to customers.

    Product
    M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0693-2025·2024-12-25

    Bronchoscopic system may lose power due to defective component

    A defective power component in Noah Medical's Galaxy System bronchoscope may cause sudden power loss during procedures, potentially leading to lung injury or pneumotharax.

    Product
    Galaxy System (GAL-001)
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0680-2025·2024-12-25

    Laser Atherectomy Catheter Recalled for Marker Band Detachment Risk

    Spectranetics is recalling the Turbo Elite Laser Atherectomy Catheter because the marker band can detach from the catheter tip and remain in the patient. This defect was identified through customer complaints.

    Product
    Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 / 989930000531 / 1.4 mm OTW 417-152 / 989930000551 / 1.7 mm OTW 420-006 / 989930000571 / 2.0 mm OTW 423-001 / 989930000591 / 2.3 mm OTW 425-011 / 989930000601 / 2.5 mm OTW 423-1
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Drugs)·D-0146-2025·2024-12-25

    Quala Dental Topical Anesthetic Gel Recalled for Manufacturing Equipment Defect

    Quala Dental Products topical anesthetic gel (20% benzocaine) is recalled due to manufacturing equipment defects. The bulk product was inadvertently released despite Quality Unit rejection after inspection found scratches on the mixing vessel.

    Product
    Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 37086, www.quala.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0688-2025·2024-12-25

    K-Systems G85 Mini Incubator May Exceed Desired Temperature

    CooperSurgical recalls 37 K-Systems G85 Mini Incubators because the device warming surfaces may exceed the desired set temperature. The unit alarms when this occurs, but affected serial numbers require verification.

    Product
    Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Drugs)·D-0153-2025·2024-12-25

    OTC Ophthalmic Solution Recalled for Lack of Sterility Assurance

    REGENER-EYES ophthalmic solution is being recalled nationwide due to lack of sterility assurance. Consumers should stop using affected lots immediately.

    Product
    PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-003-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0152-2025·2024-12-25

    Ophthalmic solution recalled for lack of sterility assurance

    Regener-Eyes ophthalmic solution is being recalled due to lack of sterility assurance. Approximately 170,812 bottles distributed nationwide are affected.

    Product
    LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distributed by: Regener-Eyes, Tampa, FL; Manufactured by: Regenerative Processing Plant, LLC, 34176 US HWY 19N, FL, NDC 82305-006-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0285-2025·2024-12-25

    Impossible Spicy Ground Sausage Recalled for Potential Metal Contamination

    Impossible Foods is recalling Impossible Spicy Ground Sausage due to potential metal pieces in the product. The recall affects 32,536 cases distributed nationwide with use-by dates between June 28, 2025 and January 28, 2026.

    Product
    Impossible Spicy Ground Sausage Meat from plants 14oz chub, UPC 8 16697 02109 5; 8 retail chubs per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0710-2025·2024-12-25

    Medical imaging software recall for incorrect DICOM orientation labels

    Mint Lesion software versions 3.10.0 and 3.10.1 may display incorrect orientation labels for certain DICOM medical images. The defect affects 18 units distributed across the US and internationally.

    Product
    mint Lesion, Software Versions: 3.10.0 and 3.10.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0692-2025·2024-12-25

    K-Systems Incubator Device Recall: Temperature May Exceed Desired Setting

    CooperSurgical is recalling 34 K-Systems incubator devices used in assisted reproduction procedures. The warming surfaces may exceed the desired set temperature, though the device will alarm if this occurs.

    Product
    Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g.,
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-0286-2025·2024-12-25

    Food-Grade Salt Products Recalled for Foreign Material Contamination

    Compass Minerals America Inc. is recalling approximately 67 metric tons of food-grade salt products due to foreign material contamination. The voluntary recall affects products distributed in Massachusetts, Indiana, Wisconsin, and Canada.

    Product
    Bulk salt product shipped in 1 metric ton tote; 50lb bag Special Purity Granulated Food-Grade Salt with UPC 041582150158; 44lb bag sifto Hy Grade Food Grade Salt, Compass Minerals America Inc. 9900 West 109th Street Overland Park, KS 99219
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0686-2025·2024-12-25

    Philips Access Point Software Issue Risks Patient Data Loss

    Philips Smart-Hopping 2.0 Access Points may reset after 82 days, risking loss of patient data and network disconnections. No injuries have been reported.

    Product
    Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0151-2025·2024-12-25

    VCF Contraceptive Pre-filled Applicators Recalled for Out-of-Specification Active Ingredient

    Apothecus Pharmaceutical recalls 33,659 boxes of VCF nonoxynol-9 contraceptive gel nationwide due to out-of-specification active ingredient assay from manufacturing deviations. No illnesses reported.

    Product
    VCF CONTRACEPTIVE PRE-FILLED APPLICATORS — VCF CONTRACEPTIVE PRE-FILLED APPLICATORS (NONOXYNOL-9)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0689-2025·2024-12-25

    K-Systems T47 Warming Plate may exceed desired temperatures

    The K-Systems T47 Warming Plate has a temperature control defect where warming surfaces may exceed desired set temperatures. CooperSurgical is recalling 22 affected units distributed to fertility clinics.

    Product
    Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Drugs)·D-0142-2025·2024-12-25

    FDA Recalls Health-Tec Benzocaine Topical Anesthetic Due to Manufacturing Defect

    Keystone Industries recalls Health-Tec Topical Anesthetic (Benzocaine 20%) lot BNZ-001646 due to manufacturing defects. Scratches found in the mixing vessel caused product rejection designation, but product was inadvertently shipped.

    Product
    HEALTH-TEC TOPICAL ANESTHETIC — HEALTH-TEC TOPICAL ANESTHETIC (BENZOCAINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0690-2025·2024-12-25

    K-Systems T47 Warming Plate May Exceed Set Temperatures

    CooperSurgical recalls K-Systems T47 Warming Plates because temperature may exceed the desired set value, potentially affecting biological materials. The device alarms appropriately when this occurs.

    Product
    Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0657-2025·2024-12-25

    Ambler Surgical Bipolar Pencil recalled for outer tube structural failure

    Kirwan Surgical Products is recalling the Ambler Surgical Bipolar Pencil 25 Gauge Straight (Model PD7226) because the outer stainless-steel tube may break or detach during use. 4,470 units worldwide are affected.

    Product
    Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area durin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0709-2025·2024-12-25

    Medical Imaging Software Recall: mint Lesion Orientation Display Malfunction

    Mint Medical is recalling mint Lesion software versions 3.9.0–3.9.5 due to a malfunction that may display incorrect orientation labels for certain medical images. 65 units were distributed in the US and internationally.

    Product
    mint Lesion, Software Versions: 3.9.0 through 3.9.5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0140-2025·2024-12-25

    Dental City Topical Anesthetic Gel Recalled Due to Manufacturing Defect

    Dental City Topical Anesthetic Gel (Benzocaine 20%) is recalled because the product was released and distributed despite failing quality inspection. Scratches were found in the mixing vessel during routine inspection.

    Product
    Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental City, Green Bay, WI 54311, dentalcity.com.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0687-2025·2024-12-25

    K-Systems G73 Dry Bath Incubator may exceed target temperature

    CooperSurgical is recalling K-Systems G73 Dry Bath Incubators because warming surfaces may exceed the desired set temperature. The device alarms when this occurs.

    Product
    Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at c
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Drugs)·D-0139-2025·2024-12-25

    Primo Topical Anesthetic Gel Recalled for Manufacturing Defect

    Primo Topical Anesthetic Gel (Benzocaine 20%) is recalled due to manufacturing defect. A Quality Unit inspection found scratches in the mixing vessel, causing inadvertent release of product that should have been rejected.

    Product
    Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022.
    Category
    Drug
    Distribution
    Distributed nationwide