The Recall Desk

State

Massachusetts product recalls

73,381 recalls have nationwide distribution and so reach Massachusetts. 8,241 additional recalls listed Massachusetts specifically in their distribution scope.

What the numbers show

Total
8,241
Critical
1,181
Severe
2,353
Most recent
2026-10-07

Of the 8,241 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 2,353 (29%) are Severe.

Which agencies issued them

These figures cover only the 8,241 recalls whose distribution notice names Massachusetts specifically. The 73,381 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

19201–19225 of 81622

  • CriticalFDA (Devices)·Z-0886-2023·2023-01-25

    Cardiosave IABP may shut down unexpectedly due to blood contamination

    The Cardiosave Rescue Intra-Aortic Balloon Pump may shut down unexpectedly if blood enters the device through a compromised balloon catheter. Approximately 46 units have been distributed worldwide.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0885-2023·2023-01-25

    Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly

    The Cardiosave Hybrid Intra-Aortic Balloon Pump may shut down unexpectedly when blood enters the device through a compromised balloon catheter during use.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0131-2023·2023-01-25

    Daptomycin for Injection Recalled Due to Incorrect Labeling Dosage

    Accord Healthcare is recalling Daptomycin for Injection labeled as 350 mg/vial but containing 500 mg/vial vials. The labeling error poses a dosing risk to patients.

    Product
    Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0926-2023·2023-01-25

    Medical device controller software update addresses critical failure

    Cardiac Assist is issuing a software update for LifeSPARC Controller units that may experience critical failure causing the system to freeze, crash, or lose display functionality. Affected units are identified by specific serial numbers.

    Product
    SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V026000·2023-01-25

    2022-2023 BMW i4 and iX Vehicles Lack Pedestrian Warning Sounds

    BMW is recalling 2022-2023 i4 eDrive40 and iX xDrive50 electric vehicles because the external pedestrian warning sound system may fail during start-up. Pedestrians could be unaware of approaching vehicles, increasing injury risk.

    Product
    BMW — BMW IX, I4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Issues

    Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. No injuries have been reported.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2215
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0987-2023·2023-01-25

    Cardinal Health surgical drain recalled for performance and safety defects

    Cardinal Health is recalling approximately 24,963 Jackson-Pratt Channel Drains due to multiple performance defects including broken tips, dull insertion tools, reduced flexibility, and visibility issues. Units were distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2229
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0968-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains recalled for performance defects

    Cardinal Health is recalling 4,111 Jackson-Pratt Channel Drains (10 Fr) due to multiple performance issues including dull trocars, broken tips, reduced flexibility, and lack of radiopacity that may affect device function.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0133-2023·2023-01-25

    Drug Recall: Artificial Tears Eye Ointment Due to Manufacturing Deviations

    Akorn, Inc. is recalling Artificial Tears Ointment (1.16 million tubes nationwide) due to manufacturing practice deviations. The firm voluntarily initiated this recall.

    Product
    Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0139-2023·2023-01-25

    FDA Recalls Nationwide Supply of Erythromycin Ophthalmic Ointment for Manufacturing Deviations

    Akorn, Inc. is recalling 36,455 cartons of Erythromycin Ophthalmic Ointment USP 0.5% nationwide due to manufacturing process deviations. The company voluntarily initiated this Class II recall.

    Product
    Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0129-2023·2023-01-25

    Local anesthetic Sensorcaine vials recalled for subpotent epinephrine

    Fresenius Kabi is recalling Sensorcaine-MPF local anesthetic vials due to subpotent epinephrine levels. The affected batch (31,600 vials) was distributed nationwide.

    Product
    SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0970-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance defects including dull trocars, broken tips, and radiopacity issues. 921 units affected worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2189
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0979-2023·2023-01-25

    Cardinal Health Jackson-Pratt Drain Recalled for Multiple Performance Issues

    Cardinal Health is recalling Jackson-Pratt Channel Drains due to multiple performance issues including dull trocars, lack of radiopacity, reduced flexibility, and broken tips. The affected devices were distributed worldwide.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2216
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0135-2023·2023-01-25

    Betaxolol ophthalmic solution recalled for manufacturing process violations

    Akorn, Inc. is voluntarily recalling Betaxolol ophthalmic solution (6,273 bottles, lot 1A08A, exp. 12/31/2022) due to manufacturing deviations. Consumers should consult their healthcare provider.

    Product
    Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-705-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0967-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains Recalled for Performance Defects

    Cardinal Health is recalling 1,150 Jackson-Pratt Channel Drains due to multiple performance defects including lack of radiopacity, dull trocars, reduced flexibility, and broken tips affecting post-surgical wound drainage.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0993-2023·2023-01-25

    Cardinal Health Jackson-Pratt Wound Drain Recall Due to Performance Defects

    Cardinal Health is recalling Jackson-Pratt Channel Drains due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. The worldwide recall affects units used in post-operative wound drainage.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0132-2023·2023-01-25

    FDA Recalls Akorn AK-POLY-BAC Eye Ointment for CGMP Violations

    Akorn Inc. voluntarily recalls 36,025 tubes of AK-POLY-BAC Bacitracin/Polymixin B eye ointment nationwide due to manufacturing process deviations affecting product quality and sterility.

    Product
    AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0128-2023·2023-01-25

    Prescription Anesthetic Drug Recalled for Subpotent Epinephrine Content

    Fresenius Kabi is recalling Sensorcaine anesthetic injections nationwide due to subpotent epinephrine content. Affected batches may not provide adequate anesthesia or hemostasis during procedures.

    Product
    SENSORCAINE — SENSORCAINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0956-2023·2023-01-25

    ARTIS medical imaging systems recalled for mechanical connection failure

    Siemens ARTIS pheno and ARTIS icono imaging systems are recalled because the mechanical connection between the tabletop and table base may fail. The recall affects 550 units distributed worldwide.

    Product
    ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V028000·2023-01-25

    2022 Hyundai Santa Fe Plug-In Hybrid fuel tank defect recall

    Hyundai is recalling certain 2022 Santa Fe Plug-In Hybrid vehicles due to improperly molded fuel tanks that may leak gasoline. A fuel leak in the presence of an ignition source can increase the risk of fire.

    Product
    HYUNDAI — HYUNDAI SANTA FE PLUG-IN HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0998-2023·2023-01-25

    FDA Recalls Thoracic Stent-Graft Systems Over Manufacturing Size Defect

    Bolton Medical has recalled 640 units of RELAY PRO thoracic stent-graft systems worldwide because the products may be shorter than their packaging indicates.

    Product
    RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0984-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains recalled for multiple performance defects

    Cardinal Health is recalling 2,277 Jackson-Pratt Channel Drains due to performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken tips. These defects may affect the drain's function and clinical performance.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2023·2023-01-25

    Cardinal Health Jackson-Pratt Surgical Drains Recalled for Multiple Defects

    Cardinal Health recalls Jackson-Pratt Channel Drains due to reported defects including non-visibility on imaging, dull insertion trocars, reduced flexibility, and broken drain tips.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-2292
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0980-2023·2023-01-25

    Cardinal Health Jackson-Pratt Channel Drains Recalled for Multiple Performance Defects

    Cardinal Health is recalling 750 units of Jackson-Pratt Channel Drains (10 mm) due to multiple performance issues including broken drain tips, lack of radiopacity, dull trocars, and reduced flexibility that could affect surgical outcomes.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2217
    Category
    Medical Device
    Distribution
    Distributed nationwide