The Recall Desk

State

Massachusetts product recalls

73,824 recalls have nationwide distribution and so reach Massachusetts. 8,252 additional recalls listed Massachusetts specifically in their distribution scope.

What the numbers show

Total
8,252
Critical
1,179
Severe
2,360
Most recent
2026-11-04

Of the 8,252 recalls naming Massachusetts we have scored against our rubric, 1,179 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,360 (29%) are Severe.

These figures cover only the 8,252 recalls whose distribution notice names Massachusetts specifically. The 73,824 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

44276–44300 of 82076

  • SevereFDA (Drugs)·D-0452-2018·2018-02-28

    Pharmedium Recalls Ketamine HCl Injection Due to Sterility Assurance Concerns

    Pharmedium Services, LLC is recalling all lots of Ketamine HCl Injection because of a lack of sterility assurance. The recall covers all strengths, doses, and packaging distributed nationwide.

    Product
    Ketamine HCl Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0640-2018·2018-02-28

    GastriSail Gastric Positioning Device Recalled Due to Perforation Reports

    FDA is recalling 17,271 units of the GastriSail Gastric Positioning Device due to reports of gastric or esophageal perforation during surgical procedures.

    Product
    GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0440-2018·2018-02-28

    Pharmedium Recalls Potassium Chloride Infusions Due to Sterility Concerns

    Pharmedium Services, LLC is recalling all lots of Potassium Chloride in 0.9% Sodium Chloride due to a lack of sterility assurance.

    Product
    Potassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0639-2018·2018-02-28

    Zimmer Biomet Recalls ROSA Spine Stereotaxic Instrument Due to Positioning Error

    Zimmer Biomet is recalling one ROSA Spine 1.0.2 Stereotaxic instrument because the robot arm may move to the wrong position during surgery.

    Product
    ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Drugs)·D-0430-2018·2018-02-28

    Pharmedium Recalls Fentanyl and Ropivacaine Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Fentanyl Citrate and Ropivacaine HCl injections because of a lack of sterility assurance. The recall covers all lots remaining within their expiry dates nationwide.

    Product
    Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0450-2018·2018-02-28

    Pharmedium Recalls Fentanyl Citrate Injection Due to Sterility Concerns

    Pharmedium Services, LLC is recalling Fentanyl Citrate Injection in all strengths and packaging due to a lack of sterility assurance.

    Product
    Fentanyl Citrate Injection in all strengths, all doses, and all packaging.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0584-2018·2018-02-28

    Medtronic Viva CRT-D Recall for Possible Prevention of Therapy

    Medtronic is recalling 951 Viva CRT-D devices due to a potential issue that may prevent high and low voltage therapy.

    Product
    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Viva. Labeled as the following: a. Viva Quad S CRT-D DF4 (Product No. DTBB1QQ); b. Viva Quad XT CRT-D DF4 (Product No. DTBA1QQ); c. Viva S CRT-D DF1 (Product No. DTBB1D1); d. Viva XT CRT-D DF1 (Product No.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0650-2018·2018-02-28

    Arrow International Recalls Multi Lumen Central Venous Catheterization Kits

    Arrow International is recalling 5,926 Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.

    Product
    Multi Lumen Central Venous Catheterization Kit; Product Code: ASK-12703-HH2; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2018·2018-02-28

    Arrow International Recalls Multi Lumen Central Venous Catheterization Kits

    Arrow International Inc is recalling specific lots of AGB+ Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.

    Product
    AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0815-2018·2018-02-28

    Flexfrost Protein Ice Cream Recalled for Insufficient Pasteurization Monitoring

    Flexfrost is recalling 1200/4 oz cups of Chocolate Protein Ice Cream due to insufficient pasteurization monitoring measures identified by the Ohio Department of Agriculture.

    Product
    Flexfrost Protein Ice Cream Chocolate Flexfrost L.L.C. 622 RT 10 Whippany, NJ 07981
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0685-2018·2018-02-28

    Boston Scientific Recalls Innova Self-Expanding Stent Systems Due to Release Defect

    Boston Scientific is recalling 22,916 units of the Innova Self-Expanding Stent System because the stent may not fully release from the delivery system.

    Product
    Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0686-2018·2018-02-28

    Boston Scientific Recalls Innova Self-Expanding Stent Systems Due to Release Defect

    Boston Scientific is recalling 22,916 Innova Self-Expanding Stent Systems because they may not fully release from the delivery system.

    Product
    Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0675-2018·2018-02-28

    Roche Cobas 8000 Modular Series Software Recall for Incorrect Results Risk

    Roche Diagnostics is recalling 399 Cobas 8000 Modular Series systems due to a software failure that may reset settings to defaults, creating a risk of incorrect test results.

    Product
    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0690-2018·2018-02-28

    Arrow International Recalls PICC Powered by VPS Stylet Kits

    Arrow International is recalling 601 PICC powered by VPS Stylet kits because they may contain an incorrect catheter length.

    Product
    ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0643-2018·2018-02-28

    Pentax Video Duodenoscope Recalled to Mitigate Infection Risk

    Pentax of America Inc is recalling 559 Video Duodenoscopes to replace specific components and update inspection protocols to mitigate the potential risk of infection.

    Product
    Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0687-2018·2018-02-28

    Cosman Medical Recalls Nitinol TC Reusable Electrodes Due to Epoxy Damage

    Cosman Medical is recalling Nitinol TC Reusable Electrodes because epoxy damage after reprocessing can prevent the removal of blood and tissue residuals.

    Product
    Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R*, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M*, 12) TCNK-20-C*, 13) TCN-5, 14) TCNK-20-R*, 15) TCN-5-3M, 16) TCNK-5, 17) TCNK-10…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0657-2018·2018-02-28

    Arrow International Recalls Central Venous Catheterization Kits with Incorrect Guide

    Arrow International is recalling 5,926 Central Venous Catheterization Kits with Blue FlexTip Catheters because they may contain the incorrect Springwire Guide.

    Product
    Central Venous Catheterization Kit with Blue FlexTip Catheter; Product code: AK-04301; Exp. Dates Feb 2018 - Nov 2018
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0528-2018·2018-02-28

    FDA Recalls Testosterone USP Micronized for Prescription Compounding

    American Pharmaceutical Ingredients LLC is recalling Testosterone USP (Micronized) (Yam) for prescription compounding due to CGMP deviations regarding stability data and expiration date controls.

    Product
    Testosterone USP (Micronized) (Yam) for prescription compounding, packaged in a) 25g (NDC 58597-8546-4); b) 100g (NDC 58597-8546-6); c) 500g (NDC 58597-8546-7); d) 1000g (NDC 58597-8546-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0504-2018·2018-02-28

    Levofloxacin Hemihydrate Recalled for Lack of Stability Data

    American Pharmaceutical Ingredients is recalling Levofloxacin Hemihydrate USP for prescription compounding due to missing stability data supporting expiration dates.

    Product
    Levofloxacin Hemihydrate USP for prescription compounding, packaged in a) 100g (NDC 58597-8085-6); b) 1000g (NDC 58597-8085-8), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0536-2018·2018-02-28

    Biotin USP Recalled for Lack of Stability Data and Controls

    American Pharmaceutical Ingredients LLC is recalling Biotin USP for prescription compounding due to CGMP deviations, specifically a lack of stability data and controls to support expiration dates.

    Product
    Biotin USP (Vitamin H) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8142-2); c) 5g (NDC 58597-8142-3); d ) 25g (NDC 58597-8142-4), Rx only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
    Category
    Drug
    Distribution
    Distributed nationwide