The Recall Desk

State

Massachusetts product recalls

73,738 recalls have nationwide distribution and so reach Massachusetts. 8,248 additional recalls listed Massachusetts specifically in their distribution scope.

What the numbers show

Total
8,248
Critical
1,179
Severe
2,356
Most recent
2026-10-28

Of the 8,248 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 2,356 (29%) are Severe.

Which agencies issued them

These figures cover only the 8,248 recalls whose distribution notice names Massachusetts specifically. The 73,738 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

32051–32075 of 81986

  • HighFDA (Devices)·Z-2046-2020·2020-05-27

    Becton Dickinson Recalls BD BBL Gram Crystal Violet Stain Reagent

    Becton Dickinson is recalling BD BBL Gram Crystal Violet stain reagent because it may produce artifacts that look like gram-positive cocci, potentially causing false-positive test results.

    Product
    BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2011-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling Aleutian Lordotic Spreaders because the welded tips may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90113, UDI # 10888857108264, Size 24x10mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2087-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-2042-2020·2020-05-27

    Medline Silicone Foley Catheters Recalled Due to Loose Silicone Particulate

    Medline Industries is recalling 330 units of 100% Silicone Foley Catheters because loose silicone particulate was found on the device shaft.

    Product
    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2014-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Interbody Spacer Systems Lordotic Spreader because the welded tip may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90123, UDI # 10888857108363, Size 24x6mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2037-2020·2020-05-27

    Applied Medical Recalls Stealth Spring Clips for Vascular Occlusion Failure

    Applied Medical Resources Corp is recalling 750 units of Stealth Spring Clips due to a failure to provide sufficient occlusion of vessels during surgery.

    Product
    STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607915110649 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2026-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Welded Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90165, UDI # 10888857108783, Size 28x6mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2062-2020·2020-05-27

    Innovasis Recalls Oryx Cervical Screw Caddies Due to Incorrect Labeling

    Innovasis is recalling six Oryx Cervical Screw Caddies because the labels for fixed and variable rescue screws are swapped. This mislabeling could lead to improper screw installation.

    Product
    Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intended for use in anterior cervical fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20E032000·2020-05-27

    Akron Brass Recalls Wireless Firefighting Monitor Remote Controllers

    Akron Brass is recalling 53 wireless remote controllers for electric firefighting monitors because a disabled sleep mode causes batteries to discharge faster than normal.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2033-2020·2020-05-27

    Advanced Bionics Recalls HiResolution Bionic Ear Systems Due to Fluid Ingress

    Advanced Bionics is recalling HiResolution Bionic Ear Systems because body fluid can enter the device, causing hearing performance degradation.

    Product
    AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2028-2020·2020-05-27

    K2M Recalls Aleutian Lordotic Spreader Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip can break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90169, UDI # 10888857108820, Size 28x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2063-2020·2020-05-27

    Frames Direct Prescription Spectacle Lenses Recalled for Shatter Resistance Failure

    Frames Direct is recalling 87 pairs of prescription spectacle lenses that failed shatter resistance safety specifications, posing a risk of cracked or broken lenses.

    Product
    Frames Direct Prescription Spectacle Lenses included in the frame brands
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-2090-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17)
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-2016-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 10888857108400, Size 24x10mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2036-2020·2020-05-27

    Applied Medical Recalls Stealth Spring Clips for Insufficient Vessel Occlusion

    Applied Medical Resources Corp is recalling 2,240 Stealth Spring Clips because they may fail to sufficiently occlude blood vessels during surgery.

    Product
    STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2071-2020·2020-05-27

    Binding Site Optilite Clinical Chemistry Analyzer Recalled for Software Accuracy Issue

    The Binding Site Group is recalling 36 Optilite Clinical Chemistry Analyzers due to a software issue that may affect result accuracy.

    Product
    The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2032-2020·2020-05-27

    Advanced Bionics Recalls HiResolution Bionic Ear Systems Due to Fluid Entry

    Advanced Bionics is recalling 8,159 HiResolution Bionic Ear Systems because body fluid may enter the device, causing hearing performance degradation.

    Product
    AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2020-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk

    K2M, Inc. is recalling the Aleutian Anatomically Narrow Lordotic Spreader because the welded tip may break off during surgical procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 10888857108622, Size 28x4mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2020·2020-05-27

    K2M Aleutian Lordotic Spreader Recalled for Tip Breakage Risk

    K2M, Inc. is recalling Aleutian Lordotic Spreader systems because the welded tips may break off during spinal procedures.

    Product
    K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90139, UDI # 10888857108523, Size 24x8mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2095-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may detach from its post inside the packaging, resulting in loose coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 left, Sterile, Catalog # 504-02-66F-L, UDI (01)07613327012491(17)
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-2043-2020·2020-05-27

    Medline Silicone Foley Catheter Recalled Due to Loose Silicone Particulate

    Medline Industries is recalling specific lots of silicone Foley catheters because loose silicone particulate was found on the device shaft.

    Product
    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2084-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled for Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-2061-2020·2020-05-27

    Bovie Medical Recalls Renuvion J-Plasma Precise Handpieces Due to Fracture Risk

    Bovie Medical Corporation is recalling Renuvion/J-Plasma Precise Handpieces because unexpected stress fractures may cause the shaft to fragment during clinical use.

    Product
    Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, and APYX-330BPS. Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open…
    Category
    Medical Device
    Distribution
    Distributed nationwide