The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

101–125 of 21707

  • ModerateFDA (Devices)·Z-0018-2027·2026-10-07

    ASP Global Recalls Expressaire Disposable Tourniquet Cuffs Due to Incorrect Expiration Date

    ASP Global, LLC. is recalling Expressaire Disposable Tourniquet Cuffs because they are labeled with a 10-year shelf life, while the validated shelf life is 5 years.

    Product
    Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 20" X 6" 1-LINE (CS 10) NAVY BLUE Model/Catalog Number: 564017 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0047-2027·2026-10-07

    ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates

    ASP Global is recalling 4,850 sterile disposable tourniquet cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.

    Product
    Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-Line, Green Model/Catalog Number: ASP-564014 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0010-2027·2026-10-07

    ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates

    ASP Global, LLC. is recalling Expressaire disposable tourniquet cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.

    Product
    Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 24" X 4" 1-LINE (CS 10) YELLOW Model/Catalog Number: 564008 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3310-2026·2026-10-07

    Philips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports

    Philips is recalling Ingenia Ambition S and X MRI systems because diffusion tensor imaging (DTI) exports contain incorrect data, preventing correct processing by third-party software.

    Product
    Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 782159 (S), 5. 782194 (S), 6. 781356 (X), 7. 782109 (X), 8. 782138 (X), 9. 782160 (X), 10. 782195 (X); Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0016-2027·2026-10-07

    ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates

    ASP Global, LLC. is recalling 2,600 units of Expressaire Disposable Tourniquet Cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.

    Product
    Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 44" X 4" 1-LINE (CS 10) GREEN Model/Catalog Number: 564014 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0015-2027·2026-10-07

    ASP Global Recalls Expressaire Disposable Tourniquet Cuffs Due to Incorrect Expiration Date

    ASP Global, LLC. is recalling Expressaire Disposable Tourniquet Cuffs because they are labeled with a 10-year shelf life, while the correct validated shelf life is 5 years.

    Product
    Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 34" X 4" 2-LINE (CS 10) BLUE Model/Catalog Number: 564013 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0067-2027·2026-10-07

    Custom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays

    Custom Interventional Pain Management is recalling 56 units of Mastisol Skin Adhesive trays due to manufacturing issues with the liquid skin adhesive.

    Product
    Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM Product Name: Mastisol Skin Adhesive Model/Catalog Number: 24161B (Ferndale and Medline); Tray 17025 17g continuous PBN tray (CIPM) Software Version: n/a Product Description: Skin Adhesive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0051-2027·2026-10-07

    Recall of MPR Single Use Tourniquet Cuffs Due to Incorrect Expiration Date

    ASP Global, LLC. is recalling MPR Single Use Tourniquet Cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.

    Product
    Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 26" DUAL BLADDER, 2 LINE (10) Model/Catalog Number: DB-7024-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3284-2026·2026-10-07

    United Imaging uMI Panorama 35 PET/CT Systems Recalled for Software Defect

    Shanghai United Imaging Healthcare is recalling seven uMI Panorama 35 PET/CT systems due to a software issue that may hide patient images, potentially requiring rescans.

    Product
    Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0039-2027·2026-10-07

    ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates

    ASP Global is recalling sterile disposable tourniquet cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.

    Product
    Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 18" X 4" 1-Line, Red Model/Catalog Number: ASP-564006 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3299-2026·2026-10-07

    Olympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy

    Olympus Corporation of the Americas is recalling 72 units of the M3 Gold Autoclavable Foroblique Telescope 30 due to discrepancies between sterilization parameters in the Instructions for Use and the Japanese package insert.

    Product
    Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3280-2026·2026-10-07

    United Imaging uCT 780 CT System Recalled for Software Visibility Issue

    Shanghai United Imaging Healthcare is recalling 14 uCT 780 CT systems due to a software defect that may hide patient images, potentially requiring rescans.

    Product
    Computed Tomography X-ray System, Model: uCT 780 with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0049-2027·2026-10-07

    ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates

    ASP Global, LLC. is recalling 30 units of MPR Disposable Tourniquet Cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.

    Product
    Brand Name: MPR Product Name:DISPOSABLE TOURNIQUET CUFF 20" DUAL BLADDER, 1 LINE (10) Model/Catalog Number: DB-7018-01Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0038-2027·2026-10-07

    ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates

    ASP Global is recalling sterile disposable tourniquet cuffs because they are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years.

    Product
    Brand Name: ASP Global Product Name:DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-Line, Plum Model/Catalog Number: ASP-564003 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0006-2027·2026-10-07

    Expressaire Disposable Tourniquet Cuff Recalled for Incorrect Expiration Date

    ASP Global is recalling Expressaire Disposable Tourniquet Cuffs because the expiration date is incorrect. The product is labeled with a 10-year shelf life, but the validated shelf life is 5 years.

    Product
    Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 12" X 3.5" 2-LINE (CS 10) PLUM Model/Catalog Number: 564003 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0019-2027·2026-10-07

    ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Date

    ASP Global, LLC. is recalling 260 units of Expressaire Disposable Tourniquet Cuffs because the products are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years.

    Product
    Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 26" X 6" 1-LINE (CS 10) ORANGE Model/Catalog Number: 564019 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0054-2027·2026-10-07

    FDA Recalls MPR Tourniquet Cuffs Due to Incorrect Expiration Dates

    ASP Global, LLC. is recalling 970 MPR single-use tourniquet cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.

    Product
    Brand Name: MPR Product Name:SINGLE USE TOURNIQUET CUFF 24" 2 LINE (10) Model/Catalog Number: DT-7024-02Q Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to reduce or totally…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0035-2027·2026-10-07

    FDA Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates

    ASP Global, LLC. is recalling Expressaire Disposable BB Tourniquet Cuffs because they are labeled with a 10-year shelf life, but the correct validated shelf life is 5 years.

    Product
    Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 20" X 6" DUAL BLADDER 1-LINE (CS 12) NAVY BLUE Model/Catalog Number: A70107014 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3319-2026·2026-10-07

    Percussionaire Recalls IPV 1 and Phasitron 5 Breathing Circuits for Labeling Update

    Percussionaire Corporation is recalling 61,858 units of IPV 1 and Phasitron 5 breathing circuits to update labeling warnings regarding use with volatile anesthetic delivery systems.

    Product
    Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In-Line Valve Instruction Manual
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0030-2027·2026-10-07

    Expressaire Disposable Tourniquet Cuffs Recalled for Incorrect Expiration Dates

    ASP Global is recalling Expressaire disposable tourniquet cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.

    Product
    Brand Name: Expressaire Product Name:DISPOSABLE TOURNIQUET CUFF, 24" X 4" 2-LINE (CS 18) YELLOW Model/Catalog Number: A70107009 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0003-2027·2026-10-07

    ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates

    ASP Global, LLC. is recalling Expressaire Disposable Tourniquet Cuffs because the expiration dates are incorrect. The products are labeled with a 10-year shelf life, but the validated shelf life is 5 years.

    Product
    Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 1-LINE (CS 18) WHITE Model/Catalog Number: 553322 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and inflated to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3279-2026·2026-10-07

    United Imaging uCT 760 CT System Recalled for Software Visibility Issue

    Shanghai United Imaging Healthcare is recalling one uCT 760 CT system due to a software defect that may hide patient images, potentially requiring rescans.

    Product
    Computed Tomography X-ray System, Model: uCT 760 with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3282-2026·2026-10-07

    United Imaging CT System Recall Due to Software Image Visibility Issue

    Shanghai United Imaging Healthcare is recalling 53 uCT ATLAS Astound CT systems due to a software defect that may hide patient images, potentially requiring rescans.

    Product
    Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3316-2026·2026-10-07

    Philips Upgrade dStream Software Recall for Incorrect DTI Data Exports

    Philips is recalling Upgrade dStream software versions R11-R13 because DTI scan exports contain incorrect diffusion direction data, preventing correct tractography reconstruction.

    Product
    Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0021-2027·2026-10-07

    ASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates

    ASP Global, LLC. is recalling 156 units of Expressaire Disposable Tourniquet Cuffs because they are labeled with a 10-year shelf life instead of the correct 5-year validated shelf life.

    Product
    Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 1-LINE (CS 12) LIGHT BLUE Model/Catalog Number: A70107000 Software Version: Not Applicable Product Description: Sterile Disposable Tourniquet Cuff is used to be wrapped around a patient's limb and…
    Category
    Medical Device
    Distribution
    Distributed nationwide