The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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23126–23150 of 27699

  • HighFDA (Devices)·Z-2256-2015·2015-08-05

    Philips Brilliance iCT SP CT Systems Recalled for Software Defects

    Philips Medical Systems is recalling two Brilliance iCT SP CT systems due to software issues affecting image quality, dose control, and heart rate measurement.

    Product
    Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2015·2015-08-05

    Philips Brilliance iCT CT Systems Recalled for Software and Hardware Defects

    Philips is recalling 38 Brilliance iCT CT systems due to software errors affecting dose control, heart rate measurement, and image artifacts.

    Product
    Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2308-2015·2015-08-05

    Anspach 4mm Diamond Ball Dissection Tool Recall for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 246 units of the 4mm Diamond Ball dissection tool because the shaft exposure may be greater than labeled when used with certain attachments.

    Product
    ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2258-2015·2015-08-05

    Philips CT Systems Recalled for Software and Hardware Defects

    Philips is recalling 139 Ingenuity Core 128 CT scanners due to software errors affecting image quality, dose control, and heart rate monitoring.

    Product
    Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2315-2015·2015-08-05

    Tornier Aequalis Humeral Nail Targeting Jig Recalled for Mast Separation

    Tornier, Inc. is recalling 99 Aequalis Humeral Nail Targeting Jigs because the mast can separate from the boom, potentially affecting surgical alignment and screw fixation.

    Product
    Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2307-2015·2015-08-05

    Anspach G1 Dissection Tools Recalled for Inconsistent Shaft Exposure Labeling

    The Anspach Effort, Inc. is recalling 99 G1 dissection tools because the labeled shaft exposure may be inconsistent with actual usage, potentially resulting in greater exposure than specified.

    Product
    ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2281-2015·2015-08-05

    Anspach Fluted Drum Dissection Tools Recalled for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 138 fluted drum dissection tools because the shaft exposure may be greater than labeled when used with certain attachments.

    Product
    ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM , REF L-5DRC-G1. Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2283-2015·2015-08-05

    Anspach Fluted Drum Dissection Tools Recalled for Inconsistent Shaft Exposure

    The Anspach Effort, Inc. is recalling 177 fluted drum dissection tools because the shaft exposure may be greater than labeled when used with certain attachments.

    Product
    ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2289-2015·2015-08-05

    Anspach Diamond Ball Tools Recalled for Inconsistent Shaft Exposure Labeling

    The Anspach Effort, Inc. is recalling 72 Anspach Extra Coarse Diamond Ball tools because the labeled shaft exposure may be inconsistent with actual use, potentially resulting in greater exposure.

    Product
    ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2253-2015·2015-08-05

    OxySure Model 615 Oxygen Cartridges Recalled for Flow Rate Defect

    Oxysure Systems is recalling 1,005 Model 615 oxygen cartridges because they do not meet FDA flow rate standards.

    Product
    OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2069-2015·2015-07-29

    Western OxyTOTE Portable Oxygen System Regulators Recalled for Ignition Risk

    Western / Scott Fetzer Company is recalling OxyTOTE Portable Oxygen System regulators due to a risk of ignition and rupture of the oxygen cylinder.

    Product
    Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained…
    Category
    Medical Device
    Distribution
    47 states
  • SevereFDA (Devices)·Z-2161-2015·2015-07-29

    FDA Recalls Sureflex 910 Lithotripsy Fibers Due to Cleaning Validation Issues

    American Medical Systems is recalling 16,710 Sureflex 910 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Sureflex 910 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2174-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

    American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 12S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2195-2015·2015-07-29

    Philips Recalls GEMINI TF 16 Slice CT/PET Systems Due to Software Defects

    Philips is recalling 13 GEMINI TF 16 Slice CT/PET systems worldwide due to four software defects in the Tumor LOC application that may affect treatment accuracy.

    Product
    GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2196-2015·2015-07-29

    Philips GEMINI TF 64 Slice CT/PET System Software Defect Recall

    Philips is recalling 22 GEMINI TF 64 Slice CT/PET systems due to software defects that may cause incorrect tissue irradiation.

    Product
    GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2194-2015·2015-07-29

    Philips Gemini LXL CT/PET Systems Recalled for Software Defects

    Philips is recalling two Gemini LXL CT/PET systems due to software defects that may cause incorrect radiation delivery to patients.

    Product
    GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2113-2015·2015-07-29

    FDA Recalls Sterile Double Basin Kits with Compromised Devon Light Gloves

    The FDA is recalling 5,786 sterile Double Basin Kits because the included Devon Light Gloves contain splits or holes that compromise sterility.

    Product
    Double Basin Kit ,Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31145504 7708 Double Basin Kit 50007898 7898-T8 Double Basin Kit 50007899 7899-T8 Double Basin Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2137-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Detachment Risk

    DePuy Orthopaedics is recalling ATTUNE FB PS Articulation Surface instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation…
    Category
    Medical Device
    Distribution
    51 states
  • SevereFDA (Devices)·Z-2198-2015·2015-07-29

    Philips Recalls GEMINI TF Base CT/PET Systems Due to Software Defects

    Philips is recalling two GEMINI TF Base CT/PET systems because four software defects in the Tumor LOC application may cause incorrect tissue irradiation.

    Product
    GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2111-2015·2015-07-29

    FDA Recalls Sterile Surgical Kits with Compromised Gloves

    The FDA is recalling 4,136 sterile surgical kits because the Devon Light Gloves inside contain splits or holes that compromise sterility.

    Product
    ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-UNI Universal ASC Kit 50000512 7557-UNI Universal ASC Kit 50000515 7667-BRT Breast ASC Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2156-2015·2015-07-29

    FDA Recalls Sureflex 150 Lithotripsy Fibers Due to Sterilization Validation Issues

    American Medical Systems is recalling Sureflex 150 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.

    Product
    Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2110-2015·2015-07-29

    Surgical Set Up Kits Recalled Due to Sterility Compromise in Gloves

    FDA is recalling 33,256 surgical set up kits containing Devon Light Gloves that have splits or holes compromising sterility.

    Product
    Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2197-2015·2015-07-29

    Philips GEMINI TF Ready CT/PET System Software Defect Recall

    Philips is recalling GEMINI TF Ready CT/PET systems due to software defects that may cause incorrect radiation treatment.

    Product
    GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2175-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

    American Medical Systems is recalling Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 12S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2138-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instrument Recall for Balseal Disassociation Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil may detach and be left in patients during surgery.

    Product
    ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation…
    Category
    Medical Device
    Distribution
    51 states