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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16526–16550 of 27500

  • HighFDA (Devices)·Z-0472-2019·2018-11-28

    Beckman Coulter Flow Cytometers Recalled for Signal Loss Defect

    Beckman Coulter is recalling 2,549 flow cytometers worldwide due to a manufacturing defect that may cause signal loss or drifting, potentially affecting patient results.

    Product
    COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2019·2018-11-28

    LeMaitre Vascular Recalls Unsealed Polyurethane Carotid Shunts

    LeMaitre Vascular is recalling 46 units of Pruitt F3-S Polyurethane Outlying Carotid Shunts because the pouches are not sealed, compromising sterility.

    Product
    LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0483-2019·2018-11-28

    GE Healthcare Recalls Panda Freestanding Infant Warmers Due to Electric Leakage

    GE Healthcare is recalling 1,724 Panda Freestanding Infant Warmers worldwide due to a potential electric leakage hazard that could affect users.

    Product
    Panda Freestanding Warmer. Device sold under the following product names: Panda Freestanding Warmer and Panda Freestanding Warmer Generic ATO Model. Infant Radiant warmer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0481-2019·2018-11-28

    GE Healthcare Recalls Giraffe Infant Warmers Due to Electric Leakage Risk

    GE Healthcare is recalling 1,724 Giraffe infant radiant warmers worldwide due to a potential electric leakage hazard that could affect users.

    Product
    Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0480-2019·2018-11-28

    GE Healthcare Recalls Giraffe Incubator Carestations Due to Electric Leakage

    GE Healthcare is recalling 1,724 Giraffe Incubator Carestations worldwide due to a potential electric leakage hazard that could affect users.

    Product
    Giraffe Incubator Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0486-2019·2018-11-28

    Ascom Telligence Nurse Call System Recalled for Communication Failure

    Ascom (US) Inc. is recalling 57 units of the Telligence Nurse Call System because a gateway defect may prevent device failures from being displayed at staff consoles.

    Product
    Ascom Telligence Nurse Call System
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-0479-2019·2018-11-28

    GE Healthcare Recalls Giraffe OmniBed Neonatal Incubators Due to Electric Leakage

    GE Healthcare is recalling 1,724 Giraffe OmniBed Carestation neonatal incubators worldwide due to a potential electric leakage hazard that could affect users.

    Product
    Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0448-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0417-2019·2018-11-21

    AROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex Reinforced BioScaffold 10x12cm devices because the suture material degraded, causing them to fail burst specifications after 18 months.

    Product
    OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-0413-2019·2018-11-21

    GE Healthcare Recalls Aisys Anesthesia System Touchscreen Display Kits

    GE Healthcare is recalling 4,207 Aisys anesthesia system touchscreen display kits because they fail to transition to backup ventilation if a patient stops breathing.

    Product
    Touchscreen display kit. Sold under the following product names: TOUCHSCREEN DISPLAY KIT 11.X ENGLISH FOR USA, TOUCHSCREEN DISPLAY KIT 11.X ENGLISH, TOUCHSCREEN DISPLAY KIT 11.X GERMAN, TOUCHSCREEN DISPLAY KIT 11.X DUTCH, TOUCHSCREEN DISPLAY KIT 11.X FRENCH, TOUCHSCREEN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0426-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold mesh devices because the suture material degraded, causing them to fail burst specifications.

    Product
    OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0450-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0460-2019·2018-11-21

    Virtual Imaging RadPRO Mobile X-Ray System Recalled for Mount Separation Risk

    Virtual Imaging is recalling 253 RadPRO Mobile 40kW Digital X-Ray Systems because the tube head may separate and fall off the unit.

    Product
    RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0438-2019·2018-11-21

    Stryker Spirit Plus Bed Recall for Potential Entrapment Risk

    Stryker is recalling 20,030 Spirit Plus hospital beds with high rail siderails due to non-compliance with safety standards and a potential risk of patient entrapment.

    Product
    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0370-2019·2018-11-21

    GE Healthcare Recalls Gamma Camera Systems Due to Falling Detector Risk

    GE Healthcare is recalling 1,166 Millennium MG gamma camera systems because a detector can detach and fall.

    Product
    GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0441-2019·2018-11-21

    R82 A/S Recalls Heron Toilet and Bath Chairs Due to Aluminum Gas Spring

    R82 A/S is recalling 687 Heron toilet and bath chairs because they contain aluminum gas spring heads. The recall is a replacement campaign for these specific units.

    Product
    Heron toilet and bath chair Model 880505-01 & 880505-11
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0425-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold 16x20cm devices because the PGA suture material degraded, causing them to fail burst specifications.

    Product
    OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0422-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Devices

    AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications.

    Product
    OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0442-2019·2018-11-21

    Arthrex Recalls 3.2mm Proximal Reamer Due to Potential Breakage During Use

    Arthrex, Inc. is recalling 832 units of the 3.2mm Proximal Reamer/Cannulated Drill because the instrument may break during use.

    Product
    3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill…
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-0456-2019·2018-11-21

    American Contract Systems Recalls Powdered Surgical Gloves

    American Contract Systems is recalling 1,180 kits of powdered surgical gloves because they are an FDA banned substance.

    Product
    Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves included in ACS surgical convenience kits Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0451-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Malfunction

    Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0445-2019·2018-11-21

    Luminex Recalls Verigene Blood Culture Gram-Positive Nucleic Acid Kits

    Luminex Corporation is recalling 12,700 trays of Verigene Blood Culture Gram-Positive Nucleic Acid Kits due to a potential for false negative results.

    Product
    VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0435-2019·2018-11-21

    AROA Biosurgery Recalls OviTex 2S Reinforced BioScaffold Mesh Devices

    AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold devices because the suture material degraded, causing them to fail burst specifications after 18 months.

    Product
    OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
    Category
    Medical Device
    Distribution
    8 states