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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25051–25075 of 40357

  • HighFDA (Devices)·Z-0599-2018·2018-02-21

    3M Bair Hugger Underbody Blanket Recall for Airflow Occlusion Risk

    3M is recalling Bair Hugger Normothermia System blankets due to a design change that may cause unintended airflow occlusion and limited inflation.

    Product
    3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 63700 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0595-2018·2018-02-21

    Hologic Panther Fusion Recalled Due to Falling Glass Panel Hazard

    Hologic is recalling 103 Panther Fusion instruments because the glass panel may separate from the monitor and fall, potentially striking an operator.

    Product
    Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0609-2018·2018-02-21

    Zimmer Biomet Recalls BlockAid Cut Resistant Surgical Glove Liners

    Zimmer Biomet is recalling BlockAid Cut Resistant Surgical Glove Liners because the product lacks sterility assurance. The recall affects 1,863 units distributed in 29 states and three countries.

    Product
    BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127…
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0628-2018·2018-02-21

    Zimmer Biomet Recalls AGC 2000 LP Patella Knee Implants

    Zimmer Biomet is recalling 11 AGC 2000 LP Patella knee implants because they were over-molded, causing the outside diameter to not match the required specifications.

    Product
    AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0579-2018·2018-02-21

    GE Carestation 600 Series Recalled for Possible Incomplete CO2 Seal

    GE Medical Systems is recalling 5,148 Carestation 600 Series anesthesia machines due to a possible incomplete seal between the CO2 absorber and the breathing circuit.

    Product
    Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-0603-2018·2018-02-21

    Exactech Orthopedic Surgical Tool Recalled for Fracture Risk

    Exactech is recalling 41 GPS Total Shoulder Application 3.2mm Vix Bits because they may fracture during use.

    Product
    Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0627-2018·2018-02-21

    Zimmer Biomet Recalls AGC 2000 LP Patella Knee Implant Devices

    Zimmer Biomet is recalling 28 AGC 2000 LP Patella knee implants because they were over-molded, leaving the outside diameter nonconforming to the print dimension.

    Product
    AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0598-2018·2018-02-21

    3M Bair Hugger Warming Blanket Recall for Airflow Occlusion Risk

    3M is recalling Bair Hugger warming blankets because a design change may cause airflow blockage, leading to limited inflation during use.

    Product
    3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0629-2018·2018-02-21

    Hemotherm Dual Reservoir Cooler/Heater System Recall for Updated Cleaning Instructions

    Cincinnati Sub-Zero is recalling 1,355 Hemotherm units to provide updated instructions for cleaning and disinfection to address NTM infection risks.

    Product
    Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0614-2018·2018-02-21

    Siemens Artis one X-ray Systems Recalled for Monitor Display Issues

    Siemens is recalling Artis one fluoroscopic X-ray systems because the monitor display may blink or show a blue/black screen.

    Product
    Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray…
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0601-2018·2018-02-21

    Arrow International Recalls PICC Catheter Kits Due to Incorrect Components

    Arrow International is recalling specific PICC catheter kits because they may contain the wrong catheter size or type, potentially delaying patient treatment.

    Product
    ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0571-2018·2018-02-21

    B. Braun Recalls Perifix FX Epidural Anesthesia Trays Due to Foreign Matter

    B. Braun Medical is recalling Perifix FX Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter above release specifications.

    Product
    Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051, 552083, 552119, 555569. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0566-2018·2018-02-21

    Medtronic Recalls Two Angled Drills Due to Tip Extension Discrepancy

    Medtronic is recalling two units of the ANGLED DRILL (REF 6630902) because the drill tip extension is longer than the printed specification indicates.

    Product
    Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0630-2018·2018-02-21

    Cook Inc. Recalls Central Venous Catheter Sets Due to Fit Issues

    Cook Inc. is recalling 85 Central Venous Catheter Sets because they may not fit over a guide wire, potentially causing procedure delays.

    Product
    Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-501J Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0612-2018·2018-02-21

    Zimmer Surgical Recalls A.T.S. 4000TS Tourniquet Systems for Labeling Updates

    Zimmer Surgical Inc is recalling 8,231 A.T.S. 4000TS Tourniquet Systems to update on-device labels and operator manuals, and to reduce the required separation distance from RF communication equipment.

    Product
    A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0631-2018·2018-02-21

    Cook Central Venous Catheter Tray Recalled for Fit Issues

    Cook Inc. is recalling 25 Central Venous Catheter Trays because they may not fit over the guide wire, potentially causing procedure delays.

    Product
    Central Venous Catheter Tray Triple Lumen Polyurethane, Catalog Identifier: C-UTLMYJ-501J Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0619-2018·2018-02-21

    Aesculap ELAN 4 Burr Accessories Recalled for Lack of FDA Clearance

    Aesculap Implant Systems LLC is recalling ELAN 4 Burr accessories because they were marketed without 510(k) premarket notification clearance.

    Product
    ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RING ROSEN BURR TC D1.0 ELAN 4 1-RING ROSENBURR+ D1.0 ELAN 4 1-RING ROSEN BURR D1.4 ELAN 4 1-RING ROSENBURR+ D1.4 ELAN 4 1-RING ROSEN BURR D1.8 ELAN 4 1-RING…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0597-2018·2018-02-21

    OrthoPediatrics Recalls 7.0mm Pedicle Screws Due to Color Anodizing Error

    OrthoPediatrics Corp is recalling 24 units of 7.0mm x 40mm pedicle screws because they were color anodized with the same color used for 5mm screws.

    Product
    Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0569-2018·2018-02-21

    B. Braun Recalls Pencan Spinal Needle Trays Due to Foreign Matter

    B. Braun Medical is recalling 11,920 units of Pencan Spinal Needle Trays because they contain loose polypropylene foreign matter above release specifications.

    Product
    Pencan Spinal Needle Tray. Product Catalog Number: 333865. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0570-2018·2018-02-21

    B. Braun Recalls Perifix Epidural Anesthesia Trays Due to Foreign Matter

    B. Braun Medical is recalling Perifix Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter above release specifications.

    Product
    Perifix Epidural AnesthesiaTray. Product Catalog Numbers: 551879, 551994, 552024. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0572-2018·2018-02-21

    B. Braun Recalls PENCAN Spinal Anesthesia Trays Due to Foreign Matter

    B. Braun Medical is recalling PENCAN Spinal Anesthesia Trays because they contain needles with loose polypropylene foreign matter above release specifications.

    Product
    PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0622-2018·2018-02-21

    Medtronic Recalls Clip Gun Scalp Clip Kits Due to Packaging Defects

    Medtronic is voluntarily recalling specific Clip Gun Scalp Clip Kits and Applicators because they did not meet current packaging performance standards.

    Product
    Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10)
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0573-2018·2018-02-21

    B. Braun Recalls Spinal Anesthesia Kits Due to Foreign Matter

    B. Braun Medical is recalling Spinal & Epidural Anesthesia Trays because they contain needles with loose polypropylene foreign matter above release specifications.

    Product
    Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
    Category
    Medical Device
    Distribution
    Distributed nationwide