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 deaths or serious injuries are reported, 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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2601–2625 of 5111

  • SevereFDA (Devices)·Z-1016-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination

    Cardinal Health is recalling AAMI 3 non-reinforced surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1023-2020·2020-02-12

    Cardinal Health Recalls ROYALSILK Gowns Due to Unknown Contamination

    Cardinal Health is recalling ROYALSILK gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    ROYALSILK 2XLARGE, Gown. Item Code 9578
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1020-2020·2020-02-12

    Cardinal Health Recalls Surgical Gowns Due to Unknown Contamination Levels

    Cardinal Health is recalling specific surgical gowns because they contain unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0864-2020·2020-02-05

    Radiometer AQURE basic system software recall for patient data mix-up risk

    Radiometer Medical ApS is recalling AQURE basic system software versions 2.3.5 and below due to a potential patient data mix-up risk when connected to third-party devices.

    Product
    AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0842-2020·2020-01-29

    Palodex Dental X-Ray Imagers Recalled for Power Supply Fire Risk

    Palodex Group Oy is recalling Instrumentarium Dental Express X-ray imagers because slow degradation of plastic insulation in the power supply unit may cause short circuits, heating, and smoke.

    Product
    Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0835-2020·2020-01-29

    Polymer Technology Systems Recalls CardioChek Plus Analyzers Due to Battery Overheating Risk

    Polymer Technology Systems is recalling 44,448 CardioChek Plus Professional Analyzers because a battery terminal defect can cause reverse contact and potential overheating.

    Product
    Henry Schein CardioChek Plus Professional Analyzer, New Analyzer, boxed, with carrying case, Reference Number 4060 HS, 570-0411
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0841-2020·2020-01-29

    KaVo Scan eXam X-Ray Imager Recalled for Power Supply Fire Risk

    Palodex Group Oy is recalling KaVo Scan eXam X-ray imagers because plastic insulation degradation in the power supply may cause short circuits, heating, and smoke.

    Product
    KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0817-2020·2020-01-22

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillator Service Kits

    Physio-Control is recalling 705 LIFEPAK 15 Monitor/Defibrillator service kits because oxidation may prevent the device from delivering a shock.

    Product
    LIFEPAK 15 MONITOR/DEFIBRILLATOR service kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0800-2020·2020-01-22

    Edwards Lifesciences Recalls QuickDraw Venous Cannulas Due to Connector Separation Risk

    Edwards Lifesciences is recalling QuickDraw Venous Cannulas because the device may separate from its connector if used for more than six hours, potentially causing significant blood loss.

    Product
    QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
    Category
    Medical Device
    Distribution
    41 states
  • SevereFDA (Devices)·Z-0799-2020·2020-01-22

    Trilliant Gridlock Ankle Screw Driver Bit Recalled for Specification Defect

    Trilliant Surgical is recalling 20 Gridlock Ankle Screw Driver Bits because they are out of specification and may fail to retain screws during implant procedures.

    Product
    Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0780-2020·2020-01-15

    Stryker T2 Alpha Delta Strike Plate Recalled for Breakage Risk

    Stryker GmbH is recalling T2 Alpha Delta Strike Plate instruments because they can break during nail implantation or removal, potentially causing complications.

    Product
    Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal of nails through the Targeting Device Catalog Number: 2351-0050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0746-2020·2020-01-08

    Thoratec HeartMate 3 Mobile Power Unit Recalled for Static Electricity Risk

    Thoratec Corp. is recalling HeartMate 3 Mobile Power Units because excessive static electricity can cause unrecoverable power loss, potentially reducing blood flow from the left ventricular assist system.

    Product
    HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297, and 106524, UDI or GTIN: 00813024011712 - Product Usage: P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0022-2020·2020-01-01

    Galemed Babi.Plus Pressure Relief Manifold Recalled for Low Venting Pressure

    Galemed is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds because they may vent gas below standard pressure. The recall covers 14,964 units distributed in North Carolina and Nevada.

    Product
    Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0021-2020·2020-01-01

    Galemed Babi.Plus Bubble PAP Valve Recalled for Pressure Relief Defect

    Galemed Corporation is recalling Babi.Plus Bubble PAP Valves because the pressure relief manifold may vent gas below standard pressure.

    Product
    Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0715-2020·2019-12-25

    Arrow Berman Angiographic Catheter Recalled for Potential Leak

    Arrow International Inc. is recalling 71 units of Arrow Berman Angiographic Catheters due to a potential leak in the balloon extension line that could cause serious injury or death.

    Product
    Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0716-2020·2019-12-25

    Arrow Berman Angiographic Catheter Recalled for Potential Balloon Leak

    Arrow International Inc is recalling specific Arrow Berman Angiographic Catheters due to a potential leak in the balloon extension line that could cause serious injury or death.

    Product
    Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0588-2020·2019-12-18

    Cook CrossCath Support Catheter Recalled for Manufacturing Error

    Cook Inc. is recalling six CrossCath Support Catheters due to a manufacturing error that may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0675-2020·2019-12-18

    Cognision Subject Kit Recalled for Potential B. cepacia Contamination

    Neuronetrix Solutions is recalling 3,108 units of the Cognision Subject Kit (Clinical Grade) due to potential contamination with Burkholderia cepacia.

    Product
    Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with external electrodes. Order No. D5000, Part No. PN-1720 - Product Usage: An electroconductive cream for use with external electrodes to reduce the i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0587-2020·2019-12-18

    Cook CrossCath Support Catheter Recall Due to Manufacturing Error

    Cook Inc. is recalling 20 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • CriticalFDA (Devices)·Z-0541-2020·2019-12-11

    GE Healthcare Recalls Giraffe Infant Warmers Due to Latching Defect

    GE Healthcare is recalling Giraffe infant warmers because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.

    Product
    Giraffe Incubator infant warmer
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0609-2020·2019-12-11

    Lens.com Recalls Alcon Air Optix Night & Day Aqua Contact Lenses

    Lens.com is recalling specific lots of Alcon Air Optix Night & Day Aqua contact lenses because they may be counterfeit and have microbial issues.

    Product
    Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0538-2020·2019-12-11

    GE Healthcare Recalls Giraffe OmniBed Infant Warmers Due to Latch Defect

    GE Healthcare is recalling Giraffe OmniBed infant warmers because bedside panels and portholes may appear closed without being latched, posing a risk of patient falls.

    Product
    Giraffe OmniBed infant warmer
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0521-2020·2019-12-04

    Zimmer Biomet Recalls Acromium Flange Sets Due to Cleaning Issues

    Zimmer Biomet is recalling Acromium Flange Sets because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.

    Product
    ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide