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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

20226–20250 of 40248

  • ModerateFDA (Devices)·Z-1980-2019·2019-07-24

    Elekta Unity Radiation Therapy System Software Recall

    Elekta is recalling 12 Unity systems because a software defect prevents users from inspecting stored alignment values during quality assurance.

    Product
    Elekta Unity, Image-Guided Radiation Therapy System Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1969-2019·2019-07-24

    Pharmaceutical Innovations Recalls ElectroMist Electrode Conductivity Spray Solution

    Pharmaceutical Innovations, Inc. is recalling ElectroMist electrode conductivity spray solution due to potential failure in antimicrobial effectiveness testing.

    Product
    ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1974-2019·2019-07-24

    Teleflex Medical Recalls RUSCH CARE Premium Drain Bags for Labeling Issues

    Teleflex Medical is recalling RUSCH CARE Premium Drain bags because the labels are not UDI compliant. The agency states this labeling issue is not likely to affect the device's function or performance.

    Product
    RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1975-2019·2019-07-24

    Teleflex Medical Recalls RUSCH Urinary Drainage Bags for Labeling Issues

    Teleflex Medical is recalling RUSCH Urinary Drainage bags because the labels are not UDI compliant. The missing information does not affect the device's function or performance.

    Product
    RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1770-2019·2019-07-17

    Becton Dickinson Recalls Alaris Pump Infusion Sets Due to Occlusion Defect

    Becton Dickinson is recalling Alaris Pump Infusion Sets because a wall thickness variation can cause incomplete occlusion, potentially leading to unintended or faster-than-expected medication delivery.

    Product
    Alaris Pump Infusion Set, Model Codes 10010453, 10010454, 10012144, 10015294, 10015414, 10933805, 11171447, 11404930, 11522558, 11607704, 10013361T, 2110-0500, 2126-0500, 2200-0500, 2411-0500, 2419-0007, 2420-0007, 2420-0500, 2421-0500, 2426-0007, 2426-0500, 2429-0500…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1847-2019·2019-07-17

    GE Healthcare Recalls Panda Infant Radiant Warmers Due to Bedside Panel Cracking

    GE Healthcare is recalling 28,094 Panda Infant Radiant Warmers because the bedside panels and latch areas can crack or break if the unit is moved using them instead of the designated handles.

    Product
    Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1923-2019·2019-07-17

    Philips HeartStart MRx Recall Due to AC Power Module Failure Risk

    Philips is recalling HeartStart MRx devices used with specific AC power modules that may fail, potentially causing loss of power and failure to deliver shocks.

    Product
    Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1874-2019·2019-07-17

    Hamilton Medical Recalls HAMILTON-G5 Ventilators Due to Ambient State Risk

    Hamilton Medical is recalling 4,338 HAMILTON-G5 ventilators with software versions 2.60 or lower because they may enter an ambient state, requiring immediate alternative ventilation.

    Product
    HAMILTON-G5, with software versions less than or equal to 2.60 The HAMILTON-G5/S1 ventilators are designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients. The device is intended for use in the hospital and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1846-2019·2019-07-17

    GE Healthcare Recalls Giraffe Infant Radiant Warmers Due to Panel Cracking

    GE Healthcare is recalling 9,094 Giraffe Infant Radiant Warmers because bedside panels and latch areas can crack or break if the unit is moved using the panels instead of the designated handles.

    Product
    Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1959-2019·2019-07-17

    Applied Medical Recalls Kii Fios First Entry Devices for Sterility Concerns

    Applied Medical Resources Corp is recalling Kii Fios First Entry devices because they may not have met sterility requirements, potentially exposing patients to infectious agents.

    Product
    Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1950-2019·2019-07-17

    Helena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits

    Helena Laboratories is recalling ColoCARE in-vitro diagnostic kits because the positive control failed to react appropriately in some tests.

    Product
    ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-1955-2019·2019-07-17

    MAHURKAR and Argyle acute hemodialysis catheters recalled for inaccurate priming volume labels

    COVIDIEN LLC is recalling MAHURKAR and Argyle acute hemodialysis catheters because the printed priming volume values are higher than the volumes required to fill each lumen.

    Product
    MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 8817142005 8817143005 8817145005 8817146001 8817146007…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1958-2019·2019-07-17

    Canon Radrex-i X-Ray System Software Malfunction Recall

    Canon Medical System is recalling 46 Radrex-i X-Ray Systems due to a software malfunction that prevents image transmission from the wireless flat panel detector.

    Product
    Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1949-2019·2019-07-17

    Helena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits

    Helena Laboratories is recalling ColoCARE diagnostic kits because the positive control failed to react properly, potentially affecting test accuracy.

    Product
    ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-1957-2019·2019-07-17

    Richard Wolf Recalls E-Line Cutting Electrode Due to Incorrect Product Packaging

    Richard Wolf Medical Instruments Corp. is recalling E-Line Cutting Electrodes because some packages contain the wrong electrode type.

    Product
    E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1952-2019·2019-07-17

    Rinovum Recalls Revive Reusable Bladder Support Due to Structural Defect

    Rinovum Women's Health is recalling the Revive Reusable Bladder Support because the device may split or crack during its intended use life.

    Product
    Revive Reusable Bladder Support, Model No. 0025 - Product Usage: The Revive bladder support is intended for temporary management of urinary leakage caused by stress urinary incontinence (SUI) in women, 18 years and older. The device comes in a sealed box, and contains a reusable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1945-2019·2019-07-10

    Bio-Detek Recalls ZOLL Pro-padz Liquid Gel Radiolucent Electrodes

    Bio-Detek, Inc. is recalling ZOLL Pro-padz Liquid Gel Radiolucent electrodes because some may be assembled incorrectly, preventing the delivery of defibrillation or pacing therapy.

    Product
    ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1924-2019·2019-07-10

    Draco Enzymatic Deep-Cleaning Pad Recalled for Bacterial Contamination

    Madison Polymeric Engineering is recalling Draco Enzymatic Deep-Cleaning Pads due to contamination with Stenotrophomonas lactiubi. The affected units were distributed to 13 US states.

    Product
    Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1905-2019·2019-07-10

    Siemens Fluoroscopic X-Ray Systems Recalled for Potential Screw Failure

    Siemens is recalling eight Artis fluoroscopic X-ray systems because screws on the ceiling-mounted support may loosen or snap, posing a risk of severe injury.

    Product
    Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1894-2019·2019-07-10

    Siemens Artis zee X-Ray Systems Recalled for Ceiling Support Screw Failure

    Siemens is recalling 63 Artis zee X-ray systems because ceiling support screws may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1897-2019·2019-07-10

    Siemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure Risk

    Siemens is recalling 29 Artis X-ray systems because ceiling mount screws may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1896-2019·2019-07-10

    Siemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure

    Siemens is recalling 120 Artis X-Ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141
    Category
    Medical Device
    Distribution
    Distributed nationwide