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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19801–19825 of 27682

  • HighFDA (Devices)·Z-1768-2017·2017-04-19

    Nihon Kohden Bedside Monitor Recall for Pause Function Defect

    Nihon Kohden America Inc is recalling 654 bedside monitors because the pause function on central monitors fails to automatically resume when connected to specific Life Scope G9 units.

    Product
    Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1790-2017·2017-04-19

    Windstone Eye Cataract Kits Recalled for Sterile Packaging Compromise

    Windstone Medical Packaging is recalling Eye Cataract Packs because the sterile packaging of the included eye pad may be compromised.

    Product
    Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1763-2017·2017-04-19

    Roche Recalls Cobas 8100 Modules Due to Potential Sample Spillage

    Roche Diagnostics is voluntarily recalling 45 Cobas 8100 reformatter modules because a software issue can cause rack crashes and sample spillage, posing a risk of exposure to infectious material.

    Product
    Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1774-2017·2017-04-19

    Draegar Medical Systems Recalls Kappa and Scio Patient Monitors

    Draegar Medical Systems is recalling Kappa and Scio patient monitors because a low oxygen alarm may fail to sound when oxygen levels drop below the set limit.

    Product
    Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio Four plus. Catalog Number(s): MS18597/MS18596/MS18853. Product Usage: The devices are intended to be used in the environment where patient care is provided by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1762-2017·2017-04-19

    Merge Healthcare Recalls iConnect Enterprise Archive Software Due to Display Error

    Merge Healthcare is recalling iConnect Enterprise Archive software because an error message can prevent users from viewing prior studies. The recall affects 333 sites nationwide and internationally.

    Product
    iConnect Enterprise Archive (ICEA) software. The firm name on the labeling is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1814-2017·2017-04-19

    Aesculap Minop InVent 30 Trocar System Recalled for Sharp Edges

    Aesculap Implant Systems LLC is recalling the Minop InVent 30 Trocar System because sharp edges may abrade insulation during use.

    Product
    AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1739-2017·2017-04-12

    Recall of Sterile Eye Pads Due to Compromised Sterility Barrier

    Covidien LLC is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility.

    Product
    Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1744-2017·2017-04-12

    Recall of Curity Sodium Chloride Dressings Due to Sterility Compromise

    Covidien LLC is recalling Curity Sodium Chloride Dressings because the sterile barrier is breached, compromising sterility. The recall affects lots with expiration dates from February 2017 through November 2019.

    Product
    Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item Code: 3339 Curity Sodium Chloride Dressing is indicated for use on exudating and/or infected wounds
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1745-2017·2017-04-12

    Recall of Curity Saline Dressings Due to Compromised Sterility

    Covidien LLC is recalling Curity Saline Dressings because the sterile barrier was breached, compromising sterility. The recall covers lots with expiration dates from February 2017 through November 2019.

    Product
    Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2017·2017-04-12

    Philips BrightView X Gamma Camera Recall for Brake Hub Assembly Error

    Philips is recalling BrightView X 3/4 gamma cameras because a brake hub assembly error can cause the detector to backdrive.

    Product
    BrightView X 3/4 model number 882479 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated…
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1707-2017·2017-04-12

    Philips IntelliVue MX4O Monitor Recall for Alarm Failure

    Philips is recalling IntelliVue MX4O Patient Wearable Monitors that may fail to switch to Monitor Mode with audible alarms if the connection to the central system is lost.

    Product
    Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only Product Usage: Indicated for use by health care professionals…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1736-2017·2017-04-12

    Centurion Convenience Kits Recalled Due to Sterile Packaging Breach

    Centurion Medical Products is recalling 540 Convenience Kits containing eye pads due to a potential breach in sterile packaging.

    Product
    CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1741-2017·2017-04-12

    Recall of Sterile Eye Pads Due to Compromised Sterility Barrier

    Covidien is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility. The recall affects units distributed worldwide.

    Product
    Covidien Curity Eye Pad Item Code: 91650 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1731-2017·2017-04-12

    Centurion Ophthalmic Dressing Kits Recalled for Sterile Packaging Breach

    Centurion Medical Products is recalling 210 ophthalmic dressing kits due to a potential breach in the sterile packaging of the included eye pads.

    Product
    OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1751-2017·2017-04-12

    Philips BrightView XCT Gamma Cameras Recalled for Brake Hub Assembly Error

    Philips is recalling 90 BrightView XCT gamma cameras because a brake hub assembly error can cause the detector to backdrive.

    Product
    BrightView XCT model number 882482 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and…
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1730-2017·2017-04-12

    Centurion Medical Recalls Post-Op Eye Trays Due to Sterile Packaging Breach

    Centurion Medical Products is recalling 476 Post-Op Eye Trays because the sterile eye pads inside may have had a packaging breach.

    Product
    POST-OP EYE TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1735-2017·2017-04-12

    Centurion Convenience Kits Recalled Due to Potential Sterile Packaging Breach

    Centurion Medical Products is recalling 1,692 Convenience Kits containing eye pads due to a potential breach in sterile packaging.

    Product
    OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1743-2017·2017-04-12

    Sterile Saline Dressing Recalled Due to Compromised Sterility Barrier

    FDA is recalling Kerlix Super Sponge Saline Dressings because the sterile barrier is breached, potentially compromising sterility.

    Product
    Covidien Kerlix Super Sponge Saline Dressing, Sterile Item Code: 3338 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1732-2017·2017-04-12

    Centurion Convenience Kits Recalled for Potential Sterile Packaging Breach

    Centurion Medical Products is recalling 588 Convenience Kits containing Curity Oval Eye Pads due to a potential breach in sterile packaging.

    Product
    OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1750-2017·2017-04-12

    Philips Recalls 84 BrightView SPECT Gamma Cameras Due to Brake Hub Defect

    Philips is recalling 84 BrightView SPECT gamma cameras because a brake hub assembly error can cause the detector to backdrive.

    Product
    BrightView SPECT model number 882480 BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated…
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-1742-2017·2017-04-12

    Recall of Sterile Wound Dressings Due to Compromised Sterility Barrier

    Covidien is recalling Curity Wet Dressings because the sterile barrier was breached, potentially compromising sterility. The recall affects units distributed worldwide.

    Product
    Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1746-2017·2017-04-12

    BD Vacutainer Blood Collection Tubes Recalled for Stopper Pullout Risk

    Becton Dickinson is recalling specific lots of BD Vacutainer Buffered Sodium Citrate blood collection tubes because stoppers may pull out during use.

    Product
    BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tubes, 4.5 mL, 13 x 75 mm, Mfd: Becton Dickinson and Company Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection Tube that provides means of collecting, transporting and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2017·2017-04-12

    Recall of Sterile Eye Pads Due to Compromised Sterility Barrier

    Covidien LLC is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility.

    Product
    Covidien Curity Eye Pad Oval, 1-5/8 x 2-5/8 (4.2 cm x 6.7 cm), Sterile Item Code: 2841 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1734-2017·2017-04-12

    Centurion Medical Recalls Post-Operative Ophthalmic Dressing Kits Due to Sterility Concerns

    Centurion Medical Products is recalling 45 post-operative ophthalmic dressing kits because the eye pads inside may have had a breach in sterile packaging.

    Product
    POST-OPERATIVE OPHTHALMIC DRESSING TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.
    Category
    Medical Device
    Distribution
    9 states
  • CriticalFDA (Devices)·Z-1417-2017·2017-04-05

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Potential Failure to Deliver Therapy

    Philips is recalling HeartStart MRx Monitor/Defibrillators because they may fail to deliver therapy or monitoring when operating on a single battery.

    Product
    HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9
    Category
    Medical Device
    Distribution
    Distributed nationwide