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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Minimum severity

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

Clear filters

18626–18650 of 40248

  • HighFDA (Devices)·Z-0807-2020·2020-01-22

    Siemens ARTIS pheno X-Ray System Recalled for Potential Collision Sensor Blockage

    Siemens is recalling six ARTIS pheno X-ray systems because a collision sensor may falsely activate, permanently blocking system movement.

    Product
    Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0801-2020·2020-01-22

    Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components

    Flexicare Medical is recalling BriteBlade Pro laryngoscope blades because internal components may become loose and enter the patient's mouth.

    Product
    BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10, (01)15055788723001 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0806-2020·2020-01-22

    Carestream Recalls Kodak DirectView DR3000/3500 X-Ray Systems for U-Arm Movement

    Carestream Health is recalling 79 Kodak DirectView DR3000/3500 diagnostic x-ray systems due to a potential safety issue involving unintended movement of the U-Arm.

    Product
    Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended to generate and control x-rays for examination of various anatomical regions. The DR Operator Console is the user interface. All operator functions except positioning the Bucky…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0798-2020·2020-01-22

    CooperSurgical Recalls Advanced Endosee Cannulas Due to Unsealed Pouches

    CooperSurgical is recalling 460 boxes of Advanced Endosee Cannulas because some sterile pouches may be unsealed, potentially compromising sterility.

    Product
    ADVANCED ENDOSEE System CANNULA, Cooper Surgical Product Code/Model Number: ESPX5 The Advanced Endosee Cannula (CooperSurgical Product Code: ESPX5) is a sterile, single-use cannula that is part of the Advanced Endosee System. The cannula contains a light source and a camera…
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-0802-2020·2020-01-22

    Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components

    Flexicare Medical Ltd. is recalling BriteBlade Pro laryngoscope blades because internal spring, washer, and bearing components may become loose and separate from the device.

    Product
    BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0808-2020·2020-01-22

    St. Jude Medical Recalls Confirm Rx Insertable Cardiac Monitors

    St. Jude Medical is recalling 2,906 Confirm Rx Insertable Cardiac Monitors because a software defect caused inappropriate low battery indicators.

    Product
    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0804-2020·2020-01-22

    Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components

    Flexicare Medical Ltd. is recalling BriteBlade Pro laryngoscope blades because internal components may become loose and separate, posing a risk of entering the patient's oral cavity.

    Product
    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0815-2020·2020-01-22

    Cook Inc. Recalls Dawson-Mueller Drainage Catheters Due to Leakage Risk

    Cook Inc. is recalling specific lots of Dawson-Mueller Drainage Catheters because they were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.

    Product
    Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35-15-P-5S-CLDM-HC, UL T6. 3-35-25-P-58-CLDM-HC, UL T7.0-35-25-P-5S-CLDM-HC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2020·2020-01-22

    Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components

    Flexicare Medical Ltd. is recalling BriteBlade Pro laryngoscope blades because internal spring, washer, and bearing components may become loose and separate from the device.

    Product
    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2020·2020-01-22

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators Due to Keypad Oxidation

    Physio-Control is recalling 29,952 LIFEPAK 15 Monitor/Defibrillators worldwide because oxidation on the keypad may prevent the device from delivering a shock.

    Product
    LIFEPAK 15 MONITOR/DEFIBRILLATOR that was either manufactured with or received an upgrade kit that contained an affected keypad.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0810-2020·2020-01-22

    Suntech Medical Recalls Model 250D Ambulatory Blood Pressure Monitors for Battery Safety

    Suntech Medical is recalling 384 Model 250D Ambulatory Blood Pressure Monitors due to a user safety issue involving the misuse of rechargeable batteries.

    Product
    Model 250D Ambulatory Blood Pressure Monitor labeled under the following brands: Bravo Mini, part number 99-0233-00; Agilis Mini, part number NJ124 (99-0233-40); and NBP One, part number NBP One (99-0233-10).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0811-2020·2020-01-22

    Stryker Omnifit Crossfire Hip Insert Recall Due to Missing Locking Wire

    Howmedica Osteonics Corp. is recalling 20 units of Stryker Omnifit Crossfire 10 Degree Series II Inserts due to a potential missing locking wire.

    Product
    Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0809-2020·2020-01-22

    Medline Thermistor Foley Catheter Recalled for Temperature Deviation

    Degania Silicone is recalling 2,080 units of Medline Thermistor Foley Catheters because temperature readings did not meet release specifications.

    Product
    Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0812-2020·2020-01-22

    Microbiologics Gram-Positive Blood Culture Control Panel Recall for Hydration Fluid Change

    Microbiologics Inc is recalling 810 units of the Gram-Positive Blood Culture Control Panel because the recommended hydration fluid has changed to sterile DI water or pH 7.2 phosphate buffer.

    Product
    Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0795-2020·2020-01-22

    Riverpoint Medical Recalls 18G Brachy Grids Due to Packaging Integrity

    Riverpoint Medical is recalling 3,234 sterile 18G Brachy Grids because the integrity of the sterile packaging is potentially compromised.

    Product
    Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical, LLC, Portland, OR.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0805-2020·2020-01-22

    Caire FreeStyle Comfort Oxygen Concentrators Recalled for Lack of US Clearance

    Caire, Inc. is recalling four European version FreeStyle Comfort Oxygen Concentrators because they were not cleared for use in the US.

    Product
    CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0796-2020·2020-01-22

    Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling

    Teleflex Medical is recalling RuSCH One piece Male External Regular Catheters because the labels incorrectly state the devices are sterile, though they are not required to be.

    Product
    Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500
    Category
    Medical Device
    Distribution
    11 states
  • LowFDA (Devices)·Z-0797-2020·2020-01-22

    Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling

    Teleflex Medical is recalling RuSCH One piece Male External Medium Catheters because the labels incorrectly state the devices are sterile, though they are not required to be.

    Product
    Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
    Category
    Medical Device
    Distribution
    11 states
  • 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
  • HighFDA (Devices)·Z-0789-2020·2020-01-15

    Abbott Recalls Fast-Cath Hemostasis Introducers Due to Incorrect Size

    Abbott Medical is recalling 380 Fast-Cath Hemostasis Introducers because three lots contained 8F components instead of the labeled 8.5F size.

    Product
    Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2020·2020-01-15

    Baxter Recalls Clearlink Continu-Flo Administration Sets Due to Connection Force Issue

    Baxter Healthcare is recalling Clearlink System Continu-Flo Administration Sets because some units require higher-than-expected force to connect securely.

    Product
    Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a container into the patients vascular system through a vascular access device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0784-2020·2020-01-15

    Intersurgical Double Swivel Elbow Airway Connectors Recalled for Cracking Risk

    Intersurgical Inc is recalling 115,200 Double Swivel Elbow airway connectors because the port may crack and leak.

    Product
    Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0775-2020·2020-01-15

    Medacta Shoulder Implant Recall Due to Screw Insertion Limitation

    Medacta USA Inc. is recalling specific lots of Humeral Anatomical Cementless Metaphysis implants because a dimensional condition may limit the insertion of the locking screw.

    Product
    Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0788-2020·2020-01-15

    Avanos Recalls Haylard Closed Suction Systems Due to Blocked Lumens

    Avanos Medical is recalling Haylard Closed Suction Systems for neonates and pediatrics because the central lumen may be blocked, potentially preventing adequate suctioning of airway secretions.

    Product
    Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP Finished Product Code 109382303; 2. REF 201, with BALLARD Technology, SAP Finished Product Code 109382803; 3. REF 202, Elbow, SAP Finished Product Code 109382903; 4. REF 195-5…
    Category
    Medical Device
    Distribution
    Distributed nationwide