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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19101–19125 of 40124

  • LowFDA (Devices)·Z-0297-2020·2019-11-13

    Helena Laboratories Recalls SPIFE Alkaline Hemoglobin Kits Due to Incorrect Instructions

    Helena Laboratories is recalling 899 SPIFE Alkaline Hemoglobin Kits because they contain incorrect instruction inserts referencing unavailable electrode parameters.

    Product
    SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
    Category
    Medical Device
    Distribution
    22 states
  • CriticalFDA (Devices)·Z-0203-2020·2019-11-06

    Ethicon Echelon Flex Powered Plus Stapler Recalled for Anvil Defect

    Ethicon Endo-Surgery Inc is recalling 2,112 Echelon Flex Powered Plus ENDOPATH 60mm Staplers worldwide due to out-of-specification anvil components that may compromise staple line integrity.

    Product
    ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0201-2020·2019-11-06

    Ethicon Recalls ECHELON FLEX Staplers Due to Anvil Defect

    Ethicon Endo-Surgery Inc is recalling 255 units of the ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler because an out-of-specification anvil may cause malformed staples and compromised staple lines.

    Product
    ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0221-2020·2019-11-06

    Thoratec CentriMag Motor Recalled Due to Electromagnetic Interference Issues

    Thoratec is recalling CentriMag Acute Circulatory Support System motors due to reports of motor and pump issues caused by electromagnetic interference.

    Product
    CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0200-2020·2019-11-06

    Ethicon Echelon Flex Endopath Stapler Recall for Out-of-Spec Anvil

    Ethicon is recalling Echelon Flex Endopath 60mm Staplers due to out-of-specification anvil components that may compromise staple line integrity.

    Product
    ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0222-2020·2019-11-06

    MedComp C3 Wave App Recalled Due to ECG Display Failure

    Medical Components, Inc dba MedComp is recalling the C3 Wave App v. 2.0.5 because it malfunctions on iOS 12, preventing ECG display during PICC procedures.

    Product
    C3 Wave App, v. 2.0.5
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-0202-2020·2019-11-06

    Ethicon Echelon Flex Powered Plus Endopath 60mm Stapler Recall

    Ethicon is recalling 5,040 Echelon Flex Powered Plus Endopath 60mm Staplers due to out-of-specification anvil components that may compromise staple line integrity.

    Product
    ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0194-2020·2019-11-06

    TIDI Products Recalls Posey Connected Twice-As-Tough Cuffs for Design Defects

    TIDI Products is recalling Posey Connected Twice-As-Tough Cuffs because they do not meet design specifications. The recall affects 7,692 units distributed in the US and internationally.

    Product
    Posey Connected Twice-As-Tough Cuffs
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0258-2020·2019-11-06

    Draeger Infinity Acute Care System Recalled for Cybersecurity Vulnerabilities

    Draeger Medical Systems is recalling 5,634 Infinity Acute Care System monitors due to cybersecurity vulnerabilities that may cause device reboots and loss of alarm functionality.

    Product
    The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0249-2020·2019-11-06

    Intuitive Surgical Recalls EndoWrist Suction Irrigator Due to Silicone Particle Risk

    Intuitive Surgical is recalling EndoWrist Suction Irrigator instruments because silicone particles may form and be introduced into patients during irrigation.

    Product
    EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0233-2020·2019-11-06

    ConvaTec Recalls Convex Two-Piece Ostomy Skin Barriers Due to Off-Center Stoma Hole

    ConvaTec is recalling convex two-piece ostomy skin barriers manufactured between February 2017 and September 2018 because the stoma hole may be off-center.

    Product
    Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3) Natura 4) Varicare Product Usage: stoma management
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0255-2020·2019-11-06

    Centurion Medical Recalls Port Access Kits Due to Needle Issue

    Centurion Medical Products Corporation is recalling 11,260 Port Access Kits distributed in Illinois. The recall was initiated by the supplier due to an issue with GRIPPER Needles.

    Product
    Kit, Port Access Product Code: DYNDC1582A
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0227-2020·2019-11-06

    Stryker Neurovascular Recalls Synchro2 Soft Guidewires for Sterility Concerns

    Stryker Neurovascular is recalling 831 units of Synchro2 Soft Guidewires due to a potential loss of sterility. The recall covers units distributed worldwide.

    Product
    Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2020·2019-11-06

    Valeritas Recalls DEMO No Needle Corrugated Cartons Due to Needle Risk

    Valeritas is recalling 21,714 DEMO No Needle Corrugated Cartons because they may contain a needle. The recall covers units distributed nationwide in the U.S.

    Product
    DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0234-2020·2019-11-06

    Pajunk Sprotte Lumbar Puncture Needles Recalled for Sterility Concerns

    Pajunk GmbH is recalling Sprotte Lumbar Puncture Needles because a packaging sealing issue may affect sterility. The recall covers 40,475 devices distributed worldwide.

    Product
    SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); 4. Sprotte 22G x 103mm w…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0220-2020·2019-11-06

    LivaNova Recalls SORIN Heater-Cooler Systems Due to Disinfectant Failure

    LivaNova USA Inc. is recalling SORIN Heater-Cooler System 3T units because a chemical reaction may render the water preservative ineffective, potentially allowing micro-organism growth.

    Product
    SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling system. The three separate water circuits have been developed to serve as: "…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0252-2020·2019-11-06

    BD Vacutainer Eclipse Blood Collection Needles Recalled for Missing Bevel

    Becton Dickinson is recalling specific lots of BD Vacutainer Eclipse Blood Collection Needles because a missing bevel on the non-patient end caused blood leakage.

    Product
    BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0251-2020·2019-11-06

    Eversense CGM Sensors Recalled for Premature Function Failure

    Senseonics is recalling 1,344 Eversense CGM sensors nationwide because they may stop working early due to inadequate hydration of the glucose-sensing surface.

    Product
    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0239-2020·2019-11-06

    Medtronic 2090 CareLink Programmer Recall for Inaccurate Longevity Estimates

    Medtronic is recalling 2090 CareLink Programmer units because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.

    Product
    Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
    Category
    Medical Device
    Distribution
    0 states