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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13376–13400 of 27500

  • HighFDA (Devices)·Z-2494-2020·2020-07-15

    Radiometer ABL800 FLEX Blood Gas Analyzer Software Recall

    Radiometer Medical ApS is recalling ABL800 FLEX blood gas analyzers due to a software issue that may cause patient mix-ups.

    Product
    Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. The FlexQ module is optional and can be added to all models and configurations.
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2518-2020·2020-07-15

    Kentec Medical Recalls ENFit Polyurethane and Silicone Feeding Tubes

    Kentec Medical is recalling ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying enteral feeding and medication administration.

    Product
    Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube with Y-Port).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2531-2020·2020-07-15

    Philips M3015A Microstream CO2 Extension Recall for Incompatibility

    Philips is recalling M3015A Microstream CO2 Extensions because they are incompatible with IntelliVue X3 and MMX monitors, which may cause a loss of monitoring.

    Product
    Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2020·2020-07-15

    KCI ACTIV.A.C Therapy System Recalled for Unexpected Power Off

    KCI USA is recalling ACTIV.A.C Therapy Systems because they may power off without warning, stopping negative pressure wound therapy.

    Product
    ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2522-2020·2020-07-15

    United Imaging uCT 760 CT System Recalled for Image Artifacts

    Shanghai United Imaging Healthcare is recalling five uCT 760 CT systems due to intermittent image artifacts and scanning interruptions that may require patient rescans.

    Product
    uCT 760 System, Computed Tomography X-ray System
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2545-2020·2020-07-15

    Centurion Difficult IV Kit Recalled for False Carboxyhemoglobin Results

    Centurion Medical Products is recalling 140 Difficult IV Kits containing BD Vacutainer tubes that may cause false carboxyhemoglobin results.

    Product
    Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes 367884 & 367960; Centurion code 45177 (VACUTAINER GREEN TOP) and 84815 (VACUTAINER 3ML LT. GREEN). Centurion Kit Code: IV8860
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2532-2020·2020-07-15

    Bound Tree Medical Recalls Ambu King LTS-D Supraglottic Airway Kits

    Bound Tree Medical is recalling 167 Ambu King LTS-D Supraglottic Airway Kits because they contain an incompatible catheter-tip syringe that may prevent the airway balloon from inflating properly.

    Product
    Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu¿ King LTS-D" Supraglottic Airway Kit with ET Tube (hereafter the Kit which contains all of the components necessary to successfully obtain an open patient airway with an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2493-2020·2020-07-15

    Radiometer ABL800 FLEX Blood Gas Analyzers Recalled for Software Issues

    Radiometer Medical ApS is recalling ABL800 FLEX blood gas analyzers due to a software issue that creates a potential risk of patient mix-up.

    Product
    Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and…
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2515-2020·2020-07-15

    Kentec Medical Recalls ENFit Feeding Tubes Due to Cap Fracture Risk

    Kentec Medical is recalling 2,850 ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying patient care.

    Product
    Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-50P-50 (5 fr. 50 cm ENFit Enteral Feeding Tube).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2544-2020·2020-07-15

    Cardinal Health NPWT Canisters Recalled Due to Oversized O-Ring Defect

    Cardinal Health is recalling 1,960 NPWT Occlusion Detection Canisters because an oversized O-ring may prevent proper installation into the device connector.

    Product
    Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2439-2020·2020-07-08

    LivaNova SCP Pump Control Panel Recalled for Rotary Knob Wear

    LivaNova is recalling eight SCP Pump Control Panels because premature wear of the angle encoder may make the rotary knob difficult or impossible to rotate during cardiopulmonary bypass.

    Product
    Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-2408-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail, causing the device to stop working or fail to start.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2440-2020·2020-07-08

    LivaNova SCP Pump Control Panel Recalled Due to Rotary Knob Wear

    LivaNova is recalling 24 SCP Pump Control Panels because the rotary knob may fail to rotate due to premature wear, risking patient injury during surgery.

    Product
    Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: 04033817900986
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-2463-2020·2020-07-08

    LivaNova Recalls Vein Irrigation Cannulas Due to Sterile Barrier Breach

    LivaNova USA Inc. is recalling 150 units of Vein Irrigation Cannulas with blunt tips because internal tests identified potential breaches in the sterile barrier.

    Product
    Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-2415-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Component Failure

    Arrow International Inc is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a component issue that may cause the device to stop working.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2412-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International is recalling AutoCAT2 Intra-Aortic Balloon Pumps because a component may fail due to vibration, potentially causing the device to stop working.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2451-2020·2020-07-08

    LivaNova Recalls Sterile Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling 600 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-2413-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International Inc is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a component vibration issue that may cause the device to stop working.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2455-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-2411-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Component Vibration Failure

    Arrow International Inc. is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps because a component vibration issue may cause the device to stop working or fail to start.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2417-2020·2020-07-08

    Arrow AC3 Optimus Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International Inc is recalling AC3 Optimus Intra-Aortic Balloon Pumps because a component may fail due to vibration, potentially causing the device to stop working or fail to start.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2459-2020·2020-07-08

    LivaNova Recalls 220 Units of 3/8 Inch Y Connectors

    LivaNova USA Inc. is voluntarily recalling 220 units of 3/8 inch Y connectors due to a Class II defect.

    Product
    3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2462-2020·2020-07-08

    LivaNova Recalls Sterile Standalone Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 240 units of sterile standalone connectors because internal tests found potential breaches in the sterile barrier.

    Product
    1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2453-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2414-2020·2020-07-08

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Vibration Failure

    Arrow International Inc. is recalling 2,123 AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a component issue that may cause the device to stop working.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH, Product Code IAP-0500NL
    Category
    Medical Device
    Distribution
    0 states