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.

Filters

Agency

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

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

16726–16750 of 39988

  • ModerateFDA (Devices)·Z-2496-2020·2020-07-15

    Tomtec ARENA TTA2 Software Recalled for Potential Data Storage Error

    Tomtec Imaging Systems is recalling ARENA TTA2 software versions 2.20 and lower because measurements from one study might be stored to another.

    Product
    TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement…
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-2498-2020·2020-07-15

    CooperSurgical Recalls Mislabeled Os Finder Cervical Dilators

    CooperSurgical is recalling 2,250 Os Finder Cervical Dilators due to mislabeled blister trays. The product inside is correct, but the packaging label is incorrect.

    Product
    COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2509-2020·2020-07-15

    Medtronic Azure XT SR MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 31,736 Azure XT SR MRI devices due to a rare communication issue that temporarily suspends certain device features.

    Product
    Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2511-2020·2020-07-15

    Medtronic Percepta CRT-P MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 37,360 Percepta CRT-P MRI devices due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2540-2020·2020-07-15

    FHC Guideline 4000 5.0 Main Processing Unit Recalled for Electrical Defect

    FHC, Inc. is recalling six Guideline 4000 5.0 Main Processing Units because an electrical sub-circuit was not properly connected, potentially affecting performance during ESD events.

    Product
    FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 00873263006740
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2510-2020·2020-07-15

    Medtronic Azure S SR MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 11,953 Azure S SR MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Azure S SR MRI, Model Number W3SR01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2543-2020·2020-07-15

    Cardinal Health NPWT Canisters Recalled for Oversized O-Ring Defect

    Cardinal Health is recalling 3,000 NPWT Canisters with Gel 300cc because they may contain an oversized O-ring that cannot be installed.

    Product
    Cardinal Health NPWT Canister with Gel 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 grafts. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2535-2020·2020-07-15

    Laborie Pump Tube Sets Recalled for Damaged Packaging Seals

    Laborie Medical Technologies is recalling 480 Pump Tube Sets due to damaged packaging seals that may compromise product integrity.

    Product
    Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic procedures to study the function of the bladder and urethra during filling and voiding, by monitoring pressure and pressure changes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2538-2020·2020-07-15

    OrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors

    OrthoPediatrics Corp is recalling 9 units of ShieldLoc 6mm implant components because some packages contain the wrong size.

    Product
    OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2525-2020·2020-07-15

    TeDan 3COR Distraction Screw Recall Due to Pouch Seal Defect

    TeDan Surgical Innovations is recalling 3COR Distraction Screws because the sterile pouch seal is defective, potentially compromising sterility.

    Product
    3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2508-2020·2020-07-15

    Medtronic Azure S DR MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 49,513 Azure S DR MRI devices because a rare communication issue may temporarily suspend certain device features.

    Product
    Azure S DR MRI, Model Number W3DR01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2533-2020·2020-07-15

    Teleflex Recalls RUSCH LASERTUBE Devices Due to Laser Guard Foil Separation

    Teleflex is voluntarily recalling 6,014 RUSCH LASERTUBE devices because the laser guard foil may partially separate or detach at the edges when exposed to moisture.

    Product
    RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070 e) I.D. mm 8,0, Product Code 102004-000080 Product…
    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