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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16851–16875 of 40124

  • 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
  • ModerateFDA (Devices)·Z-2513-2020·2020-07-15

    Medtronic Solara CRT-P MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 16,667 Solara CRT-P MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2506-2020·2020-07-15

    Medtronic Patient Connector Recall for Temporary Feature Suspension

    Medtronic is recalling 1,025 Patient Connectors because a rare communication error may temporarily suspend device features. The issue is unlikely to cause clinical impact and features restore automatically.

    Product
    Patient Connector, Model Number 24967
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2507-2020·2020-07-15

    Medtronic Azure XT DR MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 266,252 Azure XT DR MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2505-2020·2020-07-15

    Medtronic Recalls CareLink SmartSync Device Manager Due to Feature Suspension

    Medtronic is recalling 2,773 CareLink SmartSync Device Manager units worldwide because a rare communication error may temporarily suspend certain device features.

    Product
    CareLink SmartSync Device Manager, Model Number 24970A
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2536-2020·2020-07-15

    Capso Vision Recalls CapsoCam Plus Capsules Due to Data Recording Failure

    Capso Vision is recalling 82 CapsoCam Plus capsules because they fail to record data when ingested, potentially delaying diagnosis.

    Product
    The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2539-2020·2020-07-15

    OrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors

    OrthoPediatrics Corp is recalling 11 units of ShieldLoc 7mm implant components because some packages contain the wrong size product.

    Product
    OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - 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-2512-2020·2020-07-15

    Medtronic Serena CRT-P MRI Recall for Temporary Feature Suspension

    Medtronic is recalling 17,750 Serena CRT-P MRI devices worldwide due to a rare communication issue that may temporarily suspend certain device features.

    Product
    Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
    Category
    Medical Device
    Distribution
    0 states
  • 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