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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16701–16725 of 39988

  • HighFDA (Devices)·Z-2517-2020·2020-07-15

    Kentec Medical Recalls ENFit Polyurethane and Silicone Feeding Tubes

    Kentec Medical is recalling 2,130 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-80P-50 (8 fr. 50 cm ENFit Enteral Feeding Tube).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2526-2020·2020-07-15

    TeDan Phantom CS Distraction Screw Recall for Lack of Pouch Seal

    TeDan Surgical Innovations LLC is recalling 1,965 Phantom CS Distraction Screws because the packaging lacks a pouch seal, compromising the sterile labeling.

    Product
    PHANTOM CS DISTRACTION SCREW, 12 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
  • HighFDA (Devices)·Z-2476-2020·2020-07-15

    Verathon Recalls GlideScope Core OneTouch Smart Cables Due to Connection Defect

    Verathon is recalling 437 GlideScope Core OneTouch Smart Cables because twisting during connection may damage the internal circuit board, causing video loss during critical intubation procedures.

    Product
    GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch Cables (Reusable Device) is ancillary equipment used with the Core 10 and Core 15 monitors. The monitor and workstation are intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2500-2020·2020-07-15

    XTANT Medical Recalls Irix-C Forceps Inserter Due to Fracture Risk

    XTANT Medical is recalling four Irix-C Forceps Inserters because the strike plate may fracture off due to unsatisfactory welds.

    Product
    Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2521-2020·2020-07-15

    United Imaging Recalls uDR 596i Digital Medical X-Ray Imaging Systems

    Shanghai United Imaging Healthcare is recalling six uDR 596i digital medical X-ray systems due to software errors that may cause incorrect anatomical positioning or loss of image tags, leading to additional radiation exposure.

    Product
    uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2514-2020·2020-07-15

    Kentec Medical Recalls ENFit Feeding Tubes Due to Cap Fracture Risk

    Kentec Medical is recalling 480 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-40P-50 (4 fr. 50 cm ENFit Enteral Feeding Tube).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2488-2020·2020-07-15

    Prodimed Combicath Catheters Recalled Due to Sterility Assurance Concerns

    Prodimed Plastimed Division is recalling Combicath catheters for mini bronchoalveolar lavage because of a lack of assurance of sterility.

    Product
    Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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