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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13351–13375 of 27500

  • HighFDA (Devices)·Z-2528-2020·2020-07-15

    TeDan Phantom CS Quick Start Distraction Screw Recall for Seal Defect

    TeDan Surgical Innovations LLC is recalling 730 sterile Phantom CS Quick Start Distraction Screws due to a lack of pouch seal.

    Product
    PHANTOM CS QUICK START 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-2497-2020·2020-07-15

    Ra Medical Systems Recalls DABRA Laser Due to Software Issue

    Ra Medical Systems is recalling 79 DABRA Laser units because a software issue could cause unintended laser light release, potentially injuring users or patients.

    Product
    DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to deliver the energy to the surgical site to ablate unwanted material. The…
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-2519-2020·2020-07-15

    Kentec Medical Recalls ENFit Feeding Tubes Due to Cap Fracture Risk

    Kentec Medical is recalling 70 ENFit feeding tubes because the plastic tethered closure cap may fracture, potentially delaying care or causing unnecessary radiation exposure.

    Product
    Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-Y50P-80 (5 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2492-2020·2020-07-15

    Prodimed Combicath Paediatric Catheters Recalled for Sterility Assurance Issues

    Prodimed is recalling Combicath Paediatric catheters due to a lack of assurance of sterility. The recall covers 2,580 units distributed nationwide.

    Product
    Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code: 58 223 19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2529-2020·2020-07-15

    TeDan Phantom CS Distraction Screw Recalled for Sterility Seal Defect

    TeDan Surgical Innovations LLC is recalling 495 Phantom CS Quick Start Distraction Screws because the pouch seal is lacking, compromising the sterile labeling.

    Product
    PHANTOM CS QUICK START 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
  • HighFDA (Devices)·Z-2520-2020·2020-07-15

    Kentec Medical Recalls ENFit Enteral Feeding Tubes Due to Cap Fracture Risk

    Kentec Medical is recalling 170 ENFit enteral 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-Y60P-80 (6 fr. 80 cm ENFit Enteral Feeding Tube with Y-Port).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2487-2020·2020-07-15

    Prodimed Combicath Catheters Recalled for Sterility Assurance Concerns

    Prodimed Plastimed Division is recalling 7,220 Combicath catheters for mini bronchoalveolar lavage due to a lack of assurance of sterility.

    Product
    Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2534-2020·2020-07-15

    Dufner De Bakey Slim Needleholder Recalled for Potential Tissue Injury

    Dufner Instrumente GmbH is recalling De Bakey Slim Needleholders because the tungsten carbide plate can break under pressure, potentially causing patient tissue injury.

    Product
    DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2523-2020·2020-07-15

    Philips EasyDiagnost Eleva DRF X-ray System Recalled for Power Supply Defect

    Philips is recalling 52 EasyDiagnost Eleva DRF X-ray systems because incorrectly installed thermo switches in the main power supply may cause malfunction.

    Product
    EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2020·2020-07-15

    Abbott Recalls TactiCath Quartz Contact Force Ablation Catheters Due to Data Loss

    Abbott is recalling TactiCath Quartz Contact Force Ablation Catheters because they may lose contact force information during use.

    Product
    TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2527-2020·2020-07-15

    TeDan Phantom CS Distraction Screw Recalled for Lack of Pouch Seal

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

    Product
    PHANTOM CS 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
  • HighFDA (Devices)·Z-2530-2020·2020-07-15

    TeDan Phantom CS Quick Start Distraction Screw Recall for Seal Defect

    TeDan Surgical Innovations LLC is recalling 340 sterile Phantom CS Quick Start Distraction Screws due to a lack of pouch seal.

    Product
    PHANTOM CS QUICK START DISTRACTION SCREW, 16 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-2524-2020·2020-07-15

    TeDan 3COR Distraction Screw Recall Due to Sterility Seal Failure

    TeDan Surgical Innovations LLC is recalling 3COR Distraction Screws because the pouch seal is lacking, compromising the sterile labeling.

    Product
    3COR 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-2516-2020·2020-07-15

    Kentec Medical Recalls ENFit Polyurethane and Silicone Feeding Tubes

    Kentec Medical is recalling 710 ENFit feeding tubes because the plastic tethered closure cap may fracture or break, potentially delaying care or increasing radiation exposure.

    Product
    Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-60P-50 (6 fr. 50 cm ENFit Enteral Feeding Tube).
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2546-2020·2020-07-15

    Cook Zenith Alpha Abdominal Endovascular Graft Recall for Damaged Bushing

    Cook Inc. is recalling 571 units of Zenith Alpha Abdominal Endovascular Grafts due to a potential damaged bushing that may prevent full deployment.

    Product
    Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2537-2020·2020-07-15

    Vitalconnect VistaSolution Software Recall for Missing SpO2 Notifications

    Vitalconnect Inc. is recalling VistaSolution software due to a defect that prevented low SpO2 alerts, potentially exposing patients to short-term hypoxia.

    Product
    VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data collected by the wireless remote monitoring system in healthcare settings. This is a secondary, adjunct patient monitor and is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2490-2020·2020-07-15

    Prodimed Combicath catheters recalled due to sterility assurance concerns

    Prodimed is recalling 1,460 Combicath catheters nationwide because the company cannot assure the products are sterile.

    Product
    Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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