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 deaths or serious injuries are reported, 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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13626–13650 of 13836

  • HighFDA (Devices)·Z-1882-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Weld Defects

    Medtronic is recalling perfusion system tubing packs due to manufacturing defects involving incomplete or insufficient welds. No injuries have been reported, but the defect may affect product performance and safety.

    Product
    Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1880-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Defective Welds

    Medtronic is recalling specific lots of Custom Pack HY8R62R13 E Pack perfusion system tubing due to manufacturing defects. Affected lots may have incomplete welds that could compromise device function during use.

    Product
    Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2021·2021-06-23

    Medtronic Cardiac Perfusion Tubing Packs Recalled Due to Defective Welds

    Medtronic is recalling specific lots of CB4W67R20 Custom Perfusion System tubing packs due to incomplete welds that could affect system performance. The recall affects 61 packs distributed across nine states.

    Product
    Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1859-2021·2021-06-23

    Dialysate Concentrate for Hemodialysis Recalled for Out-of-Specification Formulation

    Medivators, Inc. recalls 1,381 cases of dialysate concentrate due to a manufacturing anomaly that may result in out-of-specification formulation. Affected lots may not function properly in hemodialysis treatment.

    Product
    Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1884-2021·2021-06-23

    Medtronic Custom Perfusion System Recalled for Incomplete Welds

    Specific lots of Medtronic's CB10W65R1 perfusion system tubing packs may have incomplete or insufficient welds that could compromise system integrity during cardiac surgery.

    Product
    Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1848-2021·2021-06-23

    Surgical Angio Pack Kits Recalled Due to Incomplete Angio Tubing Weld

    Windstone Medical Packaging is recalling Angio Pack surgical kits (Lot 146304 and 147534) due to angio tubing with insufficient or incomplete welds.

    Product
    Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS 2 Gown Surgical STD XLG NR 16 Label Custom 1 Counter Needle Nest 40 Sponge 4x4x12 plain 1 Syringe 10cc control polyc 1 Bag Band Dome 22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1895-2021·2021-06-23

    Medtronic Neonatal Perfusion System Tubing Sets Recalled for Incomplete Welds

    Medtronic is recalling 7 neonatal perfusion system tubing sets manufactured under lot 221387901 with insufficient or incomplete welds. The affected sets were distributed nationwide across nine states.

    Product
    Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1898-2021·2021-06-23

    VENOVO Venous Stent System 8F deployment failure during insertion

    The VENOVO Venous Stent System 8F may fail to expand properly upon deployment and remain connected to the delivery system, affecting approximately 12,258 devices worldwide including 7,234 in the United States.

    Product
    VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040 /Venovo 8F 10/40/1200mm OUS; VENEL10060 /Venovo 8F 10/60/1200mm OUS; VENEL10080 /Venovo 8F 10/80/1200mm OUS; VENEL10100 /Venovo 8F 10/100/1200mm OUS; VENEL10120 /Venovo 8F 10/120/1200mm OUS; VEN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1855-2021·2021-06-23

    WorkMate Claris v.1.2 Upgrade Kits Software Error Causes Function Loss

    WorkMate Claris v.1.2 Upgrade Kits may lose functionality or display a black screen during operation due to a software error.

    Product
    WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1894-2021·2021-06-23

    Medtronic Perfusion Tubing Packs Recalled for Insufficient or Incomplete Welds

    Medtronic is recalling specific lots of BB9G78R8 ECC perfusion system tubing packs due to insufficient or incomplete welds that may compromise device integrity.

    Product
    Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1867-2021·2021-06-23

    Mechanical respiratory filter recalls due to sterilization process deviation

    Covidien, LP is recalling a mechanical respiratory filter (Item 351/5979) due to potential deviations in ethylene oxide sterilization. The product was distributed worldwide and in multiple U.S. states.

    Product
    Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1878-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Weld Defects

    Medtronic is recalling specific lots of CB1H18R20 Custom Perfusion System tubing packs because they may have been manufactured with insufficient or incomplete welds. No injuries have been reported.

    Product
    Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1852-2021·2021-06-23

    Hydrodissection Cannula Recall Due to Residue at Tip

    Anodyne Surgical has recalled hydrodissection cannulas due to a possible yellowish-brown or greenish-brown residue on the tip. The affected devices were distributed in multiple US states and Canada.

    Product
    Hydrodissection Cannula (Chang), 27g, labeled as: anodynesurgical, REF 7018 ASICO, REF AS-7638 anodynesurgical, REF 7018NS katena, REF K20-3168 anodynesurgical, REF 104910 MSI, REF CA7800 ACCUTONE, REF AX14784-BULK Walcott Rx Products, REF RX2300NS Walcott Rx Products,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1868-2021·2021-06-23

    Covidien Respiratory Filters Recalled for Sterilization Process Deviations

    Covidien is recalling Adult-Pediatric Electrostatic Filter HMEs due to potential deviations in ethylene oxide sterilization parameters. Approximately 192,000 units were distributed worldwide.

    Product
    Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds

    Medtronic is recalling specific lots of BB11J14R2 Bridge Custom Perfusion System tubing packs due to incomplete or insufficient welds that may have occurred during manufacturing.

    Product
    Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1890-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds

    Medtronic is recalling HY10L28R3 perfusion system tubing packs (lot 221679870) manufactured with insufficient or incomplete welds. The recall affects units distributed in nine U.S. states.

    Product
    Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1897-2021·2021-06-23

    VENOVO Venous Stent System Recalled for Deployment Malfunction

    The FDA is recalling VENOVO Venous Stent System units due to reports that the proximal end may fail to expand immediately upon deployment and remain connected to the delivery catheter.

    Product
    VENOVO Venous Stent System 10F Product Description(REF)/dimension: VENEL16040 Venovo 10F 16/40/1200mm OUS VENEL16060 Venovo 10F 16/60/1200mm OUS VENEL16080 Venovo 10F 16/80/1200mm OUS VENEL16100 Venovo 10F 16/100/1200mm OUS VENEL16120 Venovo 10F 16/120/1200mm OUS VENEL16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1849-2021·2021-06-23

    Angio Pack surgical kits recalled for insufficient welds in tubing

    Windstone Medical Packaging is recalling Angio Pack surgical kits containing angio tubing with incomplete or insufficient welds that may fail during use. The recall affects 190 units; no injuries have been reported.

    Product
    Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1 Cover Probe 6 X 48 NS 2 Gown surgical STD XLG NR 1 Needle RB 18x1.5 1 Spike Bag Decanter 2 Syringe 20CC L/L 1 Utility Marker Permanent U 1 Bowl Denture Cup 8 oz
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1862-2021·2021-06-23

    Better-Bladder ECMO Device May Collapse, Reducing Blood Flow

    The Better-Bladder ECMO device used in cardiopulmonary bypass circuits may collapse during use, increasing venous line resistance and reducing blood flow. The recall affects 147 units distributed nationwide.

    Product
    The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1883-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds

    Medtronic is recalling 14 tubing packs of its HY10J00R12 perfusion system due to insufficient or incomplete welds. The affected lot is 221227814 with a use-by date of August 28, 2022.

    Product
    Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1899-2021·2021-06-23

    VENOVO 9F Venous Stent System incomplete deployment and delivery system retention

    Bard Peripheral Vascular recalls VENOVO Venous Stent System 9F due to reports that the proximal end fails to expand immediately upon deployment and remains connected to the delivery system.

    Product
    VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040 /Venovo 9F 14/40/1200mm OUS; VENEL14060 /Venovo 9F 14/60/1200mm OUS; VENEL14080 /Venovo 9F 14/80/1200mm OUS; VENEL14100 /Venovo 9F 14/100/1200mm OUS; VENEL14120 /Venovo 9F 14/120/1200mm OUS; VEN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1854-2021·2021-06-23

    Cardiac Monitoring System Software Error May Disable Device

    Abbott's WorkMate Claris cardiac monitoring system (Model H700124) is being recalled due to a software error that may disable the system or turn the screen black. Nine units affected in Michigan, Kansas, Missouri, and Texas.

    Product
    v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1864-2021·2021-06-23

    GE Healthcare X-Ray Systems Affected by Display Image Distortion Defect

    GE Healthcare interventional x-ray imaging systems can develop a display defect that splits and distorts live monitor images into two unequal parts. The defect affects 139 devices with worldwide distribution.

    Product
    GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1893-2021·2021-06-23

    Medtronic Custom Perfusion System Tubing Packs Recalled Due to Welding Defects

    Medtronic is recalling 26 tubing packs from its Custom Perfusion System (Lot 221148857) due to potential manufacturing defects. Specific lots may have been manufactured with insufficient or incomplete welds.

    Product
    Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Incomplete Welds

    Medtronic is recalling specific lots of BB10R94R6 Custom Perfusion System tubing packs due to incomplete or insufficient welds. The defect may affect device performance during use.

    Product
    Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide