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 13802

  • HighFDA (Devices)·Z-1896-2021·2021-06-23

    OSSUR Miami J Select Collar Recalled for Deforming Height-Adjustment Racks

    Ossur Americas is recalling the MIAMI J SELECT COLLAR cervical spine device due to deforming racks that may reduce immobilization. About 10,469 units were distributed nationwide.

    Product
    OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1891-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Weld Defects

    Medtronic is recalling specific lots of CB10Y89R10 custom perfusion system tubing packs due to insufficient or incomplete welds. The affected lots were distributed in nine U.S. states.

    Product
    Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.
    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-1887-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Defective Welding

    Medtronic has recalled 16 tubing packs from its CB10R79R6 Custom Perfusion System due to insufficient or incomplete welds in specific lots. The defect may compromise device integrity during use.

    Product
    Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1872-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled Due to Weld Defects

    Medtronic recalls specific lots of HY8M63R4 Adult ECC Custom Perfusion System tubing packs due to potentially insufficient or incomplete welds, which could affect performance during surgical procedures.

    Product
    Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1888-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Defective Welds

    Medtronic is recalling CB10R55R5 perfusion system tubing packs due to insufficient or incomplete welds that could compromise device function. The recall affects five tubing packs distributed across nine U.S. states.

    Product
    Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx.
    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-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-1875-2021·2021-06-23

    Medtronic Custom Perfusion System Tubing Packs Recalled for Incomplete Welds

    Medtronic recalls Custom Perfusion System tubing packs due to incomplete welds in the manufacturing process that may affect device integrity.

    Product
    Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1876-2021·2021-06-23

    Medtronic Custom Perfusion System Tubing Packs Recalled for Weld Defects

    Medtronic recalls custom perfusion system tubing packs due to potential manufacturing defects in welds. Specific lots may have insufficient or incomplete welds that could affect system integrity.

    Product
    Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1865-2021·2021-06-23

    ACUVUE VITA soft contact lenses recalled for potentially incomplete packaging seals

    Johnson & Johnson Vision Care is recalling certain ACUVUE VITA soft contact lenses due to potential incomplete packaging seals. Only a limited number of packages from LOT # BOOWWWL are affected.

    Product
    ACUVUE VITA soft (hydrophilic) contact lens (spherical) for daily wear. Base Curve 8.8, Refractive Power -1.50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1786-2021·2021-06-16

    Medical Convenience Kits Recalled Due to Mold Contamination Risk

    Avid Medical is recalling 160 fistula care kits due to potential contamination from Aspergillus penicillioides fungal growth in a component applicator. The contamination could breach the kit's package integrity and affect other sterile components.

    Product
    FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1785-2021·2021-06-16

    Avid Medical Fistula On-Off Kit Recalled for Potential Fungal Contamination

    Avid Medical is recalling 720 Fistula On-Off Kits due to potential fungal contamination that may compromise package integrity. The BD ChloraPrep applicator component may develop Aspergillus penicillioides, which could contaminate other kit components.

    Product
    FISTULA ON-OFF KIT. Medical convenience kit, Avid Medical Part Number: MMTN020.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1832-2021·2021-06-16

    DeRoyal Pacemaker Tray Mislabeled With Wrong Anesthetic Concentration

    DeRoyal is recalling surgical procedure packs due to mislabeling. The product contains 0.5% Bupivacaine but is labeled as 1% Lidocaine, creating a medication identification error.

    Product
    DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1833-2021·2021-06-16

    DeRoyal Heart Cath Procedure Packs Recalled for Anesthetic Mislabeling

    DeRoyal Industries is recalling 66 heart catheterization procedure packs due to mislabeling of anesthetic contents. The packs contain 0.5% Bupivacaine but are labeled as containing 1% Lidocaine, creating a medication error risk during surgery.

    Product
    DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1834-2021·2021-06-16

    Surgical procedure pack anesthetic mislabeled with wrong drug and strength

    DeRoyal Angio Cath Removal Tray contains mislabeled anesthetic; the label indicates 1% Lidocaine but the tray actually contains 0.5% Bupivacaine. This FDA Class I recall affects 60 trays distributed in MS, VA, LA, and NY.

    Product
    DeRoyal Angio Cath Removal Tray, REF 89-9936.02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1538-2021·2021-06-16

    INNOVA SARS-CoV-2 Antigen Rapid Tests Recalled for Unauthorized Non-Clinical Distribution

    INNOVA Medical Group is recalling SARS-CoV-2 antigen rapid test kits distributed to customers not enrolled in an authorized clinical investigation.

    Product
    For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1787-2021·2021-06-16

    Dialysis access kits recalled for potential fungal contamination risk

    Avid Medical is recalling medical dialysis access kits due to potential fungal growth in an applicator component that may compromise the package seal and contaminate other components. Approximately 560 kits distributed nationwide are affected.

    Product
    DIALYSIS ACCESS Medical convenience kit, Avid Medical Part Number: VMED004-03.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1537-2021·2021-06-16

    FDA Recalls Innova COVID-19 Self-Test Kits Due to Unauthorized Distribution

    Innova Medical Group is recalling COVID-19 self-test kits distributed to customers outside an authorized clinical investigation. The recall affects 370 boxes of tests distributed nationwide and internationally.

    Product
    COVID-19 Self-Test Kit *** INNOVA *** 7T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1539-2021·2021-06-16

    COVID-19 Self-Test Kit Distributed Without Clinical Investigation Authorization

    Innova Medical Group recalled COVID-19 self-test kits distributed to customers outside of clinical investigation requirements. About 1,206 tests in 402 boxes were distributed across the U.S., Canada, India, and the United Kingdom.

    Product
    COVID-19 Self-Test Kit *** INNOVA *** 3T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1798-2021·2021-06-16

    Jelco Insulin Syringe Graduation Markings Recalled for Skew Defect

    Smiths Medical recalls 1,432,200 Jelco insulin syringes with skewed graduation markings that could lead to incorrect dosing. Specific lot numbers are affected.

    Product
    JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1784-2021·2021-06-16

    Adult Chest Tube Tray Recalled Due to Package Integrity Risk

    Avid Medical is recalling 130 Adult Chest Tube Trays due to potential contamination from mold growth in a component. The BD ChloraPrep applicator may grow Aspergillus penicillioides, which could breach package integrity and contaminate other kit components.

    Product
    ADULT CHEST TUBE TRAY. Medical convenience kit, Avid Medical Part Number: LAKC001-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1799-2021·2021-06-16

    Alphatec Insignia Anterior Cervical Plate System screw failure recalled

    Alphatec is recalling its Insignia Anterior Cervical Plate System due to potential screw blocking mechanism failure during or after spinal surgery. The screw may disassociate intraoperatively or unlock postoperatively.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0116, Insignia, ACP, 1-Level, 16 mm, Rx Only, Non-Sterile, UDI: (01)00190376268422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2021·2021-06-16

    Medical Device Software Defects in RayStation Treatment Planning System

    RayStation radiation therapy treatment planning software versions 6 through 10A contain defects that may cause misleading dose evaluations and contouring errors. Healthcare facilities should verify treatment plans and contact the manufacturer for guidance.

    Product
    RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 or 10.1.0.613 .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2021·2021-06-16

    Alphatec Insignia Cervical Plate System Screw Locking Mechanism May Disassociate or Unlock

    Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569
    Category
    Medical Device
    Distribution
    Distributed nationwide