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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13651–13675 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-1889-2021·2021-06-23

    Medtronic perfusion system tubing packs recalled due to weld defects

    Medtronic is recalling specific lots of CB7J98R7 Custom Pack perfusion system tubing because some units may have insufficient or incomplete welds. The defect could affect device performance during cardiac surgery.

    Product
    Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1871-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled Due to Weld Defects

    Medtronic is recalling specific lots of HY10Z48R2 Adult ECC Custom Perfusion System tubing packs due to potential weld defects. Affected units may have insufficient or incomplete welds that could compromise device function.

    Product
    Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.
    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-1858-2021·2021-06-23

    Medical Device Analyzer Spare Parts Recalled for Internal Clock Defect

    Radiometer Medical ApS recalls E3800 PC Units spare parts due to an internal clock defect affecting analyzers. Approximately 965 units have been distributed worldwide, with 35 in the United States.

    Product
    E3800 PC Units (spare parts)
    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-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-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-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-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-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-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-1879-2021·2021-06-23

    Medtronic Perfusion System Tubing Packs Recalled for Insufficient Welds

    Medtronic Perfusion System tubing packs are recalled due to manufacturing defects involving insufficient or incomplete welds in the CB10W63R1 lot. Affected devices may malfunction during use.

    Product
    Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, 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-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
  • HighFDA (Devices)·Z-1851-2021·2021-06-23

    Hip prosthesis components recalled for mislabeling with incorrect sizes and types

    Corin TriFit hip prosthesis components from lot 467881 were mislabeled, with size 2 stems labeled as size 7 and vice versa. Surgeons could implant incorrect components during hip replacement surgery.

    Product
    Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1856-2021·2021-06-23

    Radiometer ABL90 FLEX Analyzer Recalled Due to Internal Clock Malfunction

    Radiometer Medical ApS is recalling ABL90 FLEX Analyzers with E3800 PC units due to an internal clock issue. Approximately 3,346 units are affected globally, with only 2 in the United States.

    Product
    Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
    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-1869-2021·2021-06-23

    HME for Tracheostomized Patients Recalled Due to Sterilization Process Deviations

    Covidien LP is recalling HME (Heat and Moisture Exchanger) units for tracheostomized patients due to potential deviations from validated ethylene oxide sterilization parameters. The recall affects 10,890 units distributed worldwide and in specific U.S. states.

    Product
    HME for Tracheostomized Patients, Item Code 353S13046 - 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
  • 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-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
  • 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-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-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