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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19951–19975 of 40248

  • ModerateFDA (Devices)·Z-2237-2019·2019-08-21

    Santanello VAMPIRO V5001 Suction Sleeve Recalled for Package Integrity Issues

    Santanello Surgical LLC is recalling 98 VAMPIRO V5001 suction sleeves because package integrity issues may compromise sterility.

    Product
    VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2280-2019·2019-08-21

    Codman Galaxy G3 Mini Microcoil Delivery System Recalled for Labeling Error

    Codman & Shurtleff Inc is recalling 28 units of the Galaxy G3 Mini Microcoil Delivery System because the label displays the incorrect coil length.

    Product
    GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2277-2019·2019-08-21

    SunTech Medical Recalls Mislabeled Neonate Blood Pressure Cuffs

    Suntech Medical is recalling 80 neonate blood pressure cuffs because size #3 cuffs were packaged with size #4 labels.

    Product
    SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2283-2019·2019-08-21

    Luminex ARIES HSV 1&2 Assay Recalled for Seal Defects

    Luminex is recalling ARIES HSV 1&2 Assay kits because side cassette seals did not meet specifications, potentially affecting test sensitivity and stability.

    Product
    ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-2286-2019·2019-08-21

    Luminex ARIES Group A Strep Assay Recalled for Seal Defects

    Luminex is recalling ARIES Group A Strep Assay kits because side cassette seals may not meet specifications, potentially affecting test sensitivity and stability.

    Product
    ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-2231-2019·2019-08-21

    Zimmer Biomet Recalls Orthopedic Salvage System Hybrid Poly Tibia Components

    Zimmer Biomet is recalling 29 Orthopedic Salvage System Hybrid Poly Tibia units because cleaning processes may be ineffective. The recall covers units distributed in the US, Japan, and the Netherlands.

    Product
    Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2288-2019·2019-08-21

    Luminex ARIES Extraction Kit Recalled for Partially Sealed Cassette Assemblies

    Luminex Corporation is recalling ARIES Extraction Kits because partially sealed side cassette assemblies may reduce assay sensitivity and stability.

    Product
    ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-2073-2019·2019-08-14

    St Jude Medical Recalls 21 Ellipse DR Implantable Cardioverter Defibrillators

    St Jude Medical is recalling 21 Ellipse DR implantable cardioverter defibrillators due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.

    Product
    ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2074-2019·2019-08-14

    St Jude Medical Recalls 15 Ellipse DR Cardioverter Defibrillators

    St Jude Medical is recalling 15 Ellipse DR cardioverter defibrillators due to damaged aluminum wires that may prevent high-voltage therapy delivery.

    Product
    ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2072-2019·2019-08-14

    St Jude Medical Recalls Ellipse VR Cardioverter Defibrillators Due to Electrical Failures

    St Jude Medical is recalling 52 Ellipse VR cardioverter defibrillators worldwide due to damaged aluminum wires that may prevent high-voltage therapy delivery.

    Product
    ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2204-2019·2019-08-14

    Ad-Tech Recalls Non-Sterile Anchor Bolts for Depth Electrodes

    Ad-Tech Medical Instrument Corporation is recalling 201 non-sterile anchor bolts distributed without regulatory clearance or validated sterilization instructions.

    Product
    LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 21mm anodized anchor bolt body with anchor bolt cap containing a blue gasket and silicone cap, 13mm non-anodized anchor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2168-2019·2019-08-14

    Centurion Medical Recalls High Drainage LVAD Tray Kits Due to Packaging Concerns

    Centurion Medical Products Corporation is recalling 192 High Drainage LVAD Tray Kits because sterile packaging may be compromised.

    Product
    HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2075-2019·2019-08-14

    St Jude Medical Recalls 42 Ellipse DR Cardioverter Defibrillators

    St Jude Medical is recalling 42 Ellipse DR cardioverter defibrillators due to damaged aluminum wires that may prevent high-voltage therapy delivery.

    Product
    ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2228-2019·2019-08-14

    Intellijoint G2 Workstation Recalled Due to MacBook Pro Fire Risk

    Intellijoint Surgical is recalling 23 G2 Workstations because the Apple MacBook Pro components may overheat and pose a fire safety risk.

    Product
    Workstation, G2, Configured (P/N 000-0241)
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-2219-2019·2019-08-14

    Ideal Implant Recalls Structured Saline Breast Implants Due to Deflation

    Ideal Implant Incorporated is recalling 1,704 structured saline breast implants because a silicone piece disrupted the valve seal, causing deflation shortly after implantation.

    Product
    IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 440cc, 475cc, 515cc, 555cc, 595cc, 635cc, and 675cc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2070-2019·2019-08-14

    St Jude Medical Recalls 27 Ellipse VR Implantable Cardioverter Defibrillators

    St Jude Medical is recalling 27 Ellipse VR implantable cardioverter defibrillators due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.

    Product
    ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2071-2019·2019-08-14

    St Jude Medical Recalls 47 Ellipse VR Implantable Cardioverter Defibrillators

    St Jude Medical is recalling 47 Ellipse VR ICDs worldwide due to damaged aluminum wires that may prevent the delivery of high-voltage therapy.

    Product
    ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2155-2019·2019-08-14

    SenTec Membrane Changer Set Recalled for Potential Electrolyte Application Failure

    SenTec AG is recalling 3 sets of Membrane Changer Sets because there is a 5% chance of insufficient electrolyte application during sensor changes.

    Product
    SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2019·2019-08-14

    Comet Technologies Recalls YXLON Cougar Cabinet X-Ray Systems

    Comet Technologies is recalling 93 YXLON Cougar Cabinet X-Ray Systems because the door interlocks fail to meet federal performance standards for power disconnection.

    Product
    YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2137-2019·2019-08-14

    MED-EL SONATAti100 Cochlear Implant Recall for Leak Test Failures

    MED-EL is recalling 10 SONATAti100 cochlear implants because they failed helium-fine leak tests. The devices were distributed despite not meeting specifications.

    Product
    MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard Product Usage: The SONATATIi100 Implant is an implantable part of the MED EL Cochlear Implant…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2220-2019·2019-08-14

    ROi Recalls Custom Surgical Packs Containing Stryker Pneumosure Tubesets

    ROi Consolidated Service Center is recalling 261 custom surgical packs containing Stryker Pneumosure tubesets that may detach from the cassette, potentially causing gas leaks.

    Product
    Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2093-2019·2019-08-14

    Gk Photonics Atom Laser Projection Series Recalled for Safety Compliance

    Gk Photonics Inc is recalling the Atom Laser Projection Series because the provided remote interlock dongle does not fully comply with FDA manual reset requirements, posing a risk of high-power laser exposure.

    Product
    Atom Laser Projection Series
    Category
    Medical Device
    Distribution
    0 states