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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9476–9500 of 39932

  • SevereFDA (Devices)·Z-2140-2023·2023-08-02

    HAMILTON T1 Ventilator software defect may cause unexpected shutdown

    Hamilton Medical is recalling 2,319 HAMILTON T1 Ventilators due to a software anomaly that may cause the device to stop and enter ambient mode after approximately 91 days of use.

    Product
    HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-2141-2023·2023-08-02

    Hamilton C2 Ventilator recalled for software anomaly causing loss of function

    FDA is recalling 399 Hamilton C2 Ventilators due to a software anomaly that may cause the device to stop unexpectedly after approximately 91 days of use. Affected facilities should verify serial numbers and contact the manufacturer.

    Product
    HAMILTON C2 Ventilator Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-2142-2023·2023-08-02

    Hamilton C3 ventilator software anomaly may cause unexpected device stoppage

    A software anomaly in the Hamilton C3 Ventilator may cause it to unexpectedly stop and enter ambient mode without warning after approximately 91 days of use. Approximately 701 systems are affected.

    Product
    HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-2139-2023·2023-08-02

    HAMILTON C1 Ventilator Recalled for Software Defect Causing Unexpected Shutdown

    Hamilton Medical is recalling 689 HAMILTON C1 Ventilators due to a software defect that causes unexpected shutdown after approximately 91 days of use. The device may enter ambient mode without notice, interrupting ventilatory support.

    Product
    HAMILTON C1 Ventilator REF 161001 1610010 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-2234-2023·2023-08-02

    Laser fiber medical devices recalled for potential burn injury hazard

    Boston Scientific recalls Flexiva Pulse laser fibers due to manufacturing defects that can cause fiber connector overheating and potential burns if touched. Affects 280 units in US and Canada.

    Product
    Flexiva Pulse ID 242 TracTip single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy 5-pack UPN: M006L8406961
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2241-2023·2023-08-02

    Hernia repair implant balloon may not inflate as intended

    Davol's Ventralight ST hernia repair implant balloon may fail to inflate properly during laparoscopic surgery. This could result in procedure delay, inadequate mesh placement, and risk of infection.

    Product
    Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2215-2023·2023-08-02

    Respiratory diagnostic panel fails to produce test results

    Qiagen's QIAstat-Dx Respiratory SARS-CoV-2 Panel may fail to produce diagnostic results due to software errors in affected cartridges. Test runs will abort with error codes, leaving no test results available.

    Product
    QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapn
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2227-2023·2023-08-02

    Flexible Laryngeal Mask Airway Packs Lack Required Expiration Date Labels

    Medline Industries is recalling 9,945 DYND3000xxP Series laryngeal mask airway packs because the case and packet labels are missing expiration dates. Without this information, users cannot determine product validity.

    Product
    DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2231-2023·2023-08-02

    Flexiva Pulse ID Laser Fiber Recalled for Incorrect Component

    Boston Scientific is recalling Flexiva Pulse ID laser fibers due to an incorrect component that reduces power output and aiming beam brightness. The component can overheat, risking burns to users who touch the fiber connector.

    Product
    Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN: M006L8406910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2230-2023·2023-08-02

    Laser Fiber Devices May Overheat and Cause Burns During Use

    Boston Scientific is recalling Flexiva Pulse 242 laser fibers due to manufacturing defects that may cause the fiber connector to overheat and cause burn injuries. The recall affects 1,245 units distributed in the US and Canada.

    Product
    Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. 5-pack UPN: M006L8405961
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2023·2023-08-02

    Argon Medical Option Elite Vena Cava Filter Recall Due to Performance Risk

    Argon Medical Devices is recalling 3 Option Elite Retrievable Vena Cava Filters due to a potential performance defect that could result in pulmonary embolism. Affected units were distributed in Texas.

    Product
    Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2243-2023·2023-08-02

    Ventral Hernia Mesh Balloon May Fail to Inflate During Surgery

    A surgical mesh implant used in ventral hernia repair may fail to inflate properly during the procedure, potentially causing inadequate placement and infection risk. The manufacturer is recalling 169 units worldwide.

    Product
    Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU on
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2238-2023·2023-08-02

    FRED Flow Re-Direction Endoluminal Device recalled for incorrect inner stent length

    The FDA is recalling FRED Flow Re-Direction Endoluminal Devices due to a manufacturing defect that may result in incorrect inner stent length, potentially affecting device performance. 474 units were affected.

    Product
    FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA, FRED3524-PMA, FRED3536-CA, FRED3536-PMA, FRED4007-PMA, FRED4012-CA, FRED4012-PMA, FRED4017-PMA, FRED4026, FRED4026-PMA, FRED4038-PMA, FRED4508,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2023·2023-08-02

    Flexiva Pulse ID Laser Fiber Recalled for Potential Burn Hazard

    Boston Scientific recalls Flexiva Pulse ID laser fibers used in urological procedures due to a manufacturing defect that may cause connector overheating and burns. The recall affects 205 units distributed in the US and Canada.

    Product
    Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Box of 5)UPN: M006L8406911
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2236-2023·2023-08-02

    Trexo Device recalled due to electrical hazards and burn risk

    Trexo Robotics is recalling the Trexo Device due to electrical issues that could cause burns, device malfunction, and electromagnetic interference with other equipment. Consumers should stop using affected devices.

    Product
    Trexo Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2228-2023·2023-08-02

    Flexiva Pulse 242 Laser Fibers Recalled Due to Overheating Risk

    Boston Scientific is recalling Flexiva Pulse 242 Single-Use Laser Fibers due to manufacturing defects that reduce power output and aiming beam visibility, risking fiber connector overheating and potential burns.

    Product
    Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Single-pack UPN : M006L8405910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2229-2023·2023-08-02

    Flexiva Pulse 242 Laser Fibers Recalled Due to Overheating Risk

    Boston Scientific's Flexiva Pulse 242 TracTip laser fibers may overheat during use due to a manufacturing defect, posing a burn risk. Affected units should not be used.

    Product
    Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Single-pack UPN : M006L8405960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2242-2023·2023-08-02

    Hernia repair mesh balloon may not inflate during surgery

    Davol Ventralight ST hernia repair mesh balloons may fail to inflate during surgery, potentially causing inadequate mesh placement, infection, and procedure delays.

    Product
    Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2237-2023·2023-08-02

    Beckman Coulter Recalls DxI Reaction Vessels Due to Inaccurate Test Results

    Beckman Coulter is recalling over 2 million Ringed DxI Reaction Vessels that may produce falsely elevated lab test results due to interior surface defects. The issue was discovered through internal service testing.

    Product
    Ringed DxI Reaction Vessels (RVs)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2245-2023·2023-08-02

    Respiratory Diagnostic Test Kits Recalled for Decreased Performance Reliability

    Qiagen's QIAstat-Dx Respiratory SARS-CoV-2 Panel diagnostic kits are recalled due to decreased performance reliability. Failed test runs could require sample retesting, potentially delaying diagnosis.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2240-2023·2023-08-02

    Mobile X-ray System with Faulty Glue Assembly May Pose Electric Shock Hazard

    Siemens Mobile X-ray systems may have incorrect glue on the tank cover assembly, which could fall off and allow liquid ingress, creating electric shock risk. The recall affects 9 units distributed in the US and internationally.

    Product
    Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. Material #11515088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2244-2023·2023-08-02

    Surgical mesh inflation malfunction in Ventralight ST hernia repair device

    Davol's Ventralight ST surgical mesh may fail to inflate properly during laparoscopic hernia repair, potentially causing inadequate mesh placement and infection.

    Product
    Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955460G (EU On
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2023·2023-08-02

    vRad PACS medical imaging system recalled for intermittent image display failures

    Virtual Radiologic's vRad PACS with Mammography system may intermittently fail to display radiology images, preventing radiologists from viewing diagnostic studies. Eight units across seven U.S. states are affected by this Class II recall.

    Product
    vRad PACS with Mammography
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2233-2023·2023-08-02

    Flexiva Pulse Laser Fiber Recalled Due to Burn Hazard from Incorrect Component

    Boston Scientific is recalling Flexiva Pulse 242 ID Trac laser fibers with incorrect components that may overheat and cause burns if touched during use.

    Product
    Flexiva Pulse 242 ID Trac Single Use Fiber-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (Single-pack UPN): M006L8406960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2246-2023·2023-08-02

    COVID-19 Diagnostic Test Kits Recalled Due to Performance Reliability Issues

    Qiagen has recalled 4155 QIAstat-Dx Respiratory SARS-CoV-2 Panel kits due to decreased performance reliability. Test failures (run abortions) may require samples to be retested, potentially delaying diagnosis.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the US.) Qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection REF: 691214
    Category
    Medical Device
    Distribution
    14 states