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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1301–1325 of 5111

  • SevereFDA (Devices)·Z-2382-2023·2023-08-23

    Mahurkar Dialysis Catheter Center Lumen Occlusion, FDA Class I Recall

    Covidien's Mahurkar dialysis catheters are recalled due to center lumen occlusion from excessive silicone lubricant, risking treatment delay and serious vascular complications.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2379-2023·2023-08-23

    Dialysis Catheters Recalled Due to Excessive Lubricant Causing Obstruction

    Covidien is recalling MAHURKAR dialysis catheters that may have excessive lubricant coating the catheter tip, potentially causing dangerous blockages that delay treatment or lead to serious complications.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2384-2023·2023-08-23

    Dialysis catheters recalled for potential center lumen obstruction

    Covidien LP is recalling MAHURKAR dialysis catheters because excessive silicone lubricant coats the center lumen, potentially blocking blood flow or creating clots and other blood vessel complications.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2369-2023·2023-08-23

    Dialysis Catheter Recalled Due to Silicone Lubricant Obstruction Risk

    Covidien LP is recalling 5,373 MAHURKAR dialysis catheters because excessive silicone lubricant can occlude the catheter lumen, potentially causing treatment delays or blood clotting complications.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2378-2023·2023-08-23

    Dialysis catheter recall: excessive lubricant causes center lumen obstruction

    A dialysis catheter product is being recalled due to excessive lubricant coating in the center lumen, which may cause full or partial obstruction. The blockage could delay treatment and increase risk of blood clots and hemolysis.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2380-2023·2023-08-23

    FDA Recalls Mahurkar Dialysis Catheter for Potential Tip Obstruction Risk

    Covidien's Mahurkar acute dialysis catheters may have excessive silicone lubricant causing tip obstruction. This could delay treatment or cause serious complications including blood clots and embolism.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2373-2023·2023-08-23

    Dialysis Catheter Recall Due to Potential Lumen Occlusion

    Covidien LP is recalling MAHURKAR dialysis catheters due to excess silicone lubricant that can block the central lumen, potentially delaying treatment or causing serious complications.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 8888103001HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2387-2023·2023-08-23

    Dialysis Catheters Recalled by FDA for Tip Obstruction Risk

    Covidien is recalling MAHURKAR acute dialysis catheters because the center lumen tip may be occluded by excessive silicone-based lubricant. Obstruction could delay treatment or cause embolism and thrombosis.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit REF: 8888345611HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2281-2023·2023-08-09

    Impella RP Flex cardiac pump recalled for thrombus formation risk

    The Impella RP Flex cardiac pump has been recalled due to a higher-than-expected rate of blood clot formation. Blood clots may reduce cardiac support or cause hemolysis.

    Product
    Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2221-2023·2023-08-02

    Datascope SENSATION PLUS Intra-Aortic Balloon Catheter Dilator Fracture Risk

    Datascope's SENSATION PLUS intra-aortic balloon catheter dilator may fracture during insertion, potentially damaging the femoral artery or aorta. The firm has received 10 complaints, including 3 serious adverse events and 1 patient death.

    Product
    SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 7.5Fr. 40c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2216-2023·2023-08-02

    Intra-Aortic Balloon Catheter Introducer Dilator Fracture During Insertion

    The YAMATO PLUS intra-aortic balloon catheter's introducer dilator may fracture during insertion, risking arterial damage, aortic damage, or blood clots. Datascope has received 10 complaints, including 1 death and 3 serious adverse events.

    Product
    YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description Part Number YAMATO PLUS-R 30cc IAB WITH ACCESSORIE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2217-2023·2023-08-02

    Datascope SENSATION 7 Intra-Aortic Balloon Catheters Recalled for Introducer Fracture Risk

    The SENSATION 7 Fr. intra-aortic balloon catheter introducer dilator may fracture during insertion, potentially damaging blood vessels and requiring surgery. One death has been reported among 10 total complaints.

    Product
    SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION 7 Fr. 34cc IAB WITH ACCESSORIES (CHINA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2222-2023·2023-08-02

    Intra-aortic balloon catheter recall due to introducer dilator fracture risk

    Datascope Corp. is recalling SENSATION PLUS 8Fr. intra-aortic balloon catheters because the introducer dilator may fracture during insertion, risking blood vessel damage and surgical intervention. The company received 10 complaints, including 1 death.

    Product
    SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 8Fr. 50cc I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2219-2023·2023-08-02

    Intra-Aortic Balloon Catheter kits recalled due to dilator fracture risk

    Datascope's MEGA 7.5Fr. intra-aortic balloon catheter kits may have introducers that fracture during insertion, risking arterial damage and embolization. The firm has received 10 complaints including 3 serious events and 1 death.

    Product
    MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 7.5Fr. 40cc IAB WITH ACCESSOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2224-2023·2023-08-02

    Intra-Aortic Balloon Catheter Introducer Set fracture causes vascular injury

    Datascope Corp. recalls Reinforced Introducer Sets because the dilator may fracture during catheter insertion, risking arterial damage and embolization. One patient death has been reported.

    Product
    REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number REINFORCED INTRODUCER SE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2220-2023·2023-08-02

    MEGA Intra-Aortic Balloon Catheter Introducer Fracture Poses Arterial Injury Risk

    Datascope's MEGA 8Fr. intra-aortic balloon catheter introducer may fracture during insertion, leaving fragments that can damage blood vessels. The firm has reported 10 complaints, including 1 death.

    Product
    MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number MEGA 8Fr. 50cc IAB WITH STATLOCK D68
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2218-2023·2023-08-02

    Intra-Aortic Balloon Catheter Introducer Dilator May Fracture During Insertion

    Datascope TRANS-RAY IAB catheters may have introducer dilators that fracture during insertion, risking arterial damage or blood clots. The firm reports 1 death and 3 serious injuries.

    Product
    TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number 7FR. 34cc TRANS-RAY IAB WITH ACCESSORIES D684-00-0545-01 TRANS-RAY 7FR. 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2223-2023·2023-08-02

    LINEAR intra-aortic balloon catheter introducer dilator fracture risk

    Datascope's LINEAR intra-aortic balloon catheters may develop a fractured introducer dilator that can injure blood vessels or cause dangerous blockages. The company has received 10 complaints including 1 death and 3 serious adverse events.

    Product
    LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number LINEAR 7.5Fr. 34cc IAB WITH ACCES
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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
  • 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
  • CriticalFDA (Devices)·Z-2016-2023·2023-07-26

    Olympus Bronchovideoscope Recalled for Endobronchial Combustion Risk

    Olympus is recalling 17,609 bronchovideoscope units nationwide due to complaints of endobronchial combustion during therapeutic laser procedures, which poses a fire and burn risk to patients.

    Product
    Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2014-2023·2023-07-26

    Olympus EVIS EXERA Bronchoscope Recalled for Combustion Risk During Laser Procedures

    The FDA recalls 284 Olympus EVIS EXERA bronchoscopes due to complaints of combustion during therapeutic laser procedures. Users should stop using affected models immediately.

    Product
    Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2150-2023·2023-07-26

    Intra-Aortic Balloon Pump may fail to charge batteries, interrupting therapy

    The Cardiosave Rescue Intra-Aortic Balloon Pump may lose battery charging ability in one or both bays, potentially interrupting therapy if disconnected from power. Low battery alarms may alert users before therapy stops.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide