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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201–225 of 1396

  • SevereFDA (Devices)·Z-0831-2025·2025-01-22

    Dialysis Blood Circuit May Cause Excessive Fluid Removal

    The AquaFlexFlow UF 500 Plus blood circuit may malfunction and remove excessive fluid from patients, causing a dangerous drop in blood volume. This risk is especially dangerous for pediatric patients.

    Product
    nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0822-2025·2025-01-22

    ACCOLADE DR Pacemakers Recalled for Unintended Safety Mode Activation

    Boston Scientific is recalling ACCOLADE DR Pacemakers built before September 2018 due to risk of unintended Safety Mode activation caused by battery impedance issues. The devices may enter Safety Mode during normal telemetry operations.

    Product
    ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0714-2025·2025-01-22

    Endoscopic Access Overtube Recalled for Risk of Obstruction and Pressure Buildup

    Trokamed is recalling a 20 Fr. endoscopic access overtube due to risk of obstruction and dangerous kidney pressure buildup during procedures. If inflow speed is too quick, rapid fluid flow can restrict outflow and cause intrarenal pressure to accumulate.

    Product
    Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0829-2025·2025-01-22

    Impella RP Heart Pump Recalled Due to Optical Sensor Damage Risk

    Abiomed is recalling 1,560 units of the Impella RP with SmartAssist pump due to risk of optical sensor damage from device interactions. Damaged sensors may cause temporary or permanent pump malfunction.

    Product
    Impella RP with SmartAssist; Product Number: 0046-0035;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0795-2025·2025-01-15

    Oxygen Concentrator May Catch Fire or Melt During Use

    The JMC5A Ni/TruAire-5 Oxygen Concentrator (Model O2C5L) is being recalled. The device may catch fire or melt during use, creating a risk of serious injury from fire and burns.

    Product
    JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0712-2025·2025-01-15

    Vasoview Hemopro 2 Vessel Harvesting System Recalled for Heater Wire and Silicone Defects

    Maquet Cardiovascular is recalling the Vasoview Hemopro 2 Vessel Harvesting System due to potential heater wire and silicone defects. These could affect device function during minimally invasive surgery.

    Product
    Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0711-2025·2025-01-15

    VasoView HemoPro 2 Endoscopic Vessel Harvesting System Class I Recall

    FDA recalls VasoView HemoPro 2 endoscopic vessel harvesting systems due to risk of heater wire detachment and silicone peeling from the harvesting tool jaws, which could affect device function.

    Product
    VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0763-2025·2025-01-15

    Large Volume Pump model LVP-0004 recalled for potential pneumatic valve failure

    Fresenius Kabi is recalling 1,520 Ivenix infusion pumps (model LVP-0004) due to potential pneumatic valve failure that may stop active infusions or prevent pump operation. Affected units were distributed to healthcare facilities in six U.S. states.

    Product
    Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0683-2025·2025-01-01

    Blood glucose ketone meter software bug causes erroneous result transmission

    Nova Biomedical's StatStrip glucose ketone hospital meter (Model 63910) has a software bug that may transmit erroneous results to healthcare systems. The issue affects 1,615 units distributed across the US and internationally.

    Product
    StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0708-2025·2025-01-01

    Cardiac Monitoring Software Failed to Properly Route ECG Events

    Braemar Manufacturing's Monitoring Service Application (versions 6.5-7.4) failed to properly route and review ECG events from July 2022-July 2024 due to a disabled analysis step. This affected about 130,000 units with 41,282 customers nationwide.

    Product
    Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0682-2025·2025-01-01

    Blood Glucose Ketone Meter Firmware Bug Causes Inaccurate Test Results

    Software bug in StatStrip Glucose Ketone Hospital Meter System can cause incorrect blood glucose and ketone test results to be transmitted to healthcare data systems. 347 units affected.

    Product
    StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0681-2025·2025-01-01

    Glucose Hospital Meter Software Bug Transmits Inaccurate Results

    StatStrip Glucose Hospital Meter software bug may transmit erroneous glucose values to healthcare systems, potentially leading to incorrect patient treatment. 2,365 units affected nationwide and internationally.

    Product
    StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0656-2025·2024-12-25

    Surgical Bipolar Pencil Recall: Risk of Tube Breakage During Eye Surgery

    Kirwan Surgical Products is recalling disposable bipolar surgical pencils used in eye surgery because the outer stainless-steel tube may break or detach during use.

    Product
    Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0661-2025·2024-12-25

    Medtronic Becker Neurosurgical Drainage Systems Recalled for Cracked and Leaking Stopcocks

    Medtronic Neurosurgery recalls Becker External Drainage and Monitoring Systems due to reports of cracks and leaks in stopcocks. The recalled systems are used to drain cerebrospinal fluid and monitor pressure in neurosurgery patients.

    Product
    Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 27670 BECKER 27670 STOP BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0662-2025·2024-12-25

    Exacta External Drainage System Stopcocks May Leak or Crack

    Medtronic Neurosurgery is recalling Exacta External Drainage and Monitoring Systems worldwide due to complaints of cracking and leaking stopcocks. These components control cerebrospinal fluid drainage and intracranial pressure monitoring.

    Product
    Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0668-2025·2024-12-25

    FDA Recalls Draeger Atlan A300XL Anesthesia Workstation for Ventilator Failure

    Draeger Medical recalls the Atlan A300XL anesthesia workstation for potential piston ventilator failure that could occur before use or during anesthesia delivery. Twenty-five units were distributed outside the United States.

    Product
    Brand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0660-2025·2024-12-25

    Optikon Bipolar Pencil surgical tool recalled for tube failure risk

    FDA recalls Kirwan Surgical's Optikon Bipolar Pencil surgical instruments due to risk that the outer stainless-steel tube may break or detach during use. The recalled devices were distributed worldwide.

    Product
    Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0667-2025·2024-12-25

    Draeger Atlan A300 anesthesia workstation ventilator failure FDA Class I recall

    Draeger Atlan A300 anesthesia workstations can fail to ventilate properly before or during use. The FDA classified this as Class I due to the critical risk to patient ventilation.

    Product
    Brand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0654-2025·2024-12-25

    Kirwan Surgical Disposable Bipolar Pencils recalled for potential tube failure

    Kirwan Surgical Products is recalling 80,060 Disposable Bipolar Pencils (Model 14-5011) because the outer stainless-steel tube may break or detach during surgical use. The devices were distributed worldwide.

    Product
    Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog Number: 14-5011 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0659-2025·2024-12-25

    Nidek Disposable Bipolar Pencil Surgical Instruments Recalled for Tube Breakage Risk

    Kirwan Surgical Products recalls Nidek Disposable Bipolar Pencil surgical instruments due to risk that the stainless-steel tube may break or detach during procedures.

    Product
    Nidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: 18241-0979. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauteriza
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0655-2025·2024-12-25

    Kirwan Surgical Bipolar Pencil Recalled Due to Potential Tube Breakage

    Kirwan Surgical Products is recalling its Disposable 25-gauge Bipolar Pencil (Model 14-5011L) because the outer stainless-steel tube may break or detach during use. The defect could create a safety hazard during eye surgery and other soft tissue procedures.

    Product
    Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauteri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0658-2025·2024-12-25

    Walcott Bipolar Pencil Surgical Instrument Recalled for Potential Tube Detachment

    Kirwan Surgical Products is recalling Walcott Bipolar Pencil 25 Gauge surgical instruments due to potential breakage or detachment of the stainless-steel tube. The affected pencils are used in eye and soft tissue surgery.

    Product
    Walcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0328-2025·2024-12-04

    Hologic BioZorb Radiographic Marker Recalled Due to Serious Injury Reports

    Hologic has recalled 12,710 BioZorb Markers nationwide after receiving reports of serious complications including infection, device migration, and device erosion. The FDA classified this as a Class I recall.

    Product
    BioZorb Marker. Radiographic soft tissue marker.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0382-2025·2024-11-27

    Baxter Peritoneal Dialysis Transfer Sets Recalled for Chemical Exposure

    Baxter Healthcare Corporation is recalling 1,240 units of MiniCap Extended Life PD Transfer Sets (Part Number T5C4484) due to potential exposure to polychlorinated biphenyls and related compounds when used in peritoneal dialysis treatments.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0377-2025·2024-11-27

    Baxter Peritoneal Dialysis Transfer Set Recalled for PCB Contamination Risk

    Baxter Healthcare is recalling the MiniCap Extended Life PD Transfer Set due to potential exposure to polychlorinated biphenyls (PCBs). Approximately 410,862 units are affected.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide