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.

Filters

Agency

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

3901–3925 of 27375

  • HighFDA (Devices)·Z-0371-2025·2024-11-20

    Venclose RF Ablation Catheters Recalled for Wiring Defect Causing Excessive Heat

    Bard Peripheral Vascular's Venclose RF ablation catheters may have swapped signal wires causing excessive heating. The defect can lead to temperatures exceeding therapeutic levels, increasing risk of thermal injury.

    Product
    The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2025·2024-11-20

    Halyard Angiography Pack Surgical Instruments Recalled Due to Loose Metal Flakes

    AVID Medical is recalling Halyard angiography pack surgical instruments due to loose metal flakes that could detach and enter a patient's surgical site, potentially causing foreign body reactions.

    Product
    Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalCPSC·25046·2024-11-14

    Medical King adult bed rails recalled for entrapment and asphyxia hazard

    Medical King bed rails (about 222,000 units) are being recalled because they can trap users between the rail and mattress, posing asphyxiation risk. One death has been reported.

    Product
    Medical King Bed Assist Rail adult bed rails
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0227-2025·2024-11-13

    Elekta Disposable Biopsy Needles Recalled for Internal Debris Contamination

    Elekta recalls disposable biopsy needles for the Leksell Stereotactic System due to microscopic stainless steel debris found inside the needles. 111 kits (666 needles) distributed across multiple U.S. states are affected.

    Product
    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465,
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0286-2025·2024-11-13

    epoc BGEM BUN Test Cards recalled for sodium measurement bias

    Siemens recalled epoc BGEM BUN Test Cards for a negative sodium bias occurring approximately 2 months before expiration, with maximum observed bias of -10 mmol/L. No adverse events reported.

    Product
    epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0318-2025·2024-11-13

    GE Healthcare Centricity Viewer Security Vulnerability Could Allow Unauthorized Access

    GE Healthcare's Centricity Universal Viewer Zero Footprint medical imaging software contains a security vulnerability that could allow unauthorized access and patient data manipulation. Approximately 120 units are affected worldwide.

    Product
    GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2089507-093, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02268286, 10510-3-Centricity Universal Viewer Zero Footprint / ZFP-02030900, 1495-1-Centric
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0323-2025·2024-11-13

    Electrocardiograph DICOM Files Risk Patient Data Mismatch Due to Duplicate Identifiers

    Certain Hillrom Welch Allyn Vision Express Holter Analysis Systems may assign duplicate identifiers to cardiac exam files, risking mismatch between patient identities and their physiological data.

    Product
    Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0319-2025·2024-11-13

    Coated VICRYL Surgical Sutures Recalled for Needle Pull-Off and Degradation

    Ethicon is recalling Coated VICRYL surgical sutures due to needle pull-off and visual degradation. Lot QP2AJM, consisting of 31,032 units, was distributed to China.

    Product
    Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0326-2025·2024-11-13

    Smith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring

    Smith & Nephew is recalling 21 units of a Tandem Bipolar Hip System component due to an oversized retainer ring in the femoral head assembly. The affected devices were distributed internationally to nine countries.

    Product
    Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0309-2025·2024-11-13

    DeRoyal Surgical Procedure Pack Smoke Evacuation Pencil Recalled

    DeRoyal is recalling surgical procedure pack products containing a Stryker SafeAir Smoke Evacuation Pencil that may activate without manual input or remain active after buttons are released. The malfunction poses a risk of injury during surgical procedures.

    Product
    DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0325-2025·2024-11-13

    Cardiac stress testing system may assign duplicate exam identifiers to patients

    Hillrom Welch Allyn XScribe cardiac stress testing systems may assign duplicate exam identifiers, potentially causing patient data mismatches in medical record systems.

    Product
    Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0306-2025·2024-11-13

    DeRoyal C-Section Tracepack Recall Due to Stryker Smoke Evacuation Pencil Defect

    DeRoyal is recalling C-Section Tracepacks containing a Stryker SafeAir Smoke Evacuation Pencil that may activate without manual input or remain active after buttons are released.

    Product
    DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0313-2025·2024-11-13

    Beckman Coulter Access Cortisol Assay Recalled for Calibration Error

    Beckman Coulter is recalling 149 units of the Access Cortisol assay due to an incorrect calibration curve parameter that may cause test delays and potential injuries.

    Product
    The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0289-2025·2024-11-13

    Medtronic DLP Aortic Root Cannula Recalled for Potential Sterility Breach

    Medtronic is recalling 420 units of DLP Aortic Root Cannulas due to a potential sterility breach caused by a misaligned seal.

    Product
    Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0322-2025·2024-11-13

    Electrocardiograph System May Assign Duplicate Identifiers to Patient Exams

    The Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System may assign duplicate file identifiers that could cause patient data to be mismatched in DICOM archive systems.

    Product
    Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0307-2025·2024-11-13

    DeRoyal Children's Surgical Pack Recalled for Smoke Pencil Malfunction

    DeRoyal is recalling certain lots of children's surgical procedure packs due to reports that the included Stryker smoke evacuation pencil may activate without manual input or remain active after buttons are released.

    Product
    DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0287-2025·2024-11-13

    Surgical neurological sponges recalled for detaching X-ray markers

    American Surgical Company is recalling 390 units of Americot 20-01S neurological sponges used in surgery. The X-ray detectable barium strip may detach, potentially delaying the surgical process.

    Product
    Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0308-2025·2024-11-13

    DeRoyal Children's Orthopedic Tracepack Smoke Evacuation Pencil Malfunction Recall

    DeRoyal is recalling 384 units of Children's Orthopedic TracePacks containing a Stryker smoke evacuation pencil that may activate unexpectedly or fail to deactivate, posing a burn risk during surgery.

    Product
    DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0320-2025·2024-11-13

    Hillrom HScribe Holter System cardiac monitoring devices duplicate identifier risk

    Hillrom HScribe Holter System monitoring devices may assign duplicate file identifiers, risking patient identification mismatches in medical systems that use the identifier to match patient data to cardiac recordings.

    Product
    Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0324-2025·2024-11-13

    Hillrom Diagnostic Cardiology Suite Software Duplicate UID Assignment Recall

    Hillrom diagnostic cardiology spirometer software may incorrectly assign duplicate identifiers to exam files, risking patient data mismatches. 1,369 units affected worldwide.

    Product
    Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0285-2025·2024-11-13

    Endoscopic Vessel Harvesting System Recalled for Assembly Defect

    Zimmer recalls the Venapax XL endoscopic vessel harvesting system due to assembly defects that may cause endoscope interference during surgery. A Gen 5 tail piece was incorrectly assembled to Gen 4 devices, affecting 432 units nationwide.

    Product
    Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. Item Number: VPX4000 (7273)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0321-2025·2024-11-13

    Cardiac stress testing system recalled due to duplicate patient identifiers

    The Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System may assign duplicate unique identifiers to exam files, potentially causing patient identification mismatches with their cardiac test data.

    Product
    Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0222-2025·2024-11-06

    Ambulatory Infusion System Batteries May Short Circuit and Overheat

    CADD-Solis battery packs used in ambulatory infusion systems may develop internal short circuits causing battery case melting and charging circuit failure. The FDA Class I recall affects 138,039 units worldwide.

    Product
    CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-0200-03, 21-2101-0200-06, 21-2101-0200-07, 21-2101-0200-12, 21-2101-0200-14, 21-210
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0141-2025·2024-11-06

    GE Healthcare Infant Incubator Recall: Airborne Formaldehyde Off-Gassing

    GE Healthcare Giraffe Incubator Carestation CS1 units may release airborne formaldehyde residue during initial use. Manufacturer notified customers in June 2023 to run incubators for one week to off-gas any residual formaldehyde, which can cause eye irritation.

    Product
    GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 208
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0208-2025·2024-11-06

    Phasitron5 breathing circuits recalled for nickel-coated spring discoloration

    Percussionaire Corporation is recalling Phasitron5 breathing circuits (P5-10, P5-HC, P5-UC-10) due to discolored fluid caused by an unintended nickel coating on the spring component reacting with medicated mist. 43,830 devices have been distributed across the U.S.

    Product
    Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
    Category
    Medical Device
    Distribution
    40 states