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

5126–5150 of 39987

  • HighFDA (Devices)·Z-0516-2025·2024-12-04

    RENASYS EDGE Pump Recall Due to Battery Charging Failure Risk

    Smith & Nephew recalls 1,589 RENASYS EDGE wound therapy pumps due to battery charging failure if not properly maintained. Affected patients may experience treatment interruption.

    Product
    RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0507-2025·2024-12-04

    V.A.C. Ulta Therapy Units Recalled Due to Occlusion Sensor Failures

    KCI USA is recalling 83,721 V.A.C. Ulta Negative Pressure Wound Therapy Units due to broken occlusion sensors that may prevent the device from initiating therapy. Affected units are distributed worldwide.

    Product
    V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0563-2025·2024-12-04

    Baxter Peritoneal Dialysis Transfer Set Connector Separation Recall

    Baxter is recalling 83,448 units of MiniCap Extended Life PD Transfer Sets due to reports of female connector separation from the device body.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0568-2025·2024-12-04

    Baxter Dialysis Transfer Set Recalled for Connector Separation

    Baxter Healthcare is recalling its MiniCap Extended Life PD Transfer Set (Part Number T5C4325K) due to increased complaints about the female connector separating from the main body of the device.

    Product
    Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0519-2025·2024-12-04

    GE SIGNA Architect AIR MRI Systems Recalled for Elevated Acoustic Noise

    GE Medical Systems is recalling three SIGNA Architect AIR MRI systems due to gradient coils that can produce elevated acoustic noise during scanning. The units were distributed to the US and 12 countries worldwide.

    Product
    SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0580-2025·2024-12-04

    MICRO-X Rover Mobile X-ray System environmental operating requirements

    Micro-X Ltd. is recalling 6 units of the MICRO-X Rover Mobile X-ray System due to environmental operating risks. The system requires strict temperature, humidity, and altitude controls to prevent capacitor malfunction, overheating, and unintended start-up.

    Product
    MICRO-X Rover Mobile X-ray System, # MXU-RV35
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0528-2025·2024-12-04

    Smiths Medical Tracheal Tube Exchange Guide Recalled for Inadequate Disinfection Risk

    Smiths Medical recalled its PORTEX Tracheal Tube Exchange Guide due to potential fluid ingress during reprocessing that may compromise disinfection standards and pose a contamination risk.

    Product
    smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0567-2025·2024-12-04

    Baxter MiniCap PD Transfer Set Recalled for Female Connector Separation

    Baxter Healthcare is recalling 1,496 units of MiniCap Extended Life PD Transfer Sets due to reports of female connector separation. The affected lots should not be used until assessed by Baxter.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0512-2025·2024-12-04

    MEDLINE Procedure Kits: Connectors May Prevent Intended Catheter Insertion

    MEDLINE procedure kits are being recalled because connectors may not allow proper catheter insertion if not fully opened. The recall affects 3006 units distributed in the US and internationally.

    Product
    MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COMPATIBLE, REF PAIN1470A; 3) EPIDURAL CATHETERIZATION KIT, REF PAIN1644
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0566-2025·2024-12-04

    Baxter MiniCap Extended Life PD Transfer Set Connector Separation Complaints

    Baxter Healthcare is recalling the MiniCap Extended Life peritoneal dialysis transfer set due to complaints about female connector separation from the main body. The Class II recall affects 3,204 units distributed worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0509-2025·2024-12-04

    MEDLINE Epidural and Spinal Anesthesia Procedure Kits: Connector Insertion Issue

    Multiple MEDLINE procedure kits used for epidural and spinal anesthesia have connectors that may not open fully, preventing proper catheter insertion during medical procedures.

    Product
    MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C; 3) FEMORAL BLOCK TRAY, REF DYNJRA1739A; 4) FEMORAL BLOCK TRAY, REF DYNJRA1739B; 5) 18G CPNB 20G STYLETED CATHETER, REF DYNJRA1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0526-2025·2024-12-04

    Karl Storz surgical instruments recalled for sterility barrier defect

    Karl Storz Endoscopy has recalled 105 surgical instruments with holes in their sterility barriers. The defect may compromise product sterility; affected devices were distributed nationwide and internationally.

    Product
    4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x 5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x 6.5 x 120 mm REF 28205HES, Aggressi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0536-2025·2024-12-04

    Philips Achieva TX Interventional Coil 3.0T Recalled for Patient Safety Risk

    Philips recalls the Achieva TX Interventional Coil 3.0T (5,231 units) for a potential safety issue that may harm patients during MRI scan preparation or procedures.

    Product
    Achieva TX Interventional Coil 3.0T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0549-2025·2024-12-04

    Offset Cup Impactor Surgical Instruments Recalled for Weld Fracture

    INCIPIO DEVICES is recalling 100 units of Offset Cup Impactor surgical instruments (Lot 24A0087) because the TIG weld does not meet specifications and has fractured. These instruments are used in hip surgery to position acetabular cup implants.

    Product
    Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0562-2025·2024-12-04

    Baxter MiniCap Peritoneal Dialysis Sets Recalled for Connector Separation

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets due to increasing reports of the female connector separating from the main body. The defect affects 62,718 units distributed worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0534-2025·2024-12-04

    Medline Shoulder Repair Pack-LF Recalled for Incorrect Surgical Components

    Medline is recalling Shoulder Repair Pack-LF surgical kits (lot 24ABO552) due to incorrect needle type/size and suture diameter/length in some packages. No patient injuries have been reported.

    Product
    Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2025·2024-12-04

    Pediatric defibrillation pads recalled due to labeling and hydrogel degradation

    Defibtech DDP-200P pediatric defibrillation pads distributed in Ireland are recalled due to unauthorized labeling that could make expired pads appear current, and hydrogel drying that may reduce electrical effectiveness.

    Product
    Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto (DDU-l XX Series)-Indicated for use on victims of sudden cardiac arrest (SCA.)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0571-2025·2024-12-04

    Essenz HLM Heart-Lung Machines May Fail Due to Software Defect

    The recalled Essenz HLM heart-lung machines (38 units) may experience GUI display failures and sensor deactivation. This can lead to hypoxia and hypoperfusion.

    Product
    Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0570-2025·2024-12-04

    Arial Server Software Fails to Notify Users of Emergency Calls

    Securitas Healthcare's Arial Server Software versions 11.1.4 through 11.1.6 may fail to notify users when emergency calls are initiated through the Arial Nurse Call System, posing a patient safety risk.

    Product
    Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0529-2025·2024-12-04

    Tracheal Tube Exchange Guide Recalled for Inadequate Disinfection Risk

    Smiths Medical is recalling PORTEX Tracheal Tube Exchange Guides due to potential fluid ingress during reprocessing and inadequate disinfection per applicable standards.

    Product
    smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0572-2025·2024-12-04

    TriALTIS Torque Limiter Ratchet Recalled for Excessive Torque Output

    Gauthier Biomedical is recalling the TriALTIS TORQUE LIMITER due to an out-of-specification component that may cause the device to produce higher torque output than intended. The recall affects 160 units.

    Product
    TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0543-2025·2024-12-04

    Philips Mammotrak Diagnostic Coil 3.0T Recall Due to Patient Safety Risk

    Philips is recalling 5,231 Mammotrak Diagnostic Coil 3.0T units due to a potential safety issue that could harm patients during MRI scan preparation or scanning.

    Product
    Mammotrak Diagnostic Coil 3.0T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0538-2025·2024-12-04

    Philips dS Breast MRI System Recalled for Patient Safety Hazard

    Philips dS Breast 16ch 3.0T MRI systems are being recalled due to a potential safety issue that could harm patients during medical scans. The FDA-mandated Class II recall affects 5,231 units distributed nationwide.

    Product
    dS Breast 16ch 3.0T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0521-2025·2024-12-04

    Surgical forceps and scissors handles recalled due to pin detachment

    MicroSurgical Technology is recalling MST Duet Reusable Handles for surgical forceps and scissors due to pin detachment risk. Six units distributed in the US; 18 internationally.

    Product
    Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product Description: A MST Single Use Forceps or Scissors System consists of a reusable han
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0542-2025·2024-12-04

    Mammotrak Interventional Coil 1.5T recalled for patient safety risk

    Philips is recalling 5,231 units of the Mammotrak Interventional Coil 1.5T nationwide due to a potential safety issue that may harm patients during MRI preparation or scanning.

    Product
    Mammotrak Interventional Coil 1.5T
    Category
    Medical Device
    Distribution
    Distributed nationwide