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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4376–4400 of 13449

  • HighFDA (Devices)·Z-0548-2025·2024-12-04

    Philips ST SENSE Breast Imaging Coil Recalled for Patient Safety Risk

    Philips is recalling 5,231 units of the ST SENSE Breast Dx Coil nationwide due to a potential safety issue that may harm patients during breast imaging scans. No injuries have been reported.

    Product
    ST SENSE Breast Dx Coil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0564-2025·2024-12-04

    Baxter Peritoneal Dialysis Transfer Set Recalled for Connector Separation

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets due to an increase in complaints of female connector separation from the transfer set body. Peritoneal dialysis patients should contact their healthcare provider.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0530-2025·2024-12-04

    AMS Artificial Urinary Sphincter Control Pump: Mislabeled Packaging Recall

    Boston Scientific recalled 16 units of AMS Artificial Urinary Sphincter Control Pumps due to mislabeled packaging where devices labeled as Pressure Regulating Balloons actually contained Control Pumps.

    Product
    AMS Artificial Urinary Sphincter Control Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0541-2025·2024-12-04

    Mammotrak Diagnostic Coil 1.5T Recalled Due to Patient Safety Concern

    Philips is recalling 5,231 Mammotrak Diagnostic Coil 1.5T units nationwide because of a potential patient safety issue during MRI scans. The FDA has classified this as a Class II recall.

    Product
    Mammotrak Diagnostic Coil 1.5T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0502-2025·2024-12-04

    Defibtech Defibrillation Pads Mislabeled, Creating Risk of Expired Pads in Use

    Defibtech DDP-100 defibrillation pads distributed in Ireland had authorized labels replaced with unauthorized ones, making expired pads appear fresh. Dried hydrogel on expired pads may fail to deliver adequate energy for cardiac resuscitation.

    Product
    Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on victims of sudden cardiac arrest (SCA)
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-0527-2025·2024-12-04

    Smiths Medical Tracheal Tube Introducer Recall Due to Inadequate Disinfection

    Smiths Medical is recalling reusable tracheal tube introducers due to potential fluid ingress during reprocessing and concerns about the adequacy of recommended disinfectants.

    Product
    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
    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-0547-2025·2024-12-04

    Philips ST SENSE Breast Coil Recalled for Potential Patient Safety Risk

    Philips is recalling 5,231 ST SENSE Breast Coils nationwide due to a potential safety issue that could harm patients during MRI scanning. Affected units are identified by specific serial numbers.

    Product
    ST SENSE Breast Coil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0505-2025·2024-12-04

    Defibtech Pediatric Defibrillation Pads: Mislabeling and Hydrogel Drying Risk

    Defibtech DDP-2002 pediatric defibrillation pads distributed in Ireland may be mislabeled with unauthorized labels, potentially making expired pads appear current. Hydrogel drying could impair electrical connection and reduce energy delivery during treatment.

    Product
    Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, Lifeline ECG, Lifeline View (DDU-2XXX Series -Indicated for use on victims of sudden cardiac arrest (SCA.)
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-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-0559-2025·2024-12-04

    Baxter MiniCap Peritoneal Dialysis Transfer Set Connector Separation Recall

    Baxter is recalling MiniCap Extended Life PD Transfer Sets (Part Number 5C4482) due to reports of the female connector separating from the main body. Approximately 409,464 units are affected worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-0513-2025·2024-12-04

    MEDLINE Epidural and Spinal Procedure Kits: Connector May Prevent Catheter Insertion

    MEDLINE is recalling 3,744 epidural and spinal procedure kits due to a connector defect that may prevent proper catheter insertion. Affected kits were distributed nationwide and internationally.

    Product
    MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G NYL W/TUOHY, REF PAIN9023; 4) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281 5) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN9024
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0510-2025·2024-12-04

    Medline Epidural Catheter Kits Recalled Due to Connector Position Defect

    Medline is recalling over 5,900 epidural catheter kits because the connectors may not open fully, preventing proper catheter insertion. The recall affects units distributed nationwide and internationally.

    Product
    MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0504-2025·2024-12-04

    Defibtech Adult Defibrillation Pads Recalled for Labeling Error Risk

    Defibtech is recalling 22,294 DDP-2001 Adult Defibrillation Pads distributed in Ireland. Some pads had unauthorized labels applied, which could allow expired pads to appear current, and dried hydrogel may reduce electrical delivery during use.

    Product
    Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View (DDU-2XXX Series). -Indicated for use on victims of sudden cardiac arrest (SCA.)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0544-2025·2024-12-04

    Philips Mammotrak Interventional Coil MRI Device Recalled for Patient Safety

    Philips recalls 5,231 Mammotrak Interventional Coil 3.0T MRI devices nationwide due to a potential safety issue that could harm patients during scan preparation or imaging.

    Product
    Mammotrak Interventional Coil 3.0T
    Category
    Medical Device
    Distribution
    Distributed nationwide