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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5201–5225 of 39968

  • 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-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-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-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-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-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-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-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-0560-2025·2024-12-04

    Baxter MiniCap Peritoneal Dialysis Transfer Set Connector Separation Recall

    Baxter is recalling 22,392 units of MiniCap Extended Life PD Transfer Sets (Part Number 5C4482EJ) due to reports of female connector separation. Affected units were distributed worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0558-2025·2024-12-04

    Medline Endo Kit Recall: Missing Lot and Expiration Date Labels

    Medline is recalling Endo Kit models containing Olympus components with missing sterile and manufacturing lot numbers and expiration dates on packaging. Without this labeling, medical facilities cannot verify product expiration or track inventory.

    Product
    ENDO KIT, Medline Kit SKU DYKE1577A, Component Number 57469, 10 per case; Medline Convenience Kits containing Single Use Biopsy Valve MAJ-1555
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0551-2025·2024-12-04

    Abbott Merlin@home Cardiac Monitoring Transmitters Fail to Update After Power Loss

    Abbott is recalling 130 Merlin@home cardiac transmitters that cannot update software after power interruption during firmware download. Affected devices remain on outdated firmware with no ability to receive future updates.

    Product
    Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0554-2025·2024-12-04

    Shimadzu Autosampler Devices Subject to Water Damage Affecting Main Board

    Water condensation may accumulate under the autosampler's thermal insulation and damage the main board, causing communication errors and delays in laboratory testing. Two Shimadzu models are affected: SIL-40C XR CL and SIL-40C X3 CL.

    Product
    Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0520-2025·2024-12-04

    GE SIGNA and DISCOVERY PET/MR Scanners Recalled for Elevated Acoustic Noise

    GE Medical Systems is recalling SIGNA PET/MR and DISCOVERY PET/MR imaging systems because gradient coils can produce elevated acoustic noise during scanning under specific conditions.

    Product
    Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0550-2025·2024-12-04

    GE Proteus XR/A radiographic system Wall Stand cable maintenance recall

    GE Healthcare is recalling certain Proteus XR/A radiographic systems because steel cables in the Wall Stand component have not been replaced at manufacturer-specified maintenance intervals.

    Product
    GE Proteus XR/A radiographic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0523-2025·2024-12-04

    Z-800WF Infusion Pumps Recalled for Software Incompatibility Issue

    Zyno Medical LLC is recalling Z-800WF infusion pumps due to incompatibility between WiFi software and the pump's operating software. The affected units were distributed in eight U.S. states.

    Product
    Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision physician or other certi
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0552-2025·2024-12-04

    Heart Device Transmitter Fails to Update Software After Power Interruption

    Abbott Medical's Merlin@home transmitter cannot upgrade to current software after power interruptions during prior downloads. This affects remote heart device monitoring systems.

    Product
    Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0557-2025·2024-12-04

    Tempus LS-Manual Defibrillator Recalled for Incorrect Servicing Labels

    Remote Diagnostic Technologies Ltd. is recalling Tempus LS-Manual Defibrillator Model 00-3020 units distributed in eight U.S. states. The devices were labeled incorrectly during servicing with wrong product name and CAT number.

    Product
    Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
    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-0375-2025·2024-11-27

    Baxter peritoneal dialysis transfer set recalled for PCB exposure risk

    Baxter MiniCap Extended Life PD Transfer Sets (Part 5C4482S) are being recalled due to potential exposure to polychlorinated biphenyls (PCBs). The FDA Class I recall affects 151,020 units distributed worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0378-2025·2024-11-27

    Baxter MiniCap Peritoneal Dialysis Transfer Set recalled for potential PCB exposure

    Baxter Healthcare is recalling 58,680 units of its MiniCap Extended Life PD Transfer Set due to potential exposure to polychlorinated biphenyls (PCBs). Users should stop using affected units and consult 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
    Distributed nationwide
  • SevereFDA (Devices)·Z-0482-2025·2024-11-27

    Medical Device Recall: Counterfeit Batteries in Plum Infusion Systems

    Counterfeit CSB batteries are being used in Plum Infusion Systems. These unauthorized batteries fail to hold their charge and have not been tested for use with the pumps.

    Product
    Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0379-2025·2024-11-27

    Baxter MiniCap Dialysis Transfer Sets Recalled for PCB Exposure Risk

    Baxter is recalling MiniCap Extended Life PD Transfer Sets used in peritoneal dialysis due to potential exposure to polychlorinated biphenyls (PCBs). About 62,394 units distributed worldwide may be affected.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0373-2025·2024-11-27

    Peritoneal Dialysis Transfer Set Recalled for PCB Contamination Risk

    Baxter Healthcare recalls peritoneal dialysis transfer sets (Part Number 5C4482) due to potential contamination with polychlorinated biphenyls (PCBs). The recall affects 2.7 million units distributed worldwide.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; 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