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

Category

Minimum severity

Clear filters

4426–4450 of 13512

  • HighFDA (Devices)·Z-0569-2025·2024-12-04

    Baxter MiniCap Extended Life PD Transfer Set—Connector Separation Recall

    Baxter Healthcare is recalling the MiniCap Extended Life PD Transfer Set due to reports of the female connector separating from the transfer set body. The defect may compromise dialysis treatment safety.

    Product
    Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0522-2025·2024-12-04

    HPV-16 Diagnostic Probe Recalled for Suboptimal DNA Hybridization

    Kreatech PapV-16 HPV-16 diagnostic probes are recalled for suboptimal DNA hybridization due to oversized DNA fragments. This may cause false positives or false negatives if proper laboratory controls are not used.

    Product
    Kreatech PapV-16, Flu labeled ISH probe, to detect presence of HPV-16 DNA inserts in human tissue, Model Number 40V016V495
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0565-2025·2024-12-04

    Baxter Peritoneal Dialysis Transfer Set: Female Connector Separation Risk

    Baxter Healthcare recalls 8,394 MiniCap Extended Life PD Transfer Sets due to complaints of female connector separation from the transfer set body. This mechanical failure could interrupt dialysis treatment.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis
    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-0537-2025·2024-12-04

    Philips dS Breast 16ch 1.5T MRI Recalled for Patient Safety Risk

    Philips North America is recalling approximately 5,231 dS Breast 16ch 1.5T MRI systems nationwide due to a potential safety issue that could harm patients during scan preparation or procedures.

    Product
    dS Breast 16ch 1.5T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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-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
  • HighFDA (Devices)·Z-0508-2025·2024-12-04

    Medline Nexus Catheter Connectors May Fail to Open Properly

    Medline recalls 1,975 NEXUS catheter connectors that may not fully open, preventing proper catheter insertion. Affected units were distributed nationwide and internationally.

    Product
    MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector
    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-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-0553-2025·2024-12-04

    Shimadzu Autosampler Water Intrusion May Cause Electrical Short Circuit

    Shimadzu laboratory autosamplers are being recalled due to water intrusion from a dehumidifier that can cause electrical short circuits. Affected units are distributed worldwide, including across the United States.

    Product
    Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
    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-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-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-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-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-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-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-0514-2025·2024-12-04

    MEDLINE Neuraxial Kit Connectors May Prevent Catheter Insertion

    MEDLINE has recalled 360 units of its Neuraxial Kit (Lot 23KLA330) because connectors may not fully open, potentially preventing catheters from being inserted as intended. Healthcare facilities should discontinue use and contact MEDLINE.

    Product
    MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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