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

4351–4375 of 13449

  • HighFDA (Devices)·Z-0539-2025·2024-12-04

    Philips Breast MRI System Recalled for Patient Safety Risk

    Philips is recalling 5,231 units of the dS Breast 7ch 1.5T breast MRI system due to a potential safety issue that could harm patients during preparation or scanning.

    Product
    dS Breast 7ch 1.5T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0532-2025·2024-12-04

    Medline Surgical Kits Recalled for Incorrect Needle and Suture Specifications

    Medline Industries is recalling 408 surgical kits from Alabama, Georgia, Massachusetts, New Jersey, and Pennsylvania. Some suture packages within the kits contain incorrect needle types and sizes, and incorrect suture diameters and lengths.

    Product
    (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2025·2024-12-04

    GE SIGNA Architect MRI Systems Recalled for Elevated Acoustic Noise

    GE Medical Systems is recalling certain SIGNA Architect MRI systems because their gradient coils can produce elevated acoustic noise during scanning under specific conditions, potentially risking hearing damage.

    Product
    SIGNA Architect, Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0535-2025·2024-12-04

    VITROS Chemistry CRP Diagnostic Slides May Underreport Elevated Results

    Ortho-Clinical Diagnostics is recalling 7,717 units of VITROS CRP diagnostic slides that may produce falsely low results for high C-reactive protein samples, risking missed diagnosis of infection or inflammation.

    Product
    VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2025·2024-12-04

    Medline Surgical Implant Kits Recalled for Incorrect Suture Specifications

    Medline is recalling 360 surgical implant and thoracotomy kits because some suture packages contain incorrect needle types, sizes, or suture diameters and lengths. The affected kits were distributed to healthcare facilities in five states.

    Product
    (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline Thoracotomy Morristown, REF DYNJ904220F, 1 kit/case, non-sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2025·2024-12-04

    AMS Artificial Urinary Sphincter Balloon Mislabeled With Wrong Component

    Boston Scientific recalls 52 mislabeled AMS Artificial Urinary Sphincter balloons that may contain a Control Pump instead of the labeled Pressure Regulating Balloon component.

    Product
    AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
    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-0561-2025·2024-12-04

    Baxter Peritoneal Dialysis Transfer Set Connector Separation Recall

    Baxter Healthcare is recalling its MiniCap Extended Life PD Transfer Set due to reports of connector separation that could interrupt dialysis treatment. The recall affects 31,248 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
    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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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