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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3726–3750 of 27346

  • 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-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-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-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-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-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-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-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-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-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
  • 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-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-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-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
  • 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
  • HighFDA (Devices)·Z-0468-2025·2024-11-27

    Posi-Stop Injection Needles Recalled for Manufacturing Debris Blocking Flow

    Hobbs Medical is recalling Posi-Stop Injection Needles because manufacturing debris blocks the needle, preventing injection solutions from flowing properly. The 70 affected units were distributed to healthcare facilities in multiple U.S. states and Canada.

    Product
    Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0491-2025·2024-11-27

    Abbott Navitor Titan Heart Valve Recall: Manufacturing Defect

    Abbott Medical is recalling 10 units of the Abbott Navitor Titan transcatheter aortic heart valve due to a manufacturing error causing valve leaflets to fall outside specification. The defect could affect valve durability and cause valve failure.

    Product
    Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0479-2025·2024-11-27

    CAIRE FreeStyle Comfort Portable Oxygen Concentrator Battery Charging Failure

    CAIRE FreeStyle Comfort portable oxygen concentrators may fail to recharge their batteries, potentially leaving patients without access to supplemental oxygen. Twenty-three units have been recalled.

    Product
    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2025·2024-11-27

    Medical Device Homocysteine Test Assay Recalled for Calibration Defects

    Roche's cobas HCYS homocysteine test assay is recalled due to calibration defects that can produce inaccurate results. The assay can yield false positive or negative values.

    Product
    cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0478-2025·2024-11-27

    CAIRE FreeStyle Comfort Oxygen Concentrators Recalled for Battery Charging Failure

    Caire recalls 739 FreeStyle Comfort portable oxygen concentrators that may fail to recharge their batteries. The devices were distributed in the US, Puerto Rico, Israel, and Peru.

    Product
    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0499-2025·2024-11-27

    Cook Incorporated Recalls Approach CTO Micro Wire Guide for Incorrect Expiration Dates

    Cook Incorporated is recalling Approach CTO Micro Wire Guide devices due to incorrect expiration dates printed on product labels. Contact the manufacturer for corrected expiration information.

    Product
    Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
    Category
    Medical Device
    Distribution
    0 states