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 27375

  • HighFDA (Devices)·Z-0481-2025·2024-11-27

    CAIRE FreeStyle Comfort portable oxygen concentrator battery recharge failure

    Caire Inc. is recalling 26 CAIRE FreeStyle Comfort portable oxygen concentrators due to potential battery recharge failure. Affected units identified by serial number may not charge properly.

    Product
    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
    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
  • HighFDA (Devices)·Z-0493-2025·2024-11-27

    Abbott Navitor Transcatheter Aortic Heart Valve Recalled for Manufacturing Defect

    Three Abbott Navitor 29mm transcatheter aortic heart valves were recalled due to a manufacturing error that allowed valves with leaflet deflection outside specifications to be distributed. The defect could affect valve durability or cause valve failure.

    Product
    Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • 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-0497-2025·2024-11-27

    Philips Vue PACS Diagnostic Viewer Software Recall for Calculation Errors

    Philips is recalling Vue PACS Diagnostic Viewer software versions 12.1.5 to 12.2.8.454 because a defect may cause incorrect ischemic map calculations, potentially leading to misdiagnosis.

    Product
    Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) solutions for hospital and related institutions/sites.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2025·2024-11-27

    Hip Prosthesis Mislabeled with Wrong Size; Risk of Joint Instability

    Novosource is recalling NovoHip Total Hip System units (lot CER0023) packaged in boxes labeled 32 long but containing 28 long components. If implanted, the wrong size may cause joint instability.

    Product
    NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral stem, femoral head, acetabular poly liner, and acetabular metal (or shel
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0486-2025·2024-11-27

    Acrobat-i Vacuum Stabilizer System Recalled for Sterile Barrier Compromise

    Maquet Cardiovascular is recalling approximately 33,823 units of the Acrobat-i Vacuum Stabilizer System due to manufacturing deviations that compromised the sterile barrier. Sterility cannot be assured for the 2-year shelf life.

    Product
    Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
    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-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-0475-2025·2024-11-27

    Posi-Stop 25-Gauge Injection Needles Recalled for Manufacturing Debris Blockage

    Hobbs Medical is recalling Posi-Stop 25-Gauge injection needles because some units contain manufacturing debris that blocks the needle's inner diameter, preventing injection solutions from flowing properly.

    Product
    Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0492-2025·2024-11-27

    Abbott Navitor Transcatheter Aortic Heart Valve Recalled for Manufacturing Defect

    Abbott Medical is recalling the Navitor 29mm transcatheter aortic heart valve due to a manufacturing error affecting leaflet specifications. The defect could potentially impact long-term valve durability or cause valve failure.

    Product
    Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0480-2025·2024-11-27

    CAIRE FreeStyle Comfort Portable Oxygen Concentrator Battery Recharge Failure

    Six CAIRE FreeStyle Comfort oxygen concentrators may fail to recharge their batteries, potentially affecting portable use of these medical devices. Caire, Inc. is recalling affected units worldwide.

    Product
    CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0374-2025·2024-11-27

    Baxter MiniCap Peritoneal Dialysis Transfer Set Recalled for Chemical Exposure Risk

    Baxter is recalling MiniCap Extended Life PD Transfer Sets due to potential exposure to polychlorinated biphenyls found in similar devices.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0477-2025·2024-11-27

    JuggerLoc/ToggleLoc 2.9mm Drill Guide Warping in Packaging

    Biomet's JuggerLoc/ToggleLoc 2.9mm Drill Guide may warp when removed from packaging, potentially extending surgical time or causing tissue damage requiring intervention.

    Product
    JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0496-2025·2024-11-27

    Siemens Atellica CH Cuvette Segment manufacturing defect may impact lab test accuracy

    Manufacturing defects in Siemens Atellica CH Cuvette Segments may cause inaccurate laboratory test results for seven analytes across 9,729 units.

    Product
    Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step. Siemens Material Number(SMN): 11099326 All lots starting with N15 or 15 are expected to have the defect.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0376-2025·2024-11-27

    Baxter MiniCap PD Transfer Set Recalled for Potential PCB Exposure

    Baxter is recalling MiniCap Extended Life PD Transfer Sets due to potential exposure to non-dioxin-like polychlorinated biphenyls.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0470-2025·2024-11-27

    Posi-Stop Injection Needle Recall Due to Manufacturing Debris

    Hobbs Medical is recalling Posi-Stop Injection Needles (23 Gauge, Catalog 4706) due to manufacturing debris in the inner sheath that can block the needle and prevent injection solution flow.

    Product
    Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0380-2025·2024-11-27

    Baxter MiniCap Peritoneal Dialysis Transfer Set Recalled for Chemical Exposure Risk

    Baxter is recalling MiniCap Extended Life PD Transfer Sets due to potential exposure to non-dioxin-like polychlorinated biphenyls.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0381-2025·2024-11-27

    Baxter MiniCap PD Transfer Set Recalled for Potential Chemical Exposure Risk

    Baxter is recalling MiniCap Extended Life PD Transfer Sets due to potential exposure to polychlorinated biphenyls.

    Product
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0506-2025·2024-11-27

    Z-800 Infusion System Recalled for Battery Depletion Risk

    Zyno Medical is recalling 34,994 units of the Z-800 Infusion System due to battery depletion risk from self-discharge and parasitic leakage current. The battery may not retain charge despite continuous AC power, potentially affecting device operation.

    Product
    Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, 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 of a physician or other certifie
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0485-2025·2024-11-27

    Acrobat SUV Vacuum Stabilizer System Sterile Barrier Compromise Recall

    Maquet Cardiovascular is recalling the Acrobat SUV Vacuum Stabilizer System (Model C-OM-9000Z) due to manufacturing deviations that compromise the sterile barrier. Sterility cannot be assured during the 2-year shelf life, affecting approximately 10,778 units.

    Product
    Acrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000Z
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0488-2025·2024-11-27

    EnChroma Safety Glasses recalled for defective impact protection

    EnChroma Inc recalls 53 units of safety glasses with Rx indoor lenses that fail impact safety standards, posing a risk of eye injury. Affected models include Martinez Cx1 Indoor Rx, Summit Indoor Rx, and Martinez Black Cx Rx.

    Product
    EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoor Rx, Cx.PC.IN.SUM.BK.Rx; Martinez Black Cx Rx, Cx-3.PC.PT.MTZ.BK.Rx
    Category
    Medical Device
    Distribution
    Distributed nationwide