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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4526–4550 of 13543

  • SevereFDA (Devices)·Z-0302-2025·2024-11-20

    Boston Scientific Cryoablation Balloon Catheters Recalled for Fistula Risk

    Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation balloon catheters due to atrio-esophageal fistula risk. Affected devices were distributed worldwide.

    Product
    Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0301-2025·2024-11-20

    Boston Scientific Cryoablation Balloon Catheters Instruction Update for Fistula Risk

    Boston Scientific is updating safety instructions for POLARx cryoablation balloon catheters due to atrio-esophageal fistula risk. The update affects approximately 2,751 units distributed worldwide.

    Product
    Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0293-2025·2024-11-20

    Trilogy EV300 ventilator: potential flow sensor malfunction from aerosol accumulation

    Philips Respironics is recalling 34,146 Trilogy EV300 ventilators due to potential aerosol accumulation on the internal flow sensor, which could cause inaccurate ventilation measurements.

    Product
    Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR2200X15B, TR2200X15B, EE2200X15B. Intended for invasive and non-invasive venti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0297-2025·2024-11-20

    Boston Scientific POLARx Cryoablation Catheters Instructions Updated for Fistula Risk

    Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation catheters to address atrio-esophageal fistula risk, a potentially serious complication from ablation procedures. FDA Class I recall affecting 4422 units worldwide.

    Product
    Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0296-2025·2024-11-20

    Philips LifeVent EVO2 ventilators recalled for potential sensor accuracy failure

    Philips Respironics is recalling LifeVent EVO2 ventilators due to potential aerosol deposit accumulation on the internal flow sensor that could cause inaccurate measurements during ventilation.

    Product
    LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0430-2025·2024-11-20

    Halyard SAMMC ANGIOGRAPHY Medical Kits Recalled for Loose Metal Flakes

    AVID Medical recalls Halyard SAMMC ANGIOGRAPHY medical convenience kits due to loose metal flakes on sponge forceps and towel clamps. Metal flakes may enter surgical sites, potentially causing local reactions or foreign body complications.

    Product
    Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0346-2025·2024-11-20

    Cook Approach CTO Micro Wire Guide recalled for incorrect expiration date labels

    Cook Incorporated is recalling Approach CTO Micro Wire Guide devices due to incorrect expiration dates on affected lot labels. The recall affects 2,005 units in the US and 1,145 units overseas.

    Product
    Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0360-2025·2024-11-20

    Urine kit specimen containers recalled for non-sterile condition

    Medline urine kit specimen containers labeled as sterile are actually non-sterile. This risks sample contamination, infection, and unnecessary treatment.

    Product
    URINE KIT, SKU DYKM1845; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0414-2025·2024-11-20

    Halyard Surgical Kit Components May Shed Metal Flakes

    AVID Medical is recalling Halyard ANGIO ARTERIOGRAM PACK surgical kits due to metal flakes that may detach from forceps and clamps. Metal fragments could enter a patient's surgical site and cause local or foreign body reactions.

    Product
    Halyard ANGIO ARTERIOGRAM PACK - Medical convenience kits Model Number: MMCC004-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0356-2025·2024-11-20

    UA Kit Specimen Containers Identified as Non-Sterile Despite Sterile Labeling

    MEDLINE's UA Kit specimen containers are labeled as sterile but have been identified as non-sterile, posing a risk of contaminated specimens that could lead to incorrect test results and unnecessary treatment.

    Product
    UA KIT, SKU DYKM1690A; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0349-2025·2024-11-20

    Surgical hip procedure kit recalled for incomplete product seals

    Medline is recalling CARROLLTON HIP FX surgical kits due to incomplete seals on items within the kit. Affected units contain Lot Number 24EBP466 and were distributed in Tennessee.

    Product
    CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0416-2025·2024-11-20

    Halyard Extremity Pack Surgical Instruments Recalled for Loose Metal Flakes

    AVID Medical recalls Halyard Extremity Pack surgical instruments (model MMOK009-03) because small metal flakes may detach from sponge forceps and towel clamps and enter patients' surgical sites. No injuries have been reported.

    Product
    Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0392-2025·2024-11-20

    Halyard cardiac surgical kit recalled for loose metal flakes risk

    AVID Medical is recalling Halyard cardiac surgical kits (Model ESJH017-03) due to sponge forceps and towel clamps that may shed small metal flakes during surgery. These metal flakes could enter the patient's surgical site, potentially causing local or foreign body reactions.

    Product
    Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Model Number: ESJH017-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0407-2025·2024-11-20

    Surgical instrument bundle recalled for potentially detachable metal flakes

    AVID Medical is recalling Halyard VAG hysterectomy instrument bundles due to loose metal flakes on surgical instruments that could contaminate surgical sites.

    Product
    Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2025·2024-11-20

    Halyard EYE PLASTIC TRAY Medical Kits Recalled for Loose Metal Flakes

    AVID Medical recalls Halyard EYE PLASTIC TRAY medical kits due to loose metal flakes in sponge forceps and towel clamps. Metal flakes may contaminate surgical sites, potentially causing foreign body reactions or local tissue damage.

    Product
    Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0347-2025·2024-11-20

    Approach Hydro ST Micro Wire Guide Recalled for Incorrect Expiration Dates

    Cook Incorporated is recalling Approach Hydro ST Micro Wire Guide devices because affected device labels contain incorrect expiration dates. Using mislabeled devices beyond their actual expiration creates a risk of device failure and patient harm.

    Product
    Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0463-2025·2024-11-20

    Operating Table May Stop Unexpectedly During Surgery Due to Control Error

    MEERA CL mobile operating tables may experience an error code that causes the table to stop moving unexpectedly during surgery, resulting in procedural delays.

    Product
    MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 700001F0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0409-2025·2024-11-20

    Medical Convenience Kits Recalled for Detachable Metal Flakes

    AVID Medical recalls Halyard TAH-BUNDLE medical kits with sponge forceps and towel clamps. Loose metal flakes may detach and enter surgical sites, potentially causing local or foreign body reactions.

    Product
    Halyard TAH-BUNDLE - Medical convenience kits Model Number: LANC039-29
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0390-2025·2024-11-20

    Halyard Total Knee Surgical Kit Recalled for Loose Metal Flakes

    AVID Medical is recalling Halyard total knee surgical kits due to loose metal flakes on sponge forceps and towel clamps that could enter and contaminate the surgical site. The defect poses a risk of local reactions or foreign body complications.

    Product
    Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0400-2025·2024-11-20

    Surgical procedure kits recalled due to loose metal flakes in instruments

    AVID Medical is recalling Halyard BASIC PROCEDURE PACK surgical instrument kits because sponge forceps and towel clamps may contain loose metal flakes that could enter a patient's surgical site and cause local or foreign body reactions.

    Product
    Halyard BASIC PROCEDURE PACK - Medical convenience kits Model Number: GRAN019-06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0427-2025·2024-11-20

    Surgical forceps and clamps recall due to potential loose metal flakes

    AVID Medical is recalling Halyard OR Endovascular Tray surgical kits due to loose metal flakes that could detach from forceps and clamps and potentially enter the surgical site.

    Product
    Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0450-2025·2024-11-20

    Surgical kits recalled for potentially detachable metal flakes

    AVID Medical is recalling Halyard VA lumbar laminectomy surgical kits because sponge forceps and towel clamps may have loose metal flakes that could detach and enter a patient's surgical site.

    Product
    Halyard VA LUMBAR LAMINECTOMY - Medical convenience kits Model Number: VMED009-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0402-2025·2024-11-20

    Medical surgical kits recalled for loose metal flakes in instruments

    AVID Medical is recalling Halyard CYSTO PDS medical convenience kits due to loose metal flakes that may detach from sponge forceps and towel clamps. These flakes could enter a surgical site and cause foreign body reactions.

    Product
    Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0387-2025·2024-11-20

    Halyard Open Heart Surgical Kits Recalled for Loose Metal Flakes in Instruments

    AVID Medical is recalling Halyard Open Heart Pack Main surgical kits because sponge forceps and towel clamps may contain loose metal flakes that could detach and enter a patient's surgical site.

    Product
    Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02
    Category
    Medical Device
    Distribution
    Distributed nationwide