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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801–825 of 5100

  • 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
  • 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
  • CriticalFDA (Devices)·Z-0310-2025·2024-11-20

    Monoject Insulin Syringes Recalled for Incompatibility with Needleless IV Connectors

    Cardinal Health recalled approximately 371,326 Monoject U-100 insulin syringes due to incompatibility with needleless IV connectors. Affected units should not be used for IV push insulin administration via these connectors.

    Product
    Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0303-2025·2024-11-20

    Boston Scientific POLARx Cryoablation Catheters Instructions Updated for Atrio-esophageal Fistula Risk

    Boston Scientific issued a Class I recall of POLARx and POLARx FIT Cryoablation Balloon Catheters. Instructions for use are being updated due to risk of atrio-esophageal fistula, a serious complication.

    Product
    Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0304-2025·2024-11-20

    Draeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure

    Draeger Medical is recalling the Atlan A350 anesthesia workstation due to failures of the piston ventilator that either occurred before use or during patient anesthesia. Approximately 1,492 units are affected.

    Product
    Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0294-2025·2024-11-20

    Aeris EVO Ventilator May Develop Flow Sensor Fouling from Aerosols

    Philips Respironics Aeris EVO ventilators may accumulate aerosol deposits on the internal flow sensor, potentially causing inaccurate flow measurements.

    Product
    Aeris EVO. Model Number: VT2110X24B. 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
  • 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-0406-2025·2024-11-20

    AVID Medical Recalls Halyard C Section Bundles Due to Metal Flakes

    AVID Medical, Inc. is recalling Halyard C Section Bundles because small metal flakes may detach from sponge forceps and towel clamps, posing a risk of foreign body reactions.

    Product
    Halyard C SECTION BUNDLE - Medical convenience kits Model Number: LANC015-34
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0290-2025·2024-11-20

    Trilogy Evo O2 Ventilators Recalled for Potential Flow Sensor Malfunction

    Philips Respironics recalled 24,249 Trilogy Evo O2 ventilators because in-line nebulizer configurations may allow aerosol deposits to accumulate on the device's flow sensor, potentially causing inaccurate flow measurements.

    Product
    Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pedi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0300-2025·2024-11-20

    Boston Scientific POLARx FIT cryoablation catheter instructions updated for fistula risk

    Boston Scientific updated instructions for use of its POLARx and POLARx FIT cryoablation catheters, affecting 960 units distributed worldwide, in response to atrio-esophageal fistula risk.

    Product
    Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0298-2025·2024-11-20

    FDA Updates POLARx Cryoablation Catheter Instructions for Atrio-esophageal Fistula Risk

    Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation catheters to address atrio-esophageal fistula risks. The FDA classified this as a Class I recall affecting approximately 20,290 units distributed worldwide.

    Product
    Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0299-2025·2024-11-20

    Cryoablation Balloon Catheter Instructions Updated for Atrio-esophageal Fistula Risk

    Boston Scientific is updating instructions for use of POLARx and POLARx FIT Cryoablation Balloon Catheters to address atrio-esophageal fistula risk. Approximately 5,913 units have been distributed worldwide.

    Product
    Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
    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-0295-2025·2024-11-20

    Ventilator Model LD2110X23B Recalled for Potential Sensor Measurement Failure

    Philips Respironics is recalling 1,322 Garbin Evo ventilators (Model LD2110X23B) worldwide due to potential aerosol accumulation that could cause inaccurate flow sensor readings, posing a risk to patient care.

    Product
    Garbin Evo. Model Number: LD2110X23B. 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
  • SevereFDA (Devices)·Z-0357-2025·2024-11-20

    Medline Recalls Non-Sterile Urinalysis Kit Specimen Containers

    Medline Industries is recalling 626,305 urinalysis kits because the specimen containers are labeled sterile but are non-sterile, posing a risk of unnecessary treatment or hospitalization.

    Product
    URINALYSIS KIT 4, SKU DYLAB1021; Component No. 503581
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0404-2025·2024-11-20

    AVID Medical Recalls Halyard Laparoscopy Trays Due to Metal Flakes

    AVID Medical is recalling 42 Halyard Laparoscopy Trays because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.

    Product
    Halyard LAPAROSCOPY TRAY - Medical convenience kits Model Number: LANC006-25
    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-0291-2025·2024-11-20

    Philips Trilogy Evo ventilators recall: flow sensor fouling risk

    Philips Respironics is recalling Trilogy Evo ventilators due to potential aerosol deposits on the internal flow sensor, which could cause inaccurate flow measurements during ventilation.

    Product
    Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB2110X15B, ND2110X15B, ES2110X15B, IA2110X15B, IT2110X21B, KR2110X15B, TR2110X15B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0305-2025·2024-11-20

    Anesthesia workstation piston ventilator may fail before or during use

    Draeger Medical is recalling Atlan A350XL anesthesia workstations due to potential piston ventilator failure that may occur before use or during mechanical ventilation.

    Product
    Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0312-2025·2024-11-20

    FHC microTargeting Insertion Tube Set Recalled for Spacer Defect

    FHC, Inc. recalls microTargeting Insertion Tube Set Lot 244517, affecting 40 units distributed domestically. The oversized spacer tube component risks intracranial hemorrhaging during neurosurgical procedures.

    Product
    microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to accurately guide a microelectrode or instrument in the brain during stereotactic functional neurosurgical procedures.
    Category
    Medical Device
    Distribution
    6 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
  • SevereFDA (Devices)·Z-0292-2025·2024-11-20

    Trilogy Evo Universal Ventilator Recalled Due to Sensor Malfunction Risk

    Trilogy Evo Universal Ventilators (Model DS2000X11B) are recalled because in-line nebulizer configuration in certain locations could cause aerosol accumulation on the internal flow sensor, potentially resulting in inaccurate measurements.

    Product
    Trilogy Evo Universal Ventilator. Model Number DS2000X11B. 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
  • 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
  • CriticalCPSC·25046·2024-11-14

    Medical King adult bed rails recalled for entrapment and asphyxia hazard

    Medical King bed rails (about 222,000 units) are being recalled because they can trap users between the rail and mattress, posing asphyxiation risk. One death has been reported.

    Product
    Medical King Bed Assist Rail adult bed rails
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0227-2025·2024-11-13

    Elekta Disposable Biopsy Needles Recalled for Internal Debris Contamination

    Elekta recalls disposable biopsy needles for the Leksell Stereotactic System due to microscopic stainless steel debris found inside the needles. 111 kits (666 needles) distributed across multiple U.S. states are affected.

    Product
    Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465,
    Category
    Medical Device
    Distribution
    11 states