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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

4026–4050 of 13543

  • SevereFDA (Devices)·Z-0714-2025·2025-01-22

    Endoscopic Access Overtube Recalled for Risk of Obstruction and Pressure Buildup

    Trokamed is recalling a 20 Fr. endoscopic access overtube due to risk of obstruction and dangerous kidney pressure buildup during procedures. If inflow speed is too quick, rapid fluid flow can restrict outflow and cause intrarenal pressure to accumulate.

    Product
    Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access overtube.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0822-2025·2025-01-22

    ACCOLADE DR Pacemakers Recalled for Unintended Safety Mode Activation

    Boston Scientific is recalling ACCOLADE DR Pacemakers built before September 2018 due to risk of unintended Safety Mode activation caused by battery impedance issues. The devices may enter Safety Mode during normal telemetry operations.

    Product
    ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0831-2025·2025-01-22

    Dialysis Blood Circuit May Cause Excessive Fluid Removal

    The AquaFlexFlow UF 500 Plus blood circuit may malfunction and remove excessive fluid from patients, causing a dangerous drop in blood volume. This risk is especially dangerous for pediatric patients.

    Product
    nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0905-2025·2025-01-22

    Olympus MAJ-891 Forceps Recalled for Potential Biomaterial Retention During Reprocessing

    Olympus recalls the MAJ-891 endoscope forceps/irrigation plug nationwide because improper reprocessing may leave biomaterial inside the device, creating a contamination risk.

    Product
    Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0765-2025·2025-01-22

    Medline Fluid Delivery Sets Recalled Due to Assembly Error

    Medline Fluid Delivery Sets were incorrectly assembled with macro drip chambers instead of required micro drip chambers. The macro chamber delivers three times more fluid per drop, creating a risk of dosing errors.

    Product
    Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNEDY HLTH, Item Number: 65111341; 3) MTO,ANGIO,SINGLE,SPIKE,KIT, Item Number: 65232486; 4) MTO,ANGIO,SINGLE,SPIKE,KIT,GOOD,SAM, Item
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0716-2025·2025-01-22

    Endoscopic Access Overtube Sheath Recalled Due to Pressure Buildup Risk

    Trokamed GmbH is recalling an endoscopic access overtube sheath due to risk of intrarenal pressure buildup when inflow speed is too fast. No injuries reported.

    Product
    Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access overtube.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0827-2025·2025-01-22

    VISIONIST CRT-P Pacemakers Recalled Due to Battery Impedance Risk

    Certain VISIONIST CRT-P pacemakers with latent high battery impedance may initiate Safety Mode unexpectedly during normal operations. Manufactured before September 2018, 156,329 units were distributed worldwide.

    Product
    VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0715-2025·2025-01-22

    Endoscopic Access Sheath Recalled Due to Risk of Intrarenal Pressure Buildup

    Trokamed GmbH is recalling an endoscopic access sheath (18 Fr., 130 mm) used in gastroenterology and urology. Rapid fluid inflow may block outflow and cause dangerous pressure buildup inside the kidney.

    Product
    Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access overtube.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0713-2025·2025-01-22

    Endoscopic Access Overtube May Cause Dangerous Pressure Buildup During Procedures

    Trokamed's endoscopic access overtube may cause rapid pressure buildup in the kidney if inflow speed is too fast. The device can become obstructed by tissue and blood fragments, restricting outflow.

    Product
    Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0764-2025·2025-01-22

    Medline Fluid Delivery Sets incorrectly assembled with wrong drip chamber

    Medline fluid delivery sets were assembled with a macro drip chamber instead of the required micro drip chamber, delivering three times more fluid per drop and risking patient fluid overload.

    Product
    Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, Item Number 949000224; 4) FDS,135,NV,MICRO-CHAMBER,W/FILTER,RE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0829-2025·2025-01-22

    Impella RP Heart Pump Recalled Due to Optical Sensor Damage Risk

    Abiomed is recalling 1,560 units of the Impella RP with SmartAssist pump due to risk of optical sensor damage from device interactions. Damaged sensors may cause temporary or permanent pump malfunction.

    Product
    Impella RP with SmartAssist; Product Number: 0046-0035;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0821-2025·2025-01-22

    Neo-Tee Resuscitator Spring Defect May Impair Pediatric Ventilation

    Mercury Medical is recalling the Neo-Tee T-Piece Resuscitator due to an undersized spring in the circuit flow controller that may prevent reaching proper pressure ranges, potentially impairing emergency ventilation.

    Product
    Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0885-2025·2025-01-22

    Welch Allyn Life2000 Ventilator Battery Charger May Cause Device Inoperability

    Baxter Healthcare is recalling 946 Welch Allyn Life2000 ventilators due to a battery charger defect that can trigger an alarm and render the device inoperable.

    Product
    Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0856-2025·2025-01-22

    8MM Maryland Bipolar Forceps Recalled Due to Frayed Grip Cables

    Intuitive Surgical is recalling 8MM Maryland Bipolar Forceps due to increased complaints about frayed or broken grip cables on these reusable surgical instruments. Approximately 7,132 units have been distributed.

    Product
    8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0850-2025·2025-01-22

    Intuitive Surgical Recalls 8MM Surgical Scissors for Grip Cable Defects

    Intuitive Surgical is recalling 4,259 units of 8MM round tip scissors due to complaints of frayed or broken grip cables. The defect could affect instrument reliability during surgical procedures.

    Product
    8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 470007
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0908-2025·2025-01-22

    Cardinal Health Presource Surgical Kits Recalled for Endotoxin Contamination

    Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. No illnesses have been reported.

    Product
    Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910; 4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911; 5) KIT,ORP PLASTIC FLAP,Catalog Number PWHD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2025·2025-01-22

    Intuitive Surgical Needle Driver Recall Due to Grip Cable Failures

    Intuitive Surgical is recalling 8MM Large Suture Cut Needle Drivers (Model 471296) due to complaints of frayed or broken grip cables. Affected instruments may lose functionality during surgical use.

    Product
    8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0942-2025·2025-01-22

    ECONO STERILE medical procedure kits recalled for sterile barrier breach risk

    Sklar Instruments recalls ECONO STERILE blackhead extractor kits (Model 96-2395M) due to packaging issues that may compromise the sterile barrier. Affected units nationwide should not be used.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2025·2025-01-22

    Surgical Retractor Instruments Recalled Due to Frayed or Broken Grip Cables

    Intuitive Surgical is recalling approximately 9,303 units of 8MM Small Grasping Retractor instruments due to increased complaints of frayed or broken grip cables affecting reusable surgical instruments distributed nationwide and internationally.

    Product
    8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0958-2025·2025-01-22

    Change Healthcare Cardiology Hemo software autosave defect recall

    A software defect in Change Healthcare Cardiology Hemo software may cause clinicians to administer incorrect medications. The defect affects the autosave mechanism in affected versions.

    Product
    Change Healthcare Cardiology Hemo software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0941-2025·2025-01-22

    Sklar Instruments Sterile Surgical Kits Recalled for Packaging Defects

    Sklar Instruments is recalling 252,865 sterile surgical kits nationwide due to packaging defects that may compromise the sterile barrier, risking instrument contamination.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918; 2) ECONO STERILE METZENBAUM SCIS STR 9"STER C25,Model Number 941-1556; 3) ECONO STERILE MAYO SCISS STRT STRL 9" CS/25,Model Number 941-1613; 4) ECONO ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0918-2025·2025-01-22

    Portrait Core Services Software Loss of Patient Monitoring After 425 Days

    A software issue in GE's Portrait Core Services medical device software causes loss of patient monitoring capability in the Portrait Central Viewer Application after 425 days of continuous operation.

    Product
    Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0902-2025·2025-01-22

    VITROS DGXN Slides Recalled Due to Hemoglobin Interference in Digoxin Measurement

    VITROS DGXN Slides are recalled because hemoglobin can interfere with digoxin measurement, producing artificially low results. Approximately 1,541 units were distributed in the US and internationally.

    Product
    Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0837-2025·2025-01-22

    Karl Storz Biopsy and Grasping Forceps Recalled Due to Sterility Validation Failure

    Karl Storz Endoscopy is recalling 285 units of optical biopsy and grasping forceps (REF 723400) distributed across 31 US states due to failure of manual cleaning validation, which compromises sterility assurance.

    Product
    Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
    Category
    Medical Device
    Distribution
    32 states