The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

8601–8625 of 22113

  • HighFDA (Devices)·Z-0929-2025·2025-01-22

    Surgical Retractor Kits Recalled for Potential Sterile Barrier Breach

    Sklar Instruments is recalling ECONO STERILE surgical retractor kits due to packaging defects that may result in a breach of the sterile barrier. 75 units nationwide have been affected.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A; 3) ECONO STERILE WEITLANER RETR BL 3X4 5.5"CS25, Model Numbers: 96-2207A;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0840-2025·2025-01-22

    Augustine HotDog Patient Warming Temperature Controller May Display Power-on Self-Test Error

    Augustine Temperature Management is recalling 817 units of its HotDog Patient Warming Temperature Management Controllers for a power-on self-test error code EA POST.

    Product
    Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-0953-2025·2025-01-22

    ECONO STERILE Orthopedic Probes Recalled for Sterile Barrier Breach Risk

    Sklar Instruments recalls 2,500 ECONO STERILE orthopedic probe kits due to packaging issues that may breach the sterile barrier. No illnesses or injuries have been reported.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe
    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-0868-2025·2025-01-22

    Intuitive Surgical Bipolar Dissectors Recalled for Frayed Grip Cables

    Intuitive Surgical is recalling 141 curved bipolar dissectors due to complaints of frayed or broken grip cables on the reusable surgical instruments.

    Product
    8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0882-2025·2025-01-22

    Intuitive Surgical Bipolar Grasper Recall Due to Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 14,507 8MM Long Bipolar Graspers due to increased complaints of frayed or broken grip cables that could impair surgical control during laparoscopic procedures.

    Product
    8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0848-2025·2025-01-22

    Surgical Scissors Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 8MM Potts Scissors due to frayed or broken grip cables that could affect instrument performance during surgical procedures.

    Product
    8MM, POTTS SCISSORS, IS4000 REF 470001
    Category
    Medical Device
    Distribution
    0 states
  • 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
  • HighFDA (Devices)·Z-0896-2025·2025-01-22

    GE Healthcare Nuclear Medicine Systems Recalled Due to Detector Fall Risk

    GE Healthcare recalls certain nuclear medicine systems that could have been transported without proper detector support, risking detector falls and life-threatening injury.

    Product
    GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • 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-0865-2025·2025-01-22

    Reusable Surgical Instruments Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling reusable surgical instruments due to reports of frayed or broken grip cables that may affect safe operation during procedures.

    Product
    8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0889-2025·2025-01-22

    GE Healthcare Nuclear Medicine Systems Detector Fall Risk from Improper Transport

    GE Healthcare recalled 116 nuclear medicine imaging systems worldwide due to risk that systems transported without proper detector support could experience detector falls and life-threatening injury.

    Product
    GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, Emission
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0835-2025·2025-01-22

    Alcon Monarch III D Delivery Cartridge Recalled for Molding Defect Risk

    Alcon is recalling 41,718 units of its Monarch III D Delivery Cartridge due to a molding defect that could scratch the intraocular lens during cataract surgery.

    Product
    Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery cartridge Lens Guide, Intraocular Component: N/A
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0869-2025·2025-01-22

    Intuitive Surgical Fenestrated Grasper Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling its 8MM Tip-Up Fenestrated Grasper due to frayed or broken grip cables on reusable surgical instruments. The defect affects multiple batch numbers produced between 2023 and 2024.

    Product
    8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0954-2025·2025-01-22

    Surgical instrument kits recalled for potential sterile packaging defects

    Sklar Instruments is recalling 41,850 units of ECONO STERILE surgical procedure kits due to packaging defects that may compromise the sterile barrier, affecting multiple clamp and hemostat models used in general orthopedic surgery.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353; 3) ECONO STERILE OLSEN-HEGAR NH 5.5" STRL CS/25, Model Number 96-2355A; 4) ECO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0940-2025·2025-01-22

    ECONO STERILE Procedure Kits Recalled for Sterile Barrier Breach Risk

    Sklar Instruments is recalling ECONO STERILE medical procedure kits (Model 96-4921A) due to packaging issues that may result in a breach of the sterile barrier. The kits should not be used.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0901-2025·2025-01-22

    Digoxin Test Slides May Report Inaccurately Due to Hemoglobin Interference

    QUIDEL ORTHO is recalling VITROS DGXN test slides because hemoglobin can interfere with digoxin measurements at lower-than-expected levels, potentially causing inaccurate test results.

    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-0936-2025·2025-01-22

    ECONO STERILE Medical Procedure Kits Recalled for Sterile Barrier Compromise

    Sklar Instruments recalls ECONO STERILE medical procedure kits (300 units nationwide) due to packaging issues that may compromise sterile barrier integrity.

    Product
    ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAUS TWL CLP STER 5.25 25, Model Number 96-2636; general purpose clips
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0931-2025·2025-01-22

    Medical Procedure Kits Recalled for Potential Sterile Barrier Breach

    Sklar Instruments is recalling ECONO STERILE Curette Excavator surgical kits due to packaging issues that may compromise sterile barriers. Affected kits were distributed nationwide.

    Product
    ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0202-2025·2025-01-22

    FDA recalls glipiZIDE Extended-Release Tablets for failed dissolution specifications

    Amerisource Health Services LLC is recalling glipiZIDE Extended-Release Tablets, 2.5 mg, due to failed dissolution specifications. Patients should contact their pharmacist or healthcare provider.

    Product
    glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0852-2025·2025-01-22

    Intuitive Surgical DeBakey Forceps Recalled for Frayed or Broken Grip Cables

    Intuitive Surgical is recalling 1,739 8MM DeBakey Forceps (Model 470036) used in surgical procedures due to increased reports of frayed or broken grip cables. Cable failure could impair instrument function during surgery.

    Product
    8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
    Category
    Medical Device
    Distribution
    0 states