The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

10351–10375 of 88183

  • 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 (Food)·F-0130-2025·2024-11-20

    Home Chef Chicken Street Taco Recalled for Listeria Contamination

    The Kroger Co is recalling Home Chef Chicken Street Taco meal kits due to Listeria monocytogenes contamination in the cooked chicken. Approximately 24,072 units distributed across 31 states are affected.

    Product
    Home Chef Chicken Street Taco, Net Wt. 9.93 oz, packaged in a plastic tray with clear plastic lid, perishable item kept under refrigeration, UPC 84013430435, all lot codes
    Category
    Food
    Distribution
    31 states
  • 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-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-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-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-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-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-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 (Food)·F-0132-2025·2024-11-20

    Frozen Potato Wedges Recalled for Undeclared Wheat Allergen

    JR Simplot's frozen seasoned potato wedges are being recalled because the product contains wheat but the label does not declare this allergen. The affected product was distributed to retailers in Pennsylvania only.

    Product
    Item #473015 Simplot seasoned CRISP Delivery+ Savory 6 Cut Crinkle Cut Wedge, Frozen Potatoes, 5lb. bag without any labeling, 6 bags per case, SKU 10071179473015. Packaging Distribution Information: J.R. Simplot Company P.O. Box 9386, Boise, ID 83707. Ingredients: POTATOES…
    Category
    Food
    Distribution
    1 state
  • 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-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-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-0426-2025·2024-11-20

    Surgical Kit Components Recalled for Potential Metal Fragment Detachment

    AVID Medical is recalling Halyard ORAL SURGERY HEAD medical convenience kits (Model SAMM029-15) due to potential loose metal flakes that could detach from forceps and clamps and enter the surgical site, posing risk of local or foreign body reactions.

    Product
    Halyard ORAL SURGERY HEAD - Medical convenience kits Model Number: SAMM029-15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0417-2025·2024-11-20

    Halyard MINOR PACK Medical Kits Recalled for Loose Metal Fragments in Instruments

    AVID Medical is recalling Halyard MINOR PACK medical kits because sponge forceps and towel clamps may shed loose metal fragments. These could enter surgical sites undetected, potentially causing local or foreign body reactions.

    Product
    Halyard MINOR PACK - Medical convenience kits Model Number: MMOK013-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2025·2024-11-20

    MEERA CL Operating Table Error Code 50037 Causes Unexpected Stoppage

    The MEERA CL operating table may experience error code 50037, causing the table to unexpectedly stop during operation. This error occurs sporadically when controlled via an IR-Hand Control and may delay surgical procedures.

    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: 700001B0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0397-2025·2024-11-20

    Halyard surgical kit recalled for loose metal flakes in forceps and clamps

    AVID Medical is recalling Halyard KIT, SPINE surgical convenience kits due to loose metal flakes on sponge forceps and towel clamps. The flakes could detach and enter a patient's surgical site, potentially causing local or foreign body reactions.

    Product
    Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0422-2025·2024-11-20

    Halyard Interventional Tray Medical Kits Recalled for Loose Metal Flakes

    AVID Medical, Inc. is recalling the Halyard Interventional Tray medical kits because sponge forceps and towel clamps may shed small metal flakes. These loose flakes could enter a patient's surgical site undetected, causing local or foreign body reactions.

    Product
    Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0331-2025·2024-11-20

    VYGON 250 mL IV Fluid Containers Recalled for Leaks During Filling

    The Metrix Company is recalling VYGON 250 mL IV fluid containers that have been found to leak during filling. Leaking containers cannot properly contain intravenous fluid.

    Product
    VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2025·2024-11-20

    Venclose RF Ablation Catheters Recalled for Wiring Defect Causing Excessive Heat

    Bard Peripheral Vascular's Venclose RF ablation catheters may have swapped signal wires causing excessive heating. The defect can lead to temperatures exceeding therapeutic levels, increasing risk of thermal injury.

    Product
    The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0370-2025·2024-11-20

    Stryker Smoke Evacuation Pencils Recalled for Unintended Activation Risk

    Stryker is recalling 403,730 Neptune SafeAir Smoke Evacuation Pencil units because they may activate unexpectedly when plugged in, creating a risk of electrical burns to patients and physicians.

    Product
    Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2025·2024-11-20

    MEERA CL Mobile Operating Table Control Malfunction Recall

    The MEERA CL mobile operating table may experience error code 50037 that stops table movement during use, causing surgical procedure delays. Getinge recalled 342 units distributed worldwide.

    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: 720001B0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0415-2025·2024-11-20

    Halyard ORTHO PACK surgical instrument kits recalled due to metal flakes

    AVID Medical is recalling Halyard ORTHO PACK kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site, causing local or foreign body reactions.

    Product
    Halyard ORTHO PACK -Medical convenience kits Model Number: MMOK006-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2025·2024-11-20

    Halyard Angiography Pack Surgical Instruments Recalled Due to Loose Metal Flakes

    AVID Medical is recalling Halyard angiography pack surgical instruments due to loose metal flakes that could detach and enter a patient's surgical site, potentially causing foreign body reactions.

    Product
    Halyard ANGIOGRAPHY PACK - Medical convenience kits Model Number: MAMC218-18
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0384-2025·2024-11-20

    Halyard IR Biopsy Pack recalled for loose metal flakes in surgical kit

    AVID Medical is recalling Halyard IR BIOPSY PACK due to loose metal flakes in forceps and towel clamps that could detach and enter the surgical site, potentially causing local or foreign body reactions.

    Product
    Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01
    Category
    Medical Device
    Distribution
    Distributed nationwide