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.

25176–25200 of 50443

  • HighFDA (Devices)·Z-2201-2019·2019-08-14

    Abbott Alinity ci-series System Control Modules Recalled for Software Defect

    Abbott is recalling 943 Alinity ci-series System Control Modules because software may fail to detect issues in specific electrolyte assays.

    Product
    The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL MODULE Product Usage: The Alinity ci series System Control Module has a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2166-2019·2019-08-14

    Centurion Medical Recalls LVAD Dressing Kits Due to Sterile Packaging Concerns

    Centurion Medical Products Corporation is recalling 1,224 LVAD Dressing System kits because the sterile packaging may be compromised, posing a risk of infection.

    Product
    LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2019·2019-08-14

    Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues

    Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints about leaks, suction issues, and failure to obtain samples.

    Product
    EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7G - REF ECP017G.Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1987-2019·2019-08-14

    Milkweed & Monarch Recalls Herbal Teas Due to Salmonella Risk

    Milkweed & Monarch, LLC is recalling specific lots of Ginger Spice, Sandia Rose, and Honey Lavender herbal teas due to potential Salmonella contamination.

    Product
    Honey Lavender, 1 oz, 2 oz, 4 oz, and 1-3 lb packages. An herbal tea, Taos, NM
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-2095-2019·2019-08-14

    Gk Photonics Maxim Laser Projection Series Recalled for Safety Defect

    Gk Photonics is recalling the Maxim Laser Projection Series because the provided remote interlock dongle may not fully comply with FDA safety requirements, potentially exposing users to high-power laser radiation.

    Product
    Maxim Laser Projection Series
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2167-2019·2019-08-14

    Centurion Medical Recalls Daily Driveline Kits Due to Sterile Packaging Concerns

    Centurion Medical Products Corporation is recalling 3,250 Daily Driveline Kits because the sterile packaging may be compromised, posing a risk of infection.

    Product
    DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1985-2019·2019-08-14

    Milkweed & Monarch Recalls Ginger Spice Tea Due to Salmonella Risk

    Milkweed & Monarch, LLC is recalling specific lots of Ginger Spice, Sandia Rose, and Honey Lavender herbal teas due to potential Salmonella contamination.

    Product
    Ginger Spice, 1 oz (28.4 g), 2 oz, 4 oz, and 1-3 lb packages. An herbal tea, Taos, NM
    Category
    Food
    Distribution
    10 states
  • HighFDA (Drugs)·D-1609-2019·2019-08-14

    Herbal Doctor Remedies Recalls Lung Tonic EX Capsules for Manufacturing Deviations

    Herbal Doctor Remedies is recalling Lung Tonic EX Capsules because they were manufactured outside of required Good Manufacturing Practices controls.

    Product
    Lung Tonic EX Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2087-2019·2019-08-14

    Winco Foods Taco Seasoning Recalled for Potential Salmonella Contamination

    CH Guenther & Sons is recalling Winco Foods Taco Seasoning Mild because the cumin ingredient may be contaminated with Salmonella.

    Product
    Winco Foods, Taco Seasoning Mild, Net Wt. 1.25 OZ, Distributed by Winco Foods, LLC, Boise, ID, UPC 0 70552 90126 1
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-2172-2019·2019-08-14

    Centurion Laceration Tray Kits Recalled for Potential Sterile Packaging Compromise

    Centurion Medical Products is recalling Laceration Tray Kits because sterile packaging may be compromised, posing a risk of infection.

    Product
    LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceration repairs for general population.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2222-2019·2019-08-14

    MicroAire SmartRelease Endoscopic Carpal Tunnel Handpiece Recall

    MicroAire is recalling 103 SmartRelease Endoscopic Carpal Tunnel Release Handpieces because the blade may fail to retract when tightened.

    Product
    SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-2169-2019·2019-08-14

    Centurion Medical Recalls Driveline Management Tray Kits Due to Packaging Risk

    Centurion Medical Products is recalling 1,900 Driveline Management Tray Kits because sterile packaging may be compromised, posing a risk of infection.

    Product
    DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2163-2019·2019-08-14

    Centurion Medical Recalls Circumcision Trays Due to Sterile Packaging Concerns

    Centurion Medical Products Corporation is recalling 220 Circumcision Tray kits (Lot # 2019052190) because the sterile packaging may be compromised, posing a risk of infection during newborn procedures.

    Product
    CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performing circumcision procedures on newborns.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2214-2019·2019-08-14

    Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues

    Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints about leaks, suction problems, and failure to obtain tissue samples.

    Product
    EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7GV Upright (Vertical) - REF ECP017GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2212-2019·2019-08-14

    Bard EnCor Breast Biopsy Probes Recalled for Leaks and Suction Issues

    Bard Peripheral Vascular Inc is recalling 239 units of EnCor Breast Biopsy Probes due to reports of leaks, suction issues, and failure to obtain tissue samples.

    Product
    EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 12GV Upright (Vertical) - REF ECP0112GV. Product Usage: Indicated for use in acquiring tissue for diagnosing breast abnormalities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2105-2019·2019-08-14

    Comet Technologies Recalls YXLON Cheetah Cabinet X-Ray Systems

    Comet Technologies is recalling 77 YXLON Cheetah cabinet X-Ray systems because the door interlock fails to meet federal performance standards for power disconnection.

    Product
    YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2142-2019·2019-08-14

    Biomet 3i Recalls Certain Bellatek Titanium Abutments Due to Manufacturing Defect

    Biomet 3i is recalling 6 units of Certain Bellatek Titanium Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.

    Product
    CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2171-2019·2019-08-14

    Centurion Universal Block Tray Recalled for Potential Sterile Packaging Compromise

    Centurion Medical Products is recalling Universal Block Tray kits because sterile packaging may be compromised, posing a risk of infection during regional anesthesia.

    Product
    UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regional anesthesia nerve blocks for general population.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2156-2019·2019-08-14

    SenTec Membrane Changer Insert Recalled for Electrolyte Application Defect

    SenTec AG is recalling Membrane Changer Inserts due to a 5% chance of missing or reduced electrolyte application during sensor changes.

    Product
    SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2203-2019·2019-08-14

    Medline Recalls Endoscopic Cleaning Brushes Due to Detachment Risk

    Medline Industries is recalling endoscopic cleaning brushes because they may detach during use, potentially leaving parts inside endoscopes.

    Product
    Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in between patient procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2196-2019·2019-08-14

    Siemens Lantis 8.3 Commander Recalled for Windows RDP Vulnerability

    Siemens is recalling two Lantis 8.3 Commander units due to a Microsoft Windows Remote Desktop Protocol vulnerability.

    Product
    Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient…
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Drugs)·D-1689-2019·2019-08-14

    RXQ Compounding Recalls Niacinamide Vials Due to Sterility Concerns

    RXQ Compounding LLC is recalling Niacinamide 100mg/mL vials because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.

    Product
    NIACINAMIDE 100MG/ML, 10ML per vial, RXQ Compounding, 340 West State Street, Unit 9, Athens, OH 45701. NDC: 70731-0938-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2164-2019·2019-08-14

    Centurion Medical Recalls Circumcision Kits Due to Sterile Packaging Concerns

    Centurion Medical Products Corporation is recalling 168 Circumcision Tray kits because sterile packaging may be compromised. The kits are used for newborn circumcision procedures.

    Product
    CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on newborns.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2173-2019·2019-08-14

    Centurion Medical Recalls Suture Trays Due to Sterile Packaging Concerns

    Centurion Medical Products is recalling 48 SNAG FREE SUTURE TRAY kits because sterile packaging may be compromised, posing a risk of infection.

    Product
    SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for laceration repairs for general population.
    Category
    Medical Device
    Distribution
    Distributed nationwide