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.

38476–38500 of 50506

  • HighFDA (Devices)·Z-1742-2015·2015-06-17

    Ortho-Clinical VITROS 4600 Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry System software versions 3.2 and below due to a defect that may allow multiple assays to be tested on a single urine specimen, potentially leading to biased patient results.

    Product
    VITROS 4600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2414-2015·2015-06-17

    FDA Recalls Kr8om Max Kratom Tablets Due to Kratom Content

    Nuevotanicals is recalling Kr8om Max2, Max5, and Max10 tablets because they contain Kratom. The products were distributed in 12 states.

    Product
    Kr8om Max2 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 2 tablets; Kr8om Max5 All-Natural Extraction, Formulation, and Distribution by NUEVOtanicals, LLC Fort Worth, TX 76112, 5 tablets; Kr8om Max10 All-Natural Extraction…
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-1773-2015·2015-06-17

    Philips Ingenuity CT Uninterruptible Power Supply Recall for Battery Acid Leakage

    Philips is recalling 156 Ingenuity CT Uninterruptible Power Supply (UPS) accessory devices due to a risk of battery acid leakage, overheating, and fume emission.

    Product
    Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1724-2015·2015-06-17

    Ortho-Clinical enGen Laboratory Automation System Recalled for Sample Handling Defects

    Ortho-Clinical Diagnostics is recalling 45 enGen Laboratory Automation Systems worldwide because recapper caps may fall off or tubes may be dropped, risking bio-hazardous fluid splashing and cross-contamination.

    Product
    enGen Laboratory Automation System (enGen System), Product Code ENGEN, configured with all of the following system components: Recapper Caps (Product Codes 952238 or 6844286 only), Recapper Module (230V) or Recapper Module (110V) (Product Codes 952036-EG or 952136-EG), Rack…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1765-2015·2015-06-17

    Philips CT Scanner UPS Accessory Recall for Battery Acid Leakage

    Philips Medical Systems is recalling 847 UPS accessory devices for CT scanners due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1762-2015·2015-06-17

    Philips Recalls Brilliance CT 40 Uninterruptible Power Supply Accessory Devices

    Philips Medical Systems is recalling 17 Brilliance CT 40 Uninterruptible Power Supply (UPS) accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Brilliance CT 40 - Slices (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2399-2015·2015-06-17

    Reaction Nutrition Recalls Pre-Workout Supplements Due to Undeclared Allergens

    Reaction Nutrition is recalling REACTION RECOR: Pre Action supplements because they may contain undeclared whey protein and soy.

    Product
    REACTION RECOR: Pre Action- 336g Orange Xplosion, Distributed by Reaction Nutrition, Carnegie, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2392-2015·2015-06-17

    Reaction Nutrition Recalls Bio Armor CreaMatrix for Undeclared Allergens

    Reaction Nutrition is recalling Bio Armor CreaMatrix supplements because they may contain undeclared whey protein and soy due to shared equipment use.

    Product
    Bio Armor CreaMatrix 60 servings Blue Raspberry, Distributed by Reaction Nutrition, Carnegie, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1715-2015·2015-06-17

    ASP Recalls EVOTECH Endoscope Cleaner Due to Connection Detection Failure

    Advanced Sterilization Products is recalling EVOTECH Endoscope Cleaner and Reprocessor units because they may fail to detect disconnected endoscopes, potentially allowing incomplete disinfection cycles.

    Product
    EVOTECH Endoscope Cleaner and Reprocessing System 220-230V, P/N 50004-002. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1782-2015·2015-06-17

    Philips Gemini LXL 16 Slice CT Systems Recalled for UPS Defects

    Philips is recalling 10 Gemini LXL 16 Slice CT systems worldwide due to UPS accessory defects that may cause battery acid leakage, overheating, or fumes.

    Product
    Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1760-2015·2015-06-17

    Philips MX 16 Slice Phase II CT Systems Recalled for UPS Battery Hazards

    Philips is recalling 11 MX 16 Slice Phase II CT systems because their UPS accessory devices may leak battery acid, overheat, or emit fumes.

    Product
    MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1793-2015·2015-06-17

    Philips CT Scanner UPS Accessory Recall for Battery Acid Leakage Risk

    Philips Medical Systems is recalling two Diamond Select Brilliance CT 16 systems due to a risk of battery acid leakage, overheating, and fumes from the UPS accessory.

    Product
    Diamond Select Brilliance CT 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1787-2015·2015-06-17

    Philips Recalls GEMINI TF PET/CT 64 Slice UPS Accessory Devices

    Philips Medical Systems is recalling 71 GEMINI TF PET/CT 64 Slice UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1748-2015·2015-06-17

    Remel Blood Agar Plates Recalled for Listeria monocytogenes Contamination

    Remel Inc is recalling specific lots of Blood Agar plates due to potential Listeria monocytogenes contamination. The products were distributed nationwide.

    Product
    Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100 plates). Blood agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1752-2015·2015-06-17

    Gyrus ACMI Diego Elite Tubeset Recalled for Sterility Assurance Concerns

    Gyrus Acmi is recalling Diego Elite Tubesets due to a potential lack of sterility assurance. The recall affects 12,020 boxes distributed in the US, Canada, and other countries.

    Product
    Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2396-2015·2015-06-17

    Reaction Nutrition Recalls Amino Action Supplements Due to Undeclared Whey

    Reaction Nutrition is recalling Amino Action supplements because they may contain undeclared whey protein due to shared equipment use.

    Product
    REACTION RECOR: Amino Action- 500g (Glacier Blue), Distributed by Reaction Nutrition, Carnegie, PA
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1730-2015·2015-06-17

    Smiths Medical Recalls Low Volume Extension Sets Due to Tubing Defect

    Smiths Medical is recalling 6,000 units of Low Volume Extension Sets because under-sized tubing was used in production. The affected product was distributed to five states.

    Product
    Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1792-2015·2015-06-17

    Philips Recalls BrightView XCT UPS Accessory Devices for Battery Acid Leakage

    Philips Medical Systems is recalling 337 BrightView XCT UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1772-2015·2015-06-17

    Philips Medical Systems Recalls Ingenuity Core 128 UPS Accessory Devices

    Philips Medical Systems is recalling 288 Ingenuity Core 128 UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1744-2015·2015-06-17

    Biomet Optigun Ratchet Cement Gun Recalled Due to Pin Disconnection Risk

    Biomet France is recalling three Optigun Ratchet cement guns because a pin may disconnect and be lost, potentially delaying surgery or requiring revision.

    Product
    The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1764-2015·2015-06-17

    Philips Recalls CT Scanner UPS Accessories Due to Battery Acid Leakage Risk

    Philips Medical Systems is recalling 126 UPS accessory devices for CT scanners due to risks of battery acid leakage, overheating, and fume emission.

    Product
    Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1775-2015·2015-06-17

    Philips Medical Systems Recalls AXIS UPS Accessory Devices for CT Systems

    Philips Medical Systems is recalling AXIS Uninterruptible Power Supply (UPS) accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.

    Product
    AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide