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.

32226–32250 of 50502

  • HighFDA (Drugs)·D-0781-2017·2017-05-24

    Key Pharmacy Recalls SOD Phenylbutyrate Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 91 vials of SOD Phenylbutyrate injections due to a lack of assurance of sterility.

    Product
    SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx only, 30 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0734-2017·2017-05-24

    Key Pharmacy Recalls Compounded PGE1/PAP Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling specific lots of compounded PGE1/PAP injection because the firm cannot assure the sterility of the product.

    Product
    PGE1/PAP 10/30 5ML MDV MCG/MG/ML INJ, Injection, 10mg/30mg/mL, Rx only, 5mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0708-2017·2017-05-24

    Key Pharmacy Recalls 5-MTHF Injections Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling 5-MTHF 10mL multiple-dose vials due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.

    Product
    5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2087-2017·2017-05-24

    Aesculap ELAN 4 Diamond Burrs Recalled for Particulate Breakage

    Aesculap Implant Systems LLC is recalling 608 ELAN 4 diamond burrs because particulates may break off and enter the surgical site, potentially causing foreign body reactions or tissue damage.

    Product
    GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2,3; GP165R; ELAN 4 1-RING DIAMOND BURR COARSE D3,0; GP166R; ELAN 4…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2089-2017·2017-05-24

    Aesculap Hi-Line XS Diamond Burrs Recalled for Particulate Breakage Risk

    Aesculap Implant Systems LLC is recalling 608 Hi-Line XS Diamond Burrs because diamond particulates may break off and fall into the surgical site, potentially causing foreign body reactions or soft tissue damage.

    Product
    GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM; GE526R; HI-LINE XS DIAMOND BURR X-CRS.II D4.5MM; GE526SU; HI-LINE XS DISP.DIAM.BURR X-CRS.II D4.5; GE626R; HI-LINE XS DIAMOND BURR X-CRS.III D4.5MM; GE626SU; HI-LINE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2095-2017·2017-05-24

    BioMerieux Recalls ETEST ETP32 Ertapenem Strips Due to False Results

    BioMerieux SA is recalling ETEST ETP32 (Ertapenem) strips because they may produce false susceptible results, potentially leading to incorrect antibiotic treatment.

    Product
    ETEST ETP32 (Ertapenem) Ref. 531640, 531600, blister packaging ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria (Only 531640 was distributed in the United States)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0723-2017·2017-05-24

    Key Pharmacy Recalls Hydroxo-B12 Inhalation Solution Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling Hydroxo-B12 inhalation solution because the firm cannot assure the sterility of the product.

    Product
    HYDROXO-B12 INH PF GV 5MG/ML SOLN, Inhalation Solution, 5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2223-2017·2017-05-24

    Kemps Recalls Frozen Yogurt and Ice Cream for Plastic Contamination

    Kemps is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.

    Product
    Kemps YO2 Frozen Yogurt Cold Brewed Coffee, One Pint, UPC 41483-04122
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-2111-2017·2017-05-24

    Zimmer Werber Countersink Instruments Recalled Due to Material Defect

    Zimmer GmbH is recalling Werber Countersink instruments because raw material defects caused device damage.

    Product
    Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2153-2017·2017-05-24

    Raley's Muesli Cereal Recalled for Missing Coconut Allergen Labeling

    Raley's is recalling Muesli Chocolate Curlcrunch Cereal because an internal review found coconut was not listed in the allergen declaration.

    Product
    RALEY'S MUESLI CHOCOLATE CURLCRUNCH CEREAL; 12 oz. box - foil bag inside paper box. UPC: 46567-02266;Product Distributed by Raley's, West Sacramento, CA;Product of Switzerland
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2088-2017·2017-05-24

    Aesculap ELAN 4 Diamond Burrs Recalled for Particulate Breakage Risk

    Aesculap Implant Systems LLC is recalling ELAN 4 2-Ring Diamond Burrs because diamond particulates may break off and enter the surgical site, potentially causing foreign body reactions or tissue damage.

    Product
    GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0; GP324R; ELAN 4 2-RING DIAMOND BURR COARSE D5.0; GP325R; ELAN 4 2-RING DIAMOND BURR COARSE D6.0; Product Usage: The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2226-2017·2017-05-24

    Kemps Recalls Frozen Yogurt and Ice Cream Due to Plastic Contamination

    Kemps is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.

    Product
    Kemps YO2 Frozen Yogurt Chocolate Peanut Butter Fudge, One Pint, UPC 41483-04126
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-2103-2017·2017-05-24

    Medline 16 mm Distraction Pin Recalled Due to Sterile Seal Integrity

    Medline Industries is recalling 198 packs of 16 mm Distraction Pins because the sterile packaging seal may be compromised, risking loss of sterility.

    Product
    16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2202-2017·2017-05-24

    Wegman's O'Brien Hash Browns Recalled for Foreign Material Contamination

    McCain Foods USA is recalling Wegman's O'Brien Hash Browns because the product may contain hard plastic or rubber pieces from golf balls.

    Product
    Wegman's O'Brien Hash Browns, frozen packages, net wt. 28 oz. UPC 07789036523.
    Category
    Food
    Distribution
    6 states
  • HighCPSC·17158·2017-05-24

    Leggett & Platt Recalls Office Chairs Due to Fall Hazard

    Leggett & Platt is recalling about 47,900 office chairs in the U.S. because seat slider bolts can disconnect, causing the seat to detach and posing a fall hazard.

    Product
    Office chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2017·2017-05-24

    Medline 14 mm Distraction Pin Recalled for Potential Sterility Loss

    Medline Industries is recalling 14 mm Distraction Pins due to potential sterile packaging seal failures that could compromise device sterility.

    Product
    14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2017·2017-05-24

    Bausch & Lomb Recalls SoftPort Easy-Load Lens Delivery System

    Bausch & Lomb is recalling specific lots of the SoftPort Easy-Load Lens Delivery System due to reports of kinked haptics during lens delivery.

    Product
    SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the folding and delivering of the LI61AO, LI61AOV, or LI61SE 3-piece lens into the eye. The SofPort Easy-Load Lens Delivery System consists of a syringe shaped body and tip with a plunger, drawer, and haptic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0785-2017·2017-05-24

    Key Pharmacy Recalls Vitamin D3 Injection Due to Sterility Concerns

    Key Pharmacy and Compounding Center is recalling Vitamin D3 in Olive Oil SDV 100,000U/mL Injection due to a lack of assurance of sterility.

    Product
    VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 100,000u/mL, Rx only, packaged in 1 mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2232-2017·2017-05-24

    Kemps Recalls Sweet Me Creamery Ice Cream Due to Plastic Contamination

    Kemps is recalling select pints of Sweet Me Creamery Ice Cream and YO2 Frozen Yogurt because they may contain pieces of plastic.

    Product
    Kemps Sweet Me Creamery Chocolate Peanut Butter Pretzel, One Pint, UPC 41483-04144
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-2100-2017·2017-05-24

    Mobius3D Software Recalled for Dose Calculation Defect in Radiation Therapy

    Mobius Medical Systems is recalling Mobius3D software versions 1.5.0 and 1.5.2 due to a code defect that may cause dose calculation discrepancies in radiation therapy.

    Product
    Mobius3D Product Usage: Mobius3D software is used for quality assurance and treatment plan verification in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans…
    Category
    Medical Device
    Distribution
    Distributed nationwide