The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

27876–27900 of 32242

  • SevereFDA (Devices)·Z-1685-2013·2013-07-17

    Integra Hallu-Fix Cannulated Screw Driver Recall Due to Tip Breakage

    Integra LifeSciences is recalling Hallu-Fix cannulated screw drivers and tips because the tips have been reported to break during surgery.

    Product
    Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1693-2013·2013-07-17

    Fresenius Hemodialysis Machine O-Rings Recalled for Incorrect Material

    Fresenius Medical Care is recalling 725 replacement O-rings for hemodialysis machines because they were made of nitrile rubber instead of the required EPDM material.

    Product
    Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-741-2013·2013-07-17

    Olympia Pharmacy Recalls Hippiron Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling two lots of Hippiron 20 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Hippiron 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-768-2013·2013-07-17

    Olympia Pharmacy Recalls Pentosan Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling three vials of compounded Pentosan 250 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Pentosan 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-772-2013·2013-07-17

    Olympia Pharmacy Recalls Phenylephrine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Phenylephrine 1 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Phenylephrine 1 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-711-2013·2013-07-17

    Cal-Phos 1000 Injection Recalled Due to Sterility Concerns

    Olympia Pharmacy is recalling Cal-Phos 1000 Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Cal-Phos 1000 Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-760-2013·2013-07-17

    Olympia Pharmacy Recalls MICC Injections Due to Sterility Concerns

    Olympia Pharmacy is recalling MICC and MICC 25/50/330 injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    MICC (Methionine, Inositol, Choline, Cyanocobalamin, Chromium) Inj and MICC 25/50/330 Inj, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-720-2013·2013-07-17

    Dexpanthenol Injection Recalled for Lack of Sterility Assurance

    Olympia Pharmacy is recalling Dexpanthenol 250 mg/ml Injection due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Dexpanthenol 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-710-2013·2013-07-17

    Olympia Pharmacy Recalls Calcium Gluconate Due to Sterility Concerns

    Olympia Pharmacy is recalling Calcium Gluconate 23% because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Calcium Gluconate 23%, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-712-2013·2013-07-17

    Olympia Pharmacy Recalls Ceftiofur Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Ceftiofur GM vials because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Ceftiofur GM vial 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-770-2013·2013-07-17

    Olympia Pharmacy Recalls Phentolamine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling five vials of Phentolamine 20 mg/ml Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.

    Product
    Phentolamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-732-2013·2013-07-17

    Gentamicin Injection Recalled for Lack of Sterility Assurance

    Olympia Pharmacy is recalling Gentamicin 0.3% Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Gentamicin 0.3% Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-700-2013·2013-07-17

    Olympia Pharmacy Recalls Aminophylline Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Aminophylline 2.5% Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.

    Product
    Aminophylline 2.5% Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1595-2013·2013-07-17

    Granna's Tuna Mac and Vegetable Products Recalled for Undeclared Egg

    Granna's, LLC is recalling specific Tuna Mac, Italian Blend Vegetables, and Spiced Apple Rings products due to undeclared egg. All affected packages were distributed in Oklahoma.

    Product
    Granna's 412 Main, Bessie, Oklahoma 705 Tuna Mac, Italian Blend Vegetables & Spiced Apple Rings
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-765-2013·2013-07-17

    Olympia Pharmacy Recalls Papaverine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling six vials of Papaverine 40 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Papaverine 40 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-729-2013·2013-07-17

    Olympia Pharmacy Recalls Fluphenazine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Fluphenazine 25 mg/ml Injection because FDA inspection findings raised concerns about quality control and assurance of sterility.

    Product
    Fluphenazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-728-2013·2013-07-17

    FDA Recalls Compounded Estradiol and Testosterone Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling compounded Estradiol Cypionate and Test Cyp injections due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Estradiol Cypionate 2 mg/ml Test Cyp 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-731-2013·2013-07-17

    Olympia Pharmacy Recalls Compounded Gaba Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling compounded Gaba injections due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Gaba 50 mg/Mag Sulfate 50 mg/Taurine/Theanine 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1643-2013·2013-07-17

    Caribena Brand Papayas Recalled Due to Potential Salmonella Contamination

    Caribe Produce is recalling Caribena Brand papayas from Mexico due to potential Salmonella contamination. The product was distributed in New Jersey and North Carolina.

    Product
    Caribena Brand papayas packed in 35 lb. cartons marked with the brand "Caribena" and "Product of Mexico" stamped on the side. Each papaya bears a label which states "3112 CARIBENA Papaya MARADOL PRODUCT OF MEXICO www.grandeproduce.com" Papayas are packed in boxes of 8-12…
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-721-2013·2013-07-17

    Olympia Pharmacy Recalls Dextrose 50% Solution Due to Sterility Concerns

    Olympia Pharmacy is recalling Dextrose 50% Solution because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Dextrose 50% Solution, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-775-2013·2013-07-17

    Olympia Pharmacy Recalls Praziquantel Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Praziquantel 56.8mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Praziquantel 56.8mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-724-2013·2013-07-17

    Olympia Pharmacy Recalls Disodium EDTA Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Disodium EDTA Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.

    Product
    Disodium EDTA Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-779-2013·2013-07-17

    Olympia Pharmacy Recalls Sermorelin/GHRP Vials Due to Sterility Concerns

    Olympia Pharmacy is recalling Sermorelin/GHRP vials because FDA inspection findings raised concerns about quality control processes and assurance of sterility.

    Product
    Sermorelin/GHRP 3 mg/3 mg vial, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-747-2013·2013-07-17

    Olympia Pharmacy Recalls L-Arginine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling L-Arginine 200 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    L-ArGiNINE 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide