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.

27401–27425 of 32219

  • SevereFDA (Devices)·Z-0007-2014·2013-10-16

    Bard Recalls LifeStent Solo Vascular Stents Due to Deployment Issues

    Bard Peripheral Vascular is recalling specific lots of LifeStent Solo Vascular Stents due to a higher incidence of partial stent deployment.

    Product
    Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66295-001·2013-10-16

    Hospira Recalls Bupivacaine Hydrochloride Vials Due to Sterility Concerns

    Hospira is recalling 187,150 vials of Bupivacaine Hydrochloride with Epinephrine due to a lack of assurance of sterility and potential vial breakage.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2293-2013·2013-10-09

    MedStream Programmable Pump Recalled for Excessive Drug Flow Rates

    Codman & Shurtleff is recalling two MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.

    Product
    MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66241-001·2013-10-09

    Apothecary Shoppe Recalls Estradiol and Progesterone Injectable Due to Sterility Concerns

    The Apothecary Shoppe is recalling Estradiol and Progesterone injectable vials due to concerns about sterility assurance with its testing laboratory.

    Product
    Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2272-2013·2013-10-09

    King Systems Universal Flex2 Breathing Circuit Recalled for Latex Mislabeling

    King Systems Corp. is recalling Universal Flex2 Breathing Circuits that contain latex bags but are labeled as non-latex.

    Product
    Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2294-2013·2013-10-09

    MedStream Programmable Pump Recalled for Excessive Drug Flow Rates

    Codman & Shurtleff is recalling MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.

    Product
    MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2299-2013·2013-10-09

    Codman MedStream Programmable Pump Recalled for Excessive Drug Flow Rates

    Codman & Shurtleff, Inc. is recalling 369 MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.

    Product
    MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2297-2013·2013-10-09

    MedStream Refill Kit Recall for Excessive Drug Flow Rates

    Codman & Shurtleff is recalling MedStream Refill Kits because they may deliver drug flow rates exceeding programmed levels.

    Product
    MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1065-2013·2013-10-09

    AmeriSource Bergen Recalls Ifosfamide Injection Due to Temperature Abuse

    AmeriSource Bergen is recalling 49 vials of Ifosfamide Injection 1g/20mL because they were not properly refrigerated at distribution centers.

    Product
    Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4495-22
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66201-001·2013-10-09

    Hospira Recalls Lidocaine Ampuls Due to Visible Particulate Matter

    Hospira is recalling 86,400 ampuls of 5% Lidocaine HCl and 7.5% Dextrose Injection due to reports of visible particulates in the glass ampules.

    Product
    5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2300-2013·2013-10-09

    MedStream Programmable Pump Recalled for Excessive Drug Flow Rates

    Codman & Shurtleff, Inc. is recalling 735 MedStream Programmable Pumps because they may deliver drug flow rates exceeding programmed levels.

    Product
    MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66241-002·2013-10-09

    Apothecary Shoppe Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

    The Apothecary Shoppe is recalling 1,430 mL of Testosterone Cypionate 200 mg/mL Injectable in Oklahoma due to concerns about sterility assurance.

    Product
    SIH-Testosterone Cypionate 200 mg/mL Injectable, 10 mL sterile vial, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2296-2013·2013-10-09

    MedStream Refill Kit Recalled for Excessive Drug Flow Rates

    Codman & Shurtleff is recalling MedStream Refill Kits because they may allow drug flow rates to exceed programmed levels.

    Product
    MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1068-2013·2013-10-09

    Triangle Compounding Recalls Sodium Phosphate Injectable Due to Sterility Concerns

    Triangle Compounding is recalling 54 vials of Sodium Phosphate Injectable because laboratory results indicate microbial contamination and the sterility of the product cannot be assured.

    Product
    Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL Single Dose Vial, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1066-2013·2013-10-09

    AmeriSource Bergen Recalls Ifosfamide Injection Due to Temperature Abuse

    AmeriSource Bergen is recalling specific lots of Ifosfamide Injection because they were not refrigerated at certain distribution centers.

    Product
    Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4496-22
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1069-2013·2013-10-09

    Triangle Compounding Recalls Histamine Injectable Due to Sterility Concerns

    Triangle Compounding Pharmacy is recalling 8 vials of Histamine, 10 ng/mL Injectable due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.

    Product
    Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0006-2014·2013-10-09

    H&H Emergency Cricothyrotomy Kit Recall for Weakened Tubing

    H & H Associates is recalling 6,619 Emergency Cricothyrotomy Kits because the medical device tubing may become weakened and ineffective.

    Product
    H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2273-2013·2013-10-09

    CareFusion Recalls AVEA Ventilators for Barometric Pressure Error

    CareFusion is voluntarily correcting AVEA ventilators to fix a barometric pressure compensation error identified during a proactive review.

    Product
    Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66251-001·2013-10-09

    Watson Recalls Oxycodone and Acetaminophen Tablets Due to Foreign Contamination

    Watson Laboratories is recalling Oxycodone and Acetaminophen Tablets because foreign tablets were found in a sealed bottle.

    Product
    Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA, NDC 0591-0825-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1946-2013·2013-10-02

    Irene's Black & White Cookies Recalled for Undeclared Milk Allergen

    Irene's Bakery is recalling Black & White Cookies because they contain undeclared whey powder, a milk allergen, in the chocolate coating.

    Product
    Irene's Black & White Cookies, 8 oz. (226.4g) All Natural. Ingredients: Sugar, wheat flour, water, eggs, canola oil, unmodified food starch, corn syrup, vegetable fat, cocoa powder processed with alkali, mono and diglycerides, sea salt, sodium acid pyrophosphate, sodium…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1955-2013·2013-10-02

    Blythedale Farm Vermont Brie Recalled for Inadequate Pasteurization

    Blythedale Farm Inc. is recalling 11,678 units of Vermont Brie due to inadequate pasteurization. The product was distributed in 10 states and DC.

    Product
    Blythedale Farm Vermont Brie, 7 oz. wrapped disc in plastic cup UPC Code: 762713669010
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-1911-2013·2013-10-02

    Spartan Fresh Selections American Potato Salad Recalled for Listeria Risk

    Garden-Fresh Foods is recalling Spartan Fresh Selections American Potato Salad due to potential Listeria monocytogenes contamination.

    Product
    spartan fresh selections american potato salad, Net Wt. 16 oz (1 LB) 454g. UPC 11213-90320.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1949-2013·2013-10-02

    Mothers Milk Bank Recalls Pasteurized Human Breast Milk Due to Hepatitis B

    Mothers Milk Bank is recalling 70 bottles of pasteurized human breast milk because the donor tested reactive for Hepatitis B. The product was distributed to six hospitals in Honolulu and California.

    Product
    Human breast milk, pasteurized, 4 oz, in bottles; Pasteurized Human Milk,Hospital Grade Milk. Mother's Milk Bank 751 S. Bascom Abe.San Jose, CA 95128
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1063-2013·2013-10-02

    Walgreens Recalls Progesterone Injection Lot Due to Sterility Concerns

    Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate injection due to sterility assurance concerns with its testing laboratory.

    Product
    Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, Inject 1 mL Intramuscularly as directed by physician, Walgreens Specialty Pharmacy, Fresco, TX.
    Category
    Drug
    Distribution
    Distributed nationwide