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.

37076–37100 of 50506

  • HighFDA (Devices)·Z-0344-2016·2015-12-09

    Stryker Recalls I.V. Poles Due to Unexpected Retraction Hazard

    Stryker is recalling 19,876 I.V. poles because a nonconforming latch housing may cause them to retract unexpectedly while holding medical equipment.

    Product
    Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. The I.V. poles are stationary, height adjustable stands intended to hold infusion liquids, infusion accessories, and/or other medical devices. They may be used on the following…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0444-2016·2015-12-09

    Western Drug Recalls Procaine HCl Injection Due to Sterility Concerns

    Western Drug is recalling Procaine HCl Injection 1% and 2% because the product lacks assurance of sterility. The recall covers all lots distributed nationwide.

    Product
    Procaine HCl Injection 1%, 2%, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·16054·2015-12-08

    TCP and Great Value LED Lamps Recalled for Electrical Shock Hazard

    Technical Consumer Products is recalling specific 14-watt LED PAR38 lamps sold at Walmart and electrical distributors due to a risk of electric shock in wet locations.

    Product
    Technical Consumer Products (TCP) and Great Value LED lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V824000·2015-12-08

    Audi Recalls 2015 A3 Cabriolet for Seat Cover Stitching Defect

    Volkswagen is recalling 904 2015 Audi A3 Cabriolets because incorrectly stitched seat covers may prevent side air bags from deploying properly in a crash.

    Product
    AUDI — AUDI A3 CABRIOLET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V819000·2015-12-07

    Tiny Idahomes Recalls RVs With Overheating Water Heater Valves

    Tiny Idahomes is recalling 2014-2016 RVs equipped with specific Atwood water heaters that may overheat water, posing a scalding risk.

    Product
    TINY IDAHOMES — TINY IDAHOMES CASCADE, CLEAR CREEK, CARPATHIAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V814000·2015-12-03

    ShowHauler Recalls One 2013 Motorhome Due to Water Heater Overheating

    ShowHauler Trucks is recalling one 2013 ShowHauler motorhome because a defective water heater valve may cause water to overheat, posing a scalding risk.

    Product
    SHOWHAULER — SHOWHAULER MOTORHOME
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0327-2016·2015-12-02

    NxStage System One S Cycler Recalled for Ultrafiltration Software Error

    NxStage Medical is recalling 16 System One S Cycler units due to a software error causing inaccurate fluid removal.

    Product
    NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0331-2016·2015-12-02

    Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect

    Covidien LLC is recalling 365 units of Palindrome Precision Chronic Catheter Kits because they were incorrectly packaged with a 90-degree bend at the distal tip.

    Product
    Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0225-2016·2015-12-02

    Frozen Cookie Dough Recalled for Undeclared Soy and Wheat

    Tower Cafe Inc. is recalling 480 tubs of Sugar Old Fashioned Gourmet Cookie Dough in Oklahoma due to undeclared soy and wheat allergens.

    Product
    Sugar Old Fashioned Gourmet Cookie Dough NET WT. 3 lb. (48 oz.) Distributed By: Tower Cafe, Okarche, OK 73762 packaged in plastic tub.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0340-2016·2015-12-02

    Siemens ADVIA Chemistry Hemoglobin A1c Reagent Kits Recalled for Bias

    Siemens Healthcare Diagnostics is recalling specific lots of ADVIA Chemistry Hemoglobin A1c reagent kits due to a positive bias that may result in inaccurate test results.

    Product
    ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood on the ADVIA Chemistry systems.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Drugs)·D-0386-2016·2015-12-02

    Qualgen Recalls Estradiol Pellets Due to Sterility Assurance Concerns

    Qualgen is recalling 4,221 vials of compounded Estradiol USP pellets nationwide because deficient practices may have impacted sterility assurance.

    Product
    Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01),12.5 mg (NDC 69761-012-01), 15 mg (NDC 69761-015-01),18 mg (NDC 69761-018-01),20 mg (NDC 69761-020-01), 22 mg (NDC 69761-022-01), 25 mg (NDC 69761-025-01)…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0336-2016·2015-12-02

    NxStage System One S Cycler Recalled for Ultrafiltration Software Error

    NxStage Medical is recalling 133 System One S Cycler units due to a software error that may cause the pump to continue removing fluid after the target volume is reached.

    Product
    NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0324-2016·2015-12-02

    Pega Medical Recalls SCFE Driver Instruments Due to Threaded Shaft Breakage

    Pega Medical Inc. is recalling 4 SCFE Driver instruments distributed in Florida and Tennessee because the threaded shaft broke during use.

    Product
    SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0288-2016·2015-12-02

    Skippy Creamy Peanut Butter Recalled for Potential Metal Shavings

    Hormel Foods is recalling 153 cases of Skippy Creamy 25% Less Fat Reduced Fat Peanut Butter Spread due to potential metal shavings in the jars.

    Product
    Skippy Creamy 25% Less Fat Reduced Fat Peanut Butter Spread Net Wt. 16.3 OZ (1 lb 0.3 OZ) 462g in plastic jars, UPC: 037600105002
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0320-2016·2015-12-02

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Software Issue

    Philips is recalling HeartStart MRx Monitor/Defibrillators because a software issue may cause the automated Ready-For-Use test to stop in an abnormal state when the device is turned off.

    Product
    Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0226-2016·2015-12-02

    Tower Cafe Oatmeal Raisin Cookie Dough Recalled for Undeclared Soy and Wheat

    Tower Cafe Inc. is recalling 596 tubs of Oatmeal Raisin Old Fashioned Gourmet Cookie Dough sold in Oklahoma due to undeclared soy and wheat allergens.

    Product
    Oatmeal Raisin Old Fashioned Gourmet Cookie Dough NET WT. 3 lb. (48 oz.) Distributed By: Tower Cafe, Okarche, OK 73762 packaged in plastic tub.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0326-2016·2015-12-02

    NxStage System One S Cycler Recalled for Ultrafiltration Software Error

    NxStage Medical is recalling 323 System One S Cycler units due to a software error that may cause inaccurate fluid removal during hemodialysis.

    Product
    NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0387-2016·2015-12-02

    Qualgen Recalls Testosterone Pellets Due to Sterility Assurance Concerns

    Qualgen is recalling 10,885 vials of compounded Testosterone USP pellets nationwide due to deficient practices that may impact sterility assurance.

    Product
    Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761-137-01), 50 mg (NDC 69761-150-01), 87.5 mg (NDC: 69761-187-01), 100 mg (NDC 69761-110-01), 200 mg (NDC 69761-120-01), Rx only, Compounded by Qualgen, Edmond…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0333-2016·2015-12-02

    Palindrome Precision Chronic Catheter Kit Recalled for Packaging Defect

    Covidien LLC is recalling 10 units of Palindrome Precision Chronic Catheter Kits due to incorrect packaging with a 90-degree bend at the distal tip.

    Product
    Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145061P The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be…
    Category
    Medical Device
    Distribution
    Distributed nationwide