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.

42151–42175 of 50511

  • HighFDA (Devices)·Z-0607-2014·2014-01-08

    Baxter IntelliFill Pharmacy Compounding Device Recalled for Filtration Defect

    Baxter Healthcare is recalling 28 IntelliFill i.v. Pharmacy Compounding Devices because they may operate with HEPA filtration disabled.

    Product
    IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2014·2014-01-08

    Zimmer Recalls ITST Threaded Guide Pins Due to Sterility Concerns

    Zimmer, Inc. is recalling ITST Threaded Guide Pins because testing found that a specific packaging tray configuration failed to maintain sterile barrier integrity.

    Product
    ITST THREADED GUIDE PIN
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0595-2014·2014-01-08

    Asante Comfort Infusion Set Recalled for Tubing Disconnection and Insulin Leakage

    Asante Solutions is recalling 246 Comfort Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and reduced delivery to patients.

    Product
    Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1261-2014·2014-01-08

    Mira Health Recalls Nature Science ADT Capsules Due to Contamination Risk

    Mira Health Products Ltd. is recalling Nature Science ADT capsules because they may contain undeclared steroids or chemical additives due to poor manufacturing practices.

    Product
    Nature Science ADT capsules, packaged as a bulk product in clear plastic bags.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1340-2014·2014-01-08

    Wegman's New England Clam Chowder Recalled for Undeclared Crab

    Blount Fine Foods is recalling Wegman's New England Clam Chowder because it may contain undeclared crab, a shellfish allergen.

    Product
    Wegman's Brand New England Clam Chowder (refrigerated at 38F or below) in a 16 oz plastic cup.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0584-2014·2014-01-08

    Philips Essenta DR X-ray System C-arm Casting Recall

    Philips is recalling 424 Essenta DR stationary X-ray systems because the C-arm casting may loosen and fall.

    Product
    Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0613-2014·2014-01-08

    Philips HeartStart MRx Defibrillators Recalled for Potential Shutdown

    Philips is recalling HeartStart MRx monitor/defibrillators because they may shut down without warning if exposed to elevated electromagnetic interference.

    Product
    Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1316-2014·2014-01-08

    Mira Health Products Recalls Biogenix USA Bolasterol Capsules

    Mira Health Products Ltd. is recalling Biogenix USA Bolasterol capsules due to potential contamination with undeclared steroids, pharmaceutical ingredients, or chemical additives.

    Product
    Biogenix USA Bolasterol capsules, packaged as a bulk product in clear plastic bags.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0602-2014·2014-01-08

    Integra Camino Advanced Monitor Recalled for Reversed Pressure Display

    Integra LifeSciences is recalling 275 Camino Advanced Monitors because a firmware error may display reversed systolic and diastolic intracranial pressure values.

    Product
    Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 series of Pressure / Temperature and Pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0601-2014·2014-01-08

    Asante Conset Infusion Set Recalled for Tubing Disconnects

    Asante Solutions is recalling 1,085 Conset Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and under-dosing.

    Product
    Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1329-2014·2014-01-08

    Biogenix USA HAM capsules recalled for potential undeclared steroids

    Mira Health Products Ltd. is recalling Biogenix USA HAM capsules due to potential contamination with undeclared steroids and chemical additives.

    Product
    Biogenix USA HAM capsules, packaged as a bulk product in clear plastic bags.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1312-2014·2014-01-08

    Mira Health Recalls Biogenix USA Formex Capsules Due to Contamination Risk

    Mira Health Products Ltd. is recalling Biogenix USA Formex capsules because they may contain undeclared steroids or chemical additives due to poor manufacturing practices.

    Product
    Biogenix USA Formex capsules, packaged as a bulk product in clear plastic bags.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1339-2014·2014-01-08

    Down Unders Cookie Mobile Meal Recalled for Allergen Labeling Error

    Cuisine Med. Catering is recalling Down Unders Cookie Mobile Meals because the label incorrectly states 'NO NUTS' while listing coconut in the ingredients.

    Product
    Down Unders Cookie Mobile Meal sold under brand Down Unders, approximately 6.75 oz. (189 gram).
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1270-2014·2014-01-08

    Mira Health Recalls Halostane Capsules Due to Potential Steroid Contamination

    Mira Health Products Ltd. is recalling Nature Science Halostane capsules due to potential contamination with undeclared steroids and pharmaceutical ingredients.

    Product
    Nature Science Halostane capsules packaged as a bulk product in clear plastic bags.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0600-2014·2014-01-08

    Asante Conset Infusion Set Recalled for Tubing Disconnects

    Asante Solutions is recalling Conset Infusion Sets because tubing may disconnect from the connector, causing insulin leakage and reduced delivery.

    Product
    Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0599-2014·2014-01-08

    Asante Conset Infusion Set Recalled for Tubing Disconnection and Insulin Leakage

    Asante Solutions is recalling Conset Infusion Sets because the tubing may disconnect from the connector, causing insulin leakage and delivering less insulin than intended.

    Product
    Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2014·2014-01-08

    Stryker S3 Med/Surg Bed Recall for Foot End Cover Damage

    Stryker is recalling S3 Med/Surg beds due to potential damage to the Foot End Cover and Power Coil Cable caused by reduced clearance.

    Product
    S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0559-2014·2014-01-01

    B. Braun IV Catheters Recalled for Missing Safety Clip

    B. Braun Medical is recalling 55,200 Introcan Safety IV Catheters because one lot may lack the anti-needlestick safety clip.

    Product
    B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or…
    Category
    Medical Device
    Distribution
    Distributed nationwide