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.

42526–42550 of 50511

  • HighFDA (Devices)·Z-0286-2014·2013-11-20

    Hospira Recalls Plum A+3 Infusion Systems Due to Broken Pressure Sensor Pin

    Hospira is recalling 214 Plum A+3 Infusion Systems because a pressure sensor pin may break, potentially preventing the detection of line occlusions.

    Product
    The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0164-2014·2013-11-20

    Apotheca Energique Gastrozyme Recalled for Potential Chloramphenicol Contamination

    Grato Inc. is recalling Apotheca Energique Gastrozyme dietary supplements because they may contain chloramphenicol. The product was sold nationwide through retail and internet channels.

    Product
    Apotheca Energique Gastrozyme, dietary supplement, 100 vegetarian capsules.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2014·2013-11-20

    Baxter Recalls SIGMA SPECTRUM Infusion Pumps Due to Alarm Issues

    Baxter Healthcare is recalling SIGMA SPECTRUM Infusion Pumps because they may trigger false upstream occlusion or air-in-line alarms during use.

    Product
    SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0208-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Pumps Due to Pressure Sensor Drift

    Hospira is recalling 7,691 Plum A+ Infusion Pumps because pressure sensor calibration drift may cause false alarms or undetected occlusions.

    Product
    Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0279-2014·2013-11-20

    Medtronic Activa Neurostimulators Recalled for Loss of Stimulation

    Medtronic is recalling specific Activa rechargeable neurostimulators because they may lose stimulation when switching programs. Therapy can be restored using the Physician Recharge mode.

    Product
    Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2014·2013-11-20

    Terumo Recalls Sarns Soft-Flow Aortic Cannulas Due to Particulate

    Terumo is recalling 30 units of Sarns Soft-Flow Aortic Cannulas because loose fiber particulate was found during inspection.

    Product
    Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with 3/8" connector, 14" (36 cm) long. Indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0285-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Systems Due to Broken Sensor Pin Risk

    Hospira is recalling 71 Plum A+ Infusion Systems because a pressure sensor pin may break, potentially preventing the detection of line occlusions.

    Product
    The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0161-2014·2013-11-20

    Klaire Labs Interfase Enzyme Supplement Recalled for Chloramphenicol Contamination

    ProThera, Inc. is recalling Klaire Labs Interfase enzyme supplements because the enzymes used may be contaminated with chloramphenicol.

    Product
    Klaire Labs Interfase; Enzyme Supplement; Packaged in 60 and 120 Vegetarian capsules bottles. UPC 60 ct.- 7 0961 012270 7; UPc 120 ct. - 7 09616-01229 1 Manufactured by ProThera, Inc., , Klaire Labs is a division of ProThera Reno, NV 89521
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0269-2014·2013-11-20

    Philips IntelliSpace PACS 4.4 Software Recall for Image Storage Defect

    Philips is recalling IntelliSpace PACS 4.4 software due to a timing issue that may prevent the system from storing additional images, potentially affecting clinical diagnoses.

    Product
    Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0170-2014·2013-11-20

    Oh Bok Bakery Recalls Sweet Bread for Undeclared Wheat Flour

    Cho & So, Inc. DBA Oh Bok Bakery is recalling ASSI brand Sweet Bread (Bam Bbang) because wheat flour was not declared on the label.

    Product
    Sweet Bread known as Bam Bbang (Chestnut Bread) packed on styrofoam tray with plastic over wrap ASSI brand Korean Cake 20646D Net Wt.: 8 oz. Distributed by Rhee Bros., Inc. 7461 Coca Cola Dr Hanover, MD 21076 Expiration date 1/29/14 With Korean language labeling
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0191-2014·2013-11-20

    DePuy Mitek FMS Intermediary Tubing Recalled Due to Valve Malfunction

    DePuy Mitek is recalling FMS Intermediary Tubing with One-Way Valve because the pillow valve may not perform as intended, potentially leading to patient cross-contamination.

    Product
    DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Systems connects the Inflow Tubing to the arthroscopic sheath during arthroscopic procedures. The Polyvinyl Chloride (PVC) tubing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0283-2014·2013-11-20

    Hospira Recalls Plum A+ Infusers Due to Broken Pressure Sensor Pin

    Hospira Inc. is recalling 179 Plum A+ Hyperbaric Infusion Systems because the distal pressure sensor pin may break, potentially preventing the detection of line occlusions.

    Product
    The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Hyperbaric Infusion System is designed to deliver parenteral, enteral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0287-2014·2013-11-20

    Hospira Recalls Plum A+ Infusion Systems Due to Broken Sensor Pin Risk

    Hospira Inc. is recalling 182,971 Plum A+ Infusion Systems because a distal pressure sensor pin may break, potentially preventing the detection of line occlusions.

    Product
    The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0288-2014·2013-11-20

    Hospira Recalls Plum A+3 Infusion Systems Due to Broken Sensor Pin Risk

    Hospira is recalling 7,692 Plum A+3 Infusion Systems because a pressure sensor pin may break, potentially preventing the detection of line occlusions.

    Product
    The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+3 Infusion System is designed to deliver parenteral, enteral, or epidural…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V649000·2013-11-19

    Cruiser RV Recalls Trailers Due to Door Lock Jamming Hazard

    Cruiser RV is recalling 2006-2013 recreational trailers because a door lock defect may jam the deadbolt, potentially trapping occupants inside the vehicle.

    Product
    CRUISER RV — CRUISER RV RADIANCE, VIEWFINDER, SIGNATURE, ENTERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V574000·2013-11-19

    Spartan Recalls 2013-2014 Utilimaster P80X Vehicles for Defrost Hose Issue

    Spartan Motors is recalling 586 Utilimaster P80X vehicles sold to UPS because a kinked coolant hose may prevent the windshield defrost system from working, reducing visibility.

    Product
    UTILIMASTER — UTILIMASTER P80X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V575000·2013-11-19

    Space Craft Recalls Fifth Wheel Trailers Due to Door Lock Defect

    Space Craft is recalling 2006-2013 fifth wheel and travel trailers equipped with Fastec door locks that may jam, potentially trapping occupants inside.

    Product
    SPACE CRAFT — SPACE CRAFT FIFTH WHEEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14020·2013-11-15

    Step2 Recalls Ride-On Wagon Toys Due to Fall Hazard

    Step2 is recalling about 14,000 Whisper Ride Touring Wagons because removable seat backs can detach, allowing children to fall out.

    Product
    Step2® Whisper Ride Touring Wagon™
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V568000·2013-11-14

    Volkswagen Recalls 2013-2014 Jetta Hybrid Vehicles for Gearbox Corrosion

    Volkswagen is recalling 2013-2014 Jetta Hybrid vehicles because gearbox corrosion may cause an electrical short and sudden loss of power, increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN JETTA HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays Due to Visual Particulates

    Smiths Medical is recalling Portex Spinal Anaesthesia Trays because visual particulates were found in the included Lidocaine and Dextrose ampules.

    Product
    Portex¿ Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0138-2014·2013-11-13

    Elekta Recalls Stereotactic Circular Collimators Due to Potential Clinical Errors

    Elekta, Inc. is recalling 89 Stereotactic Circular Collimators used in radiotherapy for head tumors due to a potential for clinical errors.

    Product
    Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0124-2014·2013-11-13

    Safeway Recalls Angel Food Cups Due to Missing Milk and Soy Allergen Labels

    Safeway is recalling 448 packages of Angel Food Cups because the labels failed to list milk and soy as ingredients.

    Product
    Angel Food Cups 4 Count; labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Angel Food Cups 4 Count  0 lb. 3 oz. (85g); Individual cake cups sold in package of 4 items.
    Category
    Food
    Distribution
    21 states