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.

42426–42450 of 50511

  • HighFDA (Food)·F-0189-2014·2013-11-27

    American Beverage Corp. Recalls Big Hug Fruit Barrel Orange Bottles

    American Beverage Corp. is recalling Big Hug Fruit Barrel Orange bottles due to a potential risk of nozzle cap parts becoming dislodged and ingested.

    Product
    Big Hug, Fruit Barrel Orange in a plastic 16 oz bottle with a sports cap, American Beverage Corp., Verona, PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0341-2014·2013-11-27

    Synthes Soft Tissue Retractor Recalled for Potential Nut Breakage

    Synthes USA HQ, Inc. is recalling 374 Soft Tissue Retractors because the locking screw nut may break if overtightened.

    Product
    Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0373-2014·2013-11-27

    GE Vivid E9 Ultrasound Systems Recalled for Software Lockup

    GE Healthcare is recalling 710 Vivid E9 ultrasound systems worldwide due to a software defect that can cause the system to slow down and lock up during critical procedures.

    Product
    GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0363-2014·2013-11-27

    Stryker Rose Bed Siderail Latch Failure Recall

    Stryker is recalling Model FL14E Rose Beds because siderails may appear latched when they are not, posing a risk of patient injury.

    Product
    Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with a built-in motor and controls that can be operated to adjust the height and surface contour of the bed. The device includes movable and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0367-2014·2013-11-27

    GE Healthcare Recalls SPECT Imaging Systems Due to Potential Patient Contact Hazard

    GE Healthcare is recalling four models of nuclear medicine and CT imaging systems because the detector may contact a patient's elbow during specific SPECT scans.

    Product
    GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0211-2014·2013-11-27

    American Beverage Corp. Recalls Big Burst Fruit Punch Drink Due to Cap Hazard

    American Beverage Corp. is recalling Big Burst Fruit Punch Drink because the sports cap nozzle may dislodge and be ingested, posing a health hazard.

    Product
    Big Burst Fruit Punch Drink, in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0194-2014·2013-11-27

    Guzzler Kiwi-Strawberry Beverage Recalled for Potential Cap Fragment Ingestion

    American Beverage Corp is recalling Guzzler Kiwi-Strawberry beverages because a part of the nozzle cap may dislodge and be ingested.

    Product
    Guzzler Kiwi-Strawberry, 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0208-2014·2013-11-27

    American Beverage Corp. Recalls Big Hug Fruit Barrel Blue Raspberry Bottles

    American Beverage Corp. is recalling Big Hug Fruit Barrel Blue Raspberry bottles due to a potential choking hazard from the sports cap.

    Product
    Big Hug Fruit Barrel Blue Raspberry in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0371-2014·2013-11-27

    FDA Recalls Medcare Max-500 Patient Stands Due to Load Failure Risk

    Ergosafe Products LLC is recalling 233 Medcare Max-500 patient stands because the lift mechanism might fail under the labeled 500-lb load rating.

    Product
    Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0206-2014·2013-11-27

    Big Hug Lemonade Fruit Drink Recalled for Potential Cap Fragment Ingestion

    American Beverage Corp is recalling Big Hug Lemonade Fruit Drink because a part of the nozzle cap could become dislodged and ingested, posing a health hazard.

    Product
    Big Hug Lemonade Fruit Drink in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0214-2014·2013-11-27

    American Beverage Corp. Recalls Big Burst Citrus Punch Drink Bottles

    American Beverage Corp. is recalling Big Burst Citrus Punch Drink bottles due to a potential choking hazard from the sports cap nozzle.

    Product
    Big Burst Citrus Punch Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0335-2014·2013-11-27

    Philips Brilliance iCT CT Scanner Recall for Footrest Contact Hazard

    Philips is recalling nine Brilliance iCT CT scanners because the footrest extension can contact the gantry or user during operation.

    Product
    Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0207-2014·2013-11-27

    Big Hug Lemon Lime Fruit Drink Recalled for Potential Cap Ingestion Hazard

    American Beverage Corp. is recalling Big Hug Lemon Lime Fruit Drink bottles due to a risk that nozzle cap parts could be ingested after excessive chewing.

    Product
    Big Hug Lemon Lime Fruit Drink in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0330-2014·2013-11-27

    GE Centricity Laboratory Software Recalled for Panel Reflex Failure

    GE Healthcare is recalling Centricity Laboratory System software versions 3.3, 4.0, and 4.1 because panel reflexing may fail under specific conditions.

    Product
    The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0212-2014·2013-11-27

    American Beverage Corp. Recalls Big Burst Blue Raspberry Drink Due to Cap Hazard

    American Beverage Corp. is recalling Big Burst Blue Raspberry Drink because the sports cap nozzle may dislodge and be ingested if chewed excessively.

    Product
    Big Burst Blue Raspberry Drink in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0181-2014·2013-11-27

    Kerry Foods Recalls Idahoan Steakhouse Parmesan Topping Due to Salmonella Risk

    Kerry Foods is recalling Idahoan Steakhouse Parmesan topping because it was produced on equipment that processed a product testing positive for Salmonella.

    Product
    Idahoan, Steakhouse Parmesan topping, Net Weight 35 lbs., Item Code ZID800Bulk.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0205-2014·2013-11-27

    American Beverage Corp. Recalls Big Hug Fruit Barrel Kiwi Strawberry Bottles

    American Beverage Corp. is recalling Big Hug Fruit Barrel Kiwi Strawberry bottles due to a potential choking hazard from dislodged nozzle cap parts.

    Product
    Big Hug Fruit Barrel Kiwi Strawberry, in a 16 oz plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0190-2014·2013-11-27

    Guzzler Lemonade Recalled for Potential Ingestion of Dislodged Bottle Cap Parts

    American Beverage Corp is recalling Guzzler Lemonade 20 fl. oz. bottles due to a risk that nozzle cap parts may dislodge and be ingested.

    Product
    Guzzler Lemonade 20 fl. oz. PET plastic bottle with a sports cap, American Beverage Corporation, Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0329-2014·2013-11-27

    Olympus Endoscopic Flushing Pump Recalled for Potential Standby Mode Failure

    Olympus America Inc. is recalling 263 Endoscopic Flushing Pumps because the pump head may not be locked, potentially causing the device to stop and enter power stand-by mode during procedures.

    Product
    Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0305-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry CK Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry CK Slides due to slide dispense issues. The recall affects 86,503 units distributed worldwide.

    Product
    VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 8478034 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2014·2013-11-27

    Siemens ADVIA Chemistry System Software Recalled for Flagging Errors

    Siemens Healthcare Diagnostics is recalling ADVIA 1650 system software due to incorrect ration parameter flagging behavior.

    Product
    ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0210-2014·2013-11-27

    American Beverage Corp. Recalls Big Burst Lemon Lime Drink Bottles

    American Beverage Corp. is recalling Big Burst Lemon Lime Drink bottles due to a potential choking hazard from dislodged nozzle cap parts.

    Product
    Big Burst Lemon Lime Drink, in a 16 oz PET plastic bottle with a sports cap, American Beverage Corp., Verona PA.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0351-2014·2013-11-27

    Spacelabs qube Patient Monitor Recalled for Power-On Failure

    Spacelabs Healthcare is recalling 54 qube Compact Patient Monitors because an incorrect microcontroller may prevent the device from powering on.

    Product
    Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0340-2014·2013-11-27

    Stryker Recalls Reprocessed Diagnostic Electrophysiology Catheters and Cables

    Stryker Sustainability Solutions is recalling 46 reprocessed diagnostic electrophysiology catheters and cables due to a potential sterility breach in the package seal.

    Product
    Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 401977, 401981, 401982, C6-MR/MST4-SA, CB3434CT. Product Usage: Reprocessed…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-0188-2014·2013-11-27

    American Beverage Corp. Recalls Big Burst Orange Drink Due to Cap Hazard

    American Beverage Corp. is recalling Big Burst Orange Drink in 16 oz PET bottles because the nozzle cap may dislodge and be ingested.

    Product
    Big Burst Orange Drink in a 16 oz PET bottle with a sports cap, American Beverage Corp., Verona, PA.
    Category
    Food
    Distribution
    Distributed nationwide