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.

36801–36825 of 50507

  • HighFDA (Drugs)·D-0573-2016·2016-01-27

    Freedom Pharmaceuticals Recalls Baclofen Powder Due to Foreign Substance

    Freedom Pharmaceuticals is recalling specific lots of Baclofen USP powder because of the presence of a foreign substance.

    Product
    Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm (120 oz container, Rx only, 801 W New Orleans St. Broken Arrow, OK 74011. NDC: (a) 52372-0909-25; (b) 52372-0909-01; (c) 52372-0909-50; (d)…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0670-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Large Torso Wrap Due to Overheating Risk

    MWT Materials, Inc. is recalling five units of Accusorb MRI Large Torso Wraps because they may overheat when not used correctly, posing a risk of patient injury.

    Product
    Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0681-2016·2016-01-27

    GE Healthcare Anesthesia Systems Recalled for Potential Barotrauma Risk

    GE Medical Systems is recalling certain Aisys and Avance anesthesia systems because a stuck valve could cause excessive pressure in the patient breathing circuit, potentially leading to barotrauma.

    Product
    GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult).…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V038000·2016-01-26

    New Flyer and NABI Buses Recalled for Seat Belt Anchor Defect

    New Flyer is recalling specific 2009-2015 New Flyer and NABI buses because missing welds on seat brackets could allow seat belts to separate during a crash.

    Product
    NEW FLYER — NEW FLYER, NABI MD30, XN60, XN35, XDE35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V039000·2016-01-26

    ShowHauler Recalls 2007-2011 Motorhomes Due to Unstable Entry Steps

    ShowHauler is recalling 2007-2011 motorhomes, garage coaches, and toter coaches because electric entry steps may become unstable, increasing injury risk.

    Product
    SHOWHAULER — SHOWHAULER MOTORHOME, GARAGE COACH, TOTER COACH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V031000·2016-01-22

    Collins Recalls 2015 School Buses Due to Peeling Stop Arm Decals

    Collins is recalling 867 model year 2015 school buses because reflective decals on the stop arms may peel off, reducing visibility to other drivers.

    Product
    COLLINS — COLLINS DE500, DE416, DE516, DE516WR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V033000·2016-01-22

    Vintage Trailers Recall Triple Axle Models Due to Incorrect Weight Labeling

    Vintage Trailers is recalling 2009-2016 triple axle trailers because the Federal Certification Label incorrectly lists the gross axle weight rating, potentially leading to axle failure if overloaded.

    Product
    VINTAGE — VINTAGE BANDIT, AERO, OUTLAW, INTIMIDATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16081·2016-01-21

    Britax Recalls B-Safe 35 Infant Car Seats Due to Handle Crack Hazard

    Britax is recalling about 71,000 B-Safe 35 infant car seats because the carry handle can crack and break, posing a fall hazard to infants.

    Product
    Britax B-Safe 35 and B-Safe 35 Elite infant car seats and travel systems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16723·2016-01-21

    Chillafish Recalls Children's Balance Bikes Due to Laceration Hazard

    Chillafish is recalling BMXie, Jack, and Josie balance bikes because overinflated tires can cause plastic rims to crack and send pieces flying, posing a laceration hazard.

    Product
    Children's bikes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0644-2016·2016-01-20

    CompView NuCARTGN Medical Display Recall Due to Spring Arm Detachment Risk

    CompView Medical is recalling 10 NuCARTGN mobile display units because the spring arm may detach if the securing ring was not installed correctly.

    Product
    Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signals from source devices to flat-panel monitors. It is tailored for use with an OEC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V023000·2016-01-20

    Altec Recalls Aerial Devices Due to Hydraulic Valve Defect

    Altec is recalling 2010-2015 AH75, AH85, and AH100 aerial devices because a hydraulic valve may allow unexpected movement, increasing injury risk.

    Product
    ALTEC — ALTEC AH75, AH85, AH100
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0625-2016·2016-01-20

    Zimmer Biomet Recalls Virage OCT Spinal Fixation System Due to Set Screw Defect

    Zimmer Biomet is recalling the Virage OCT Spinal Fixation System because set screw staking is out of specification, which can interfere with rod insertion.

    Product
    Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952
    Category
    Medical Device
    Distribution
    20 states
  • HighCPSC·16079·2016-01-20

    Cheryl's Jingle Bell Ornaments Recalled for Sharp Metal Edges

    Cheryl & Co. is recalling Jingle Bell ornaments sold by QVC because sharp metal edges on the cutouts pose a laceration hazard.

    Product
    Cheryl's Jingle Bell ornaments with cookies and confections
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0507-2016·2016-01-20

    Nestle Recalls Sweet Leaf Organic Tea Mint & Honey Due to Glass Particles

    Nestle Waters North America is recalling Sweet Leaf Organic Tea Mint & Honey because the product contains glass particles.

    Product
    Sweet Leaf Organic Tea Mint & Honey, 16 oz glass bottle UPC: 6-51538-06701-2
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0622-2016·2016-01-20

    OrthoPediatrics Recalls Response Spine Pedicle Screws Due to Manufacturing Defect

    OrthoPediatrics Corp is recalling 102 Response Spine UniAxial Pedicle Screws because they may have been manufactured incorrectly, preventing the driver from fully engaging the screw.

    Product
    UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative…
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Food)·F-0485-2016·2016-01-20

    Garden Harvest Recalls House MADE Sriracha Sauce for Unlicensed Manufacturing

    Garden Harvest is recalling House MADE Sriracha Sauce because the firm was manufacturing acidified foods without a license.

    Product
    House MADE Sriracha Sauce NET WT. 8 oz (237 mL) INGREDIENTS: THAI CHILIES, DISTILLED VINEGAR, SUGARS, GARLIC, MOLASSES, KOSHER SALT. www.housemadesriracha.com UPC 6 12524 99999 1
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0506-2016·2016-01-20

    Nestle Recalls Sweet Leaf Peach Iced Tea Due to Glass Particles

    Nestle Waters North America is recalling Sweet Leaf All Natural Peach Iced Tea because the product contains glass particles.

    Product
    Sweet Leaf All Natural Peach Iced Tea , 16 oz glass bottle UPC: 6-51538-06704-3
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0648-2016·2016-01-20

    Brainlab RT Elements software recall for image cropping defect

    Brainlab AG is recalling RT Elements software because large objects may display cropped during import, potentially affecting radiation treatment planning.

    Product
    RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0640-2016·2016-01-20

    Ortho-Clinical VITROS 3600 Chemistry System Recalled for Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 3600 Chemistry Systems due to a software anomaly that may allow the device to process assays at incorrect temperatures, potentially producing erroneous results.

    Product
    VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a…
    Category
    Medical Device
    Distribution
    Distributed nationwide