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.

41151–41175 of 50511

  • HighFDA (Food)·F-1977-2014·2014-06-04

    Asian Bakery Recalls Cakes Due to Undeclared Wheat and Soy Lecithin

    Asian Bakery is recalling Bells cake and Round 8 cake due to undeclared wheat and soy lecithin. The products were sold in Portland, Oregon, and Vancouver, Washington.

    Product
    Bells cake; Round 8 cake packaged in plastic dome. Net Weight: 2lb 13oz. 1 unit/case; Asian Bakery Homemade Cakes and Pastries, 1233 SE 174th Ave, Portland OR 97233. No UPC code
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1658-2014·2014-06-04

    Siemens ADVIA Centaur Vitamin D Test Recalled for Fluorescein Interference

    Siemens Healthcare Diagnostics is recalling 40,266 ADVIA Centaur Systems VitD Total 100 test kits because samples containing fluorescein may interfere with the assay results.

    Product
    ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1350-2014·2014-06-04

    Sandoz Recalls Cefpodoxime Proxetil Tablets Due to Stainless Steel Particles

    Sandoz, Inc. is recalling Cefpodoxime Proxetil tablets because they contain stainless steel particles. The recall covers 22,818 bottles distributed nationwide.

    Product
    CEFPODOXIME PROXETIL — CEFPODOXIME PROXETIL (CEFPODOXIME PROXETIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1669-2014·2014-06-04

    Synthes ProDisc-C Milling Bits Recalled Due to Breakage Risk

    Synthes, Inc. is recalling specific lots of ProDisc-C 2.0mm Milling Bits because they have an increased potential to break during use.

    Product
    Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1976-2014·2014-06-04

    Asian Bakery Recalls Marquiz Cakes Due to Undeclared Allergens

    Asian Bakery is recalling Marquiz cakes due to undeclared milk, wheat, and soy lecithin. The cakes were sold in Portland, Oregon, and Vancouver, Washington.

    Product
    Marquiz cake; Round 8 cake packaged in plastic dome. Net Weight: 2lb 15.8 oz. 1 unit/case; Asian Bakery Homemade Cakes and Pastries, 1233 SE 174th Ave, Portland OR 97233. No UPC code
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1664-2014·2014-06-04

    Beaver-Visitec Anterior Chamber Cannula Recalled for Sharp Tip Needle

    Beaver-Visitec International Inc. is recalling Visitec Anterior Chamber Cannulas because some units contain a sharp tip needle instead of a blunt tip cannula.

    Product
    Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate. These products are used in all sections of the eye. This cannula…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1652-2014·2014-06-04

    Siemens Linear Accelerator Recall for Unvalidated Stereotactic Accessories

    Siemens Medical Solutions is recalling nine Linear Accelerator units because they may be used with unvalidated stereotactic accessories.

    Product
    Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1978-2014·2014-06-04

    Asian Bakery Recalls Velvet Cakes Due to Undeclared Wheat and Soy

    Asian Bakery is recalling round velvet cakes because they contain undeclared wheat and soy lecithin. The cakes were sold in Portland, Oregon, and Vancouver, Washington.

    Product
    Velvet cake; Round 8 cake packaged in plastic dome. Net Weight: 3lb 10oz. 1 unit/case; Asian Bakery Homemade Cakes and Pastries, 1233 SE 174th Ave, Portland OR 97233. No UPC code
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·14E035000·2014-06-02

    Roush Propane Fuel System Conversion Kits Recalled for Leak Risk

    Roush CleanTech is recalling propane fuel system conversion kits for Ford vans due to a potential leak at the fuel line fitting that could cause a fire.

    Product
    FUEL SYSTEM, OTHER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V292000·2014-06-02

    Jaguar Recalls 2013 XJ Vehicles Due to Airbag Software Defect

    Jaguar is recalling 2013 XJ vehicles because generic software in the Restraints Control Module may prevent the airbag system from operating correctly, increasing injury risk in a crash.

    Product
    JAGUAR — JAGUAR XJ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V282000·2014-05-29

    Mazda Recalls Tribute Vehicles for Steering Assist Software Defect

    Mazda is recalling 2008-2011 Tribute vehicles because a steering sensor may fail, causing the electric power steering assist to disengage.

    Product
    MAZDA — MAZDA TRIBUTE, TRIBUTE HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V283000·2014-05-29

    Peterbilt Trucks Recalled for Side Air Bag Warning Light Defect

    PACCAR is recalling 2010-2015 Peterbilt trucks because a blown fuse can disable the side air bag without triggering a warning light, increasing injury risk.

    Product
    PETERBILT — PETERBILT 388, 348, 384, 367
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V284000·2014-05-29

    Ford Recalls 2008-2011 Escape and Mercury Mariner for Steering Defect

    Ford is recalling 2008-2011 Escape and Mercury Mariner vehicles because the steering torque sensor may fail, causing loss of power steering assist.

    Product
    MERCURY — MERCURY, FORD MARINER, ESCAPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1643-2014·2014-05-28

    Gambro Polyflux Revaclear Dialyzers Recalled for Internal Blood Leaks

    Gambro Renal Products is recalling Polyflux Revaclear capillary dialyzers due to reports of internal blood leaks.

    Product
    Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1959-2014·2014-05-28

    Emparedados Boricua Pork, Ham, and Cheese Sandwich Recalled for Undeclared Soy

    Emparedados Boricua is recalling 780 units of Media Noche sandwiches in Puerto Rico due to undeclared soy from the Swiss cheese.

    Product
    "Emparedados Boricua, Media Noche (Pork, Ham and Cheese Sandwich), Net Wt. 7.6 oz (220g), Elaborated and Distributed by Emparedados Boricua, Bayamon, PR, 00956"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1624-2014·2014-05-28

    Hospira Recalls T-U-R Y-Sets Due to Potential Sterile Package Seal Defect

    Hospira is recalling specific T-U-R Y-Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.

    Product
    LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira Product Usage: For use in transurethral resection procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1958-2014·2014-05-28

    Emparedados Boricua Cubano Sandwiches Recalled for Undeclared Soy

    Emparedados Boricua is recalling 780 units of Cubano sandwiches in Puerto Rico due to undeclared soy from the cheese.

    Product
    "Emparedados Boricua, Cubano (Pork, Ham and Cheese Sandwich), net Wt. 7.6 oz (220 g), Elaborated and Distributed by Emparedados Boricua, Bayamon, PR, 00956"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1626-2014·2014-05-28

    Hospira Recalls Large Bore Y-Irrigation Sets Due to Packaging Seal Defect

    Hospira is recalling specific lots of Large Bore Y-Irrigation Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.

    Product
    LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira Product Usage: For Use With Flexible Irrigation Container Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1640-2014·2014-05-28

    GE Healthcare Recalls NeuroMuscular Transmission Modules for Inaccurate Readings

    GE Healthcare is recalling 1,794 NeuroMuscular Transmission Modules because they may display inaccurate muscle relaxation levels when used with ElectroSensors.

    Product
    GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1960-2014·2014-05-28

    Emparedados Boricua Tripleta Sandwiches Recalled for Undeclared Soy

    Emparedados Boricua is recalling Tripleta sandwiches in Puerto Rico due to undeclared soy from the cheese ingredient.

    Product
    "Emparedados Boricua, Tripleta (Turkey Pastrami, Turkey, Ham and Cheese Sandwich), Net Wt. 8 oz. (230g), Elaborated and Distributed by Emparedados Boricua, Bayamon, PR, 00956"
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1646-2014·2014-05-28

    Philips XIRIS 8.1.50.0 Recall Due to Patient Data Synchronization Error

    Philips Healthcare Informatics is recalling 5 units of XIRIS 8.1.50.0 due to a synchronization error that may display incorrect patient information.

    Product
    Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling…
    Category
    Medical Device
    Distribution
    2 states
  • HighNHTSA·14V302000·2014-05-28

    Champion Bus Defender Recall for Defective Seat Belt Buckles

    Champion Bus is recalling 2014 Defender shuttle buses because seat belt buckles may fail to release, hindering emergency egress.

    Product
    CHAMPION BUS — CHAMPION BUS DEFENDER
    Category
    Vehicle
    Distribution
    Distributed nationwide