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.

38401–38425 of 50506

  • HighCPSC·15173·2015-06-30

    Technosport Recalls Omersub Scuba Mask Due to Shattering Lens Hazard

    Technosport is recalling Omersub Zero Cube scuba masks because non-conforming glass lenses can shatter during normal use, posing an injury hazard.

    Product
    Omersub Zero Cube scuba diving mask
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V410000·2015-06-29

    Yamaha Recalls WR250X and WR250R Motorcycles Due to Stator Coil Defect

    Yamaha is recalling 2008-2015 WR250X and WR250R motorcycles because a stator coil defect may cause the battery to die and the engine to stall, increasing crash risk.

    Product
    YAMAHA — YAMAHA WR250X, WR250R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15172·2015-06-25

    Little Digger Toy Recalled Due to Excessive Lead in Red Paint

    Northern Tool + Equipment is recalling Little Digger Toys because the red paint contains excessive lead levels prohibited by federal law.

    Product
    Little Digger Toy
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1801-2015·2015-06-24

    Vidacare T.A.L.O.N Intraosseous Needle Recall for Potential Sterility Breach

    Vidacare Corporation is recalling T.A.L.O.N intraosseous needles due to a potential breach in sterility. The recall affects 2,104 boxes distributed in the US and internationally.

    Product
    T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1812-2015·2015-06-24

    Intuitive Surgical Recalls 5 mm Thoracic Grasper Due to Coating Damage

    Intuitive Surgical is recalling 2,436 units of 5 mm Thoracic Graspers because coating damage could cause fragments to fall into patients.

    Product
    Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems. Intended for endoscopic manipulation of tissue, including grasping.
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·15169·2015-06-24

    SR Suntour Bicycle Forks Recalled Due to Crash Hazard

    SR Suntour is recalling bicycles with specific fork models because a bolt can break, causing the front wheel to detach. This poses a crash hazard to riders.

    Product
    Bicycles with SR Suntour bicycle forks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1802-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Kits with Compromised Sterility

    Beaver-Visitec International is recalling 621 ophthalmic procedure kits because the included Devon Light Glove may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·15170·2015-06-24

    Positec Recalls Worx Electric Blower/Vacs Due to Shock Hazard

    Positec Tool Corp. is recalling Worx electric blower/vacs because reversed wiring poses a shock hazard. No injuries have been reported.

    Product
    Worx electric blower/vacs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1810-2015·2015-06-24

    Stryker Recalls Navigation System II-Cart Due to Weld Seam Defect

    Stryker is recalling 72 Navigation System II-Carts because a weld seam defect may cause the articulated arm joint to fail.

    Product
    Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1806-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Kits with Defective Devon Light Gloves

    Beaver-Visitec International Inc. is recalling 268 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584676 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2015·2015-06-24

    Smiths Medical Recalls CADD-Solis Pumps Due to Locking Assembly Binding

    Smiths Medical is recalling CADD-Solis Ambulatory Infusion Pumps because the locking assembly may bind, preventing the cassette or keypad from locking securely.

    Product
    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1804-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Kits with Compromised Sterility

    Beaver-Visitec International is recalling 585 ophthalmic procedure kits because the Devon Light Glove component may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1799-2015·2015-06-24

    Synthes Pull Reduction Device Recalled for Potential Intraoperative Breakage

    Synthes, Inc. is recalling Pull Reduction Devices for 4.3mm Percutaneous Drill Guides because incorrect hardness specifications may cause the devices to break during surgery.

    Product
    Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to the plate. This instrument can be used for: Minor Varus-valgus adjustments…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1815-2015·2015-06-24

    Integra Recalls Camino Intracranial Pressure Monitoring Catheters Due to Assembly Error

    Integra LifeSciences is recalling Camino Intracranial Pressure Monitoring Catheters because incorrect assembly may allow cerebrospinal fluid or blood to leak.

    Product
    Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring Catheter is a sterile transducer-tipped pressure monitoring catheter with accessory items to be used as a diagnostic tool for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1796-2015·2015-06-24

    Mortara ELI 380 Electrocardiograph Recalled for Patient Data Mismatch Risk

    Mortara Instrument is recalling 176 ELI 380 electrocardiographs because ECG waveforms may be incorrectly associated with the wrong patient's demographics when transmitted to records systems.

    Product
    ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored…
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1811-2015·2015-06-24

    CareFusion Alaris PC Unit Infusion Pump Software Recall

    CareFusion 303, Inc. is recalling 63 Alaris PC unit model 8015 infusion pumps due to a software defect that may allow infusions to start outside hospital-established limits.

    Product
    Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1693-2015·2015-06-24

    Neusoft NeuViz 64 CT Scanner Recalled for Teflon Compensator Failure

    Neusoft Medical System Co is recalling NeuViz 64 CT scanners because the Teflon A-plane compensator degrades under X-ray exposure, causing premature failure and image artifacts.

    Product
    Neusoft NeuViz 64 Multi-slice CT Scanner System
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1816-2015·2015-06-24

    BD Viper LT System Recalled for Potential False Positive Diagnostic Results

    Becton Dickinson is recalling seven BD Viper LT Systems due to the potential for false positive Chlamydia and Gonorrhea test results.

    Product
    BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1803-2015·2015-06-24

    Beaver-Visitec Recalls Ophthalmic Procedure Kits with Defective Gloves

    Beaver-Visitec is recalling 384 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.

    Product
    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1817-2015·2015-06-24

    Boston Scientific Recalls CLEARSIGN II Amplifiers Due to ECG Signal Interference

    Boston Scientific is recalling 43 CLEARSIGN II Amplifiers because blood pressure channel usage can cause ECG signals to become uninterpretable.

    Product
    CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: Material number: H30120020210 - 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; Material number…
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·15736·2015-06-24

    School Specialty Recalls NeoRok Stools Due to Fall Hazard

    School Specialty is recalling about 1,350 NeoRok stools because they can break during use, posing a fall hazard. No injuries have been reported.

    Product
    Classroom Select NeoRok Stools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1807-2015·2015-06-24

    Philips Q-Station Ultrasound Software Recalled for Data Integrity Issues

    Philips is recalling Q-Station ultrasound software because patient measurements may be incorrectly appended to other patients' studies.

    Product
    Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is…
    Category
    Medical Device
    Distribution
    Distributed nationwide