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.

28476–28500 of 50488

  • HighFDA (Devices)·Z-2256-2018·2018-06-27

    Pentax C2 CryoBalloon Focal Catheter Recalled for Connector Alignment Defect

    Pentax of America Inc is recalling 57 units of the C2 CryoBalloon Focal Catheter because a misaligned arrow may allow the catheter to detach from the controller during use.

    Product
    C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2247-2018·2018-06-27

    Synthes Graphic Case F/7.3mm Cannulated Screw Set Recalled for Measurement Error

    Synthes (USA) Products LLC is recalling three units of the Graphic Case F/7.3mm Cannulated Screw Set because the included gauges measure screws 5.41mm shorter than their actual length.

    Product
    Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2248-2018·2018-06-27

    Siemens Biograph mCT Systems Recalled Due to Falling Laser Cover Windows

    Siemens Medical Solutions is recalling 405 Biograph mCT systems because laser cover windows may fall off, posing a potential hazard.

    Product
    Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2246-2018·2018-06-27

    Synthes Graphic Case F/6.5mm Cannulated Screw Set Recalled for Measurement Error

    Synthes (USA) Products LLC is recalling four units of the Graphic Case F/6.5mm Cannulated Screw Set because the screw gauges measure 5.41mm shorter than the actual screw length.

    Product
    Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2262-2018·2018-06-27

    TriMed Recalls Nitinol Staples Due to Missing Sterilization Audit Records

    TriMed Inc. is recalling 532 Nitinol staples because quarterly sterilization dose audit records could not be found, posing a risk of patient infection.

    Product
    Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2266-2018·2018-06-27

    Datex-Ohmeda CARESCAPE R860 Ventilators Recalled for Display Processor Failure

    Datex-Ohmeda is recalling CARESCAPE R860 ventilators with software version 10SP05 because the display processor may experience unexpected failure.

    Product
    CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2231-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2233-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling specific trauma guide wires because packaging defects may allow sterile barrier breaches, creating a potential risk of infection.

    Product
    BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2018·2018-06-27

    TriMed Nitinol Staple Recall Due to Missing Sterilization Audit Records

    TriMed Inc. is recalling 1,194 Nitinol staples because evidence of required quarterly sterilization dose audits could not be found, posing a potential infection risk.

    Product
    Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2237-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling 832 trauma guide wires because packaging defects may compromise sterility, posing a risk of infection.

    Product
    G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2018·2018-06-27

    Cyberonics VNS Therapy Programmer Model 3000 Recalled for Parameter Miscalculation

    Cyberonics is recalling 252 VNS Therapy Programmer Model 3000 units because certain programming events can miscalculate parameters for implanted generators, potentially causing painful stimulation or lack of therapy.

    Product
    VNS Therapy Programmer, Model 3000, v1.0 System
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-2230-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2239-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Packaging Defects

    Zimmer Biomet is recalling trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2236-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling 361 trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    G-PIN 2.8BL 3.2PL 60CM 2PK; 467265 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2241-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling 248 trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2264-2018·2018-06-27

    TriMed Recalls Nitinol Surgical Staples Due to Sterilization Record Gaps

    TriMed Inc. is recalling 706 units of Nitinol Surgical Staples because quarterly sterilization dose audits could not be verified, posing a potential infection risk.

    Product
    Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2240-2018·2018-06-27

    Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure

    Zimmer Biomet is recalling 304 trauma guide wires because packaging defects may allow sterile barrier breaches, posing a risk of infection.

    Product
    3.2MM X 510MM COCR THD TIP; 14-443053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·18181·2018-06-26

    Huish Outdoors Recalls Scuba Diving Regulators Due to Drowning Hazard

    Huish Outdoors is recalling Oceanic and Hollis scuba diving regulators because they can restrict airflow at low tank pressures, posing a drowning hazard to divers.

    Product
    Oceanic and Hollis scuba diving regulators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V429000·2018-06-25

    Keystone Recalls 2019 Summerland Trailers Due to Incorrect Tire Label

    Keystone is recalling 2019 Summerland recreational trailers because the Federal Identification Label lists an incorrect tire rim size, which could lead to improper rim replacement.

    Product
    KEYSTONE — KEYSTONE SUMMERLAND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V424000·2018-06-25

    Spartan Emergency Vehicles Recalled for Fire Pump Solenoid Corrosion

    Spartan Motors is recalling 2009-2018 Gladiator and MetroStar emergency vehicles because internal corrosion in the fire water pump solenoid may cause loss of water pressure, increasing injury risk.

    Product
    SPARTAN — SPARTAN METROSTAR, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide