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.

37426–37450 of 50506

  • HighCPSC·16008·2015-10-15

    Horizon Hobby Recalls E-flite Battery Chargers Due to Fire Hazard

    Horizon Hobby is recalling E-flite Ultra Micro-4 AC/DC Battery Chargers because they can overheat and cause fires. No injuries have been reported.

    Product
    E-flite Ultra Micro-4 AC/DC Battery Chargers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V660000·2015-10-15

    BMW Recalls 2002-2005 MINI Cooper Vehicles for Steering Assist Loss

    BMW is recalling 2002-2005 MINI Cooper and Cooper S vehicles because the power steering system may fail, requiring extra effort to steer and increasing crash risk.

    Product
    MINI — MINI COOPER, COOPER S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Titanium Rib Surgical Kits

    Resource Optimization & Innovation LLC is recalling 62 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number 800568001, Sterile, OR0658A - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0108-2016·2015-10-14

    Beckman Coulter Recalls MICroSTREP plus 1 and 2 Panels for Manufacturing Error

    Beckman Coulter is recalling MICroSTREP plus 1 and 2 panels because a manufacturing error may cause antimicrobial degradation and false resistant results.

    Product
    MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0057-2016·2015-10-14

    FDA Recalls 114 Sterile Head and Neck Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 114 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800549, Sterile, ET0638 - Head & Neck - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0067-2016·2015-10-14

    Resource Optimization & Innovation LLC Recalls Neurosurgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 181 neurosurgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800562, Sterile, NU0651 - Neuro - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0098-2016·2015-10-14

    Resource Optimization & Innovation Recalls Pediatric Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 158 pediatric surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800554002, Sterile, GS0643B - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0058-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Hip Shoulder Surgical Kits

    Resource Optimization & Innovation LLC is recalling 125 sterile hip shoulder surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800550, Sterile, OR0639 - Hip Shoulder - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0069-2016·2015-10-14

    FDA Recalls VP Shunt Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 200 VP Shunt surgical kits because equipment gloves may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800566, Sterile, NU0655 - VP Shunt - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0091-2016·2015-10-14

    FDA Recalls 510 Sterile Neuro Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 510 sterile neuro surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0043-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile AV Access Surgical Kits

    Resource Optimization & Innovation LLC is recalling 192 sterile AV Access surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0071-2016·2015-10-14

    Resource Optimization & Innovation Recalls 158 Sterile Titanium Rib Surgical Kits

    Resource Optimization & Innovation LLC is recalling 158 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800568, Sterile, OR0658 - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0037-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Shoulder Surgical Kits

    Resource Optimization & Innovation LLC is recalling 832 sterile shoulder surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0047-2016·2015-10-14

    Resource Optimization & Innovation Recalls 840 Sterile Surgical Extremity Packs

    Resource Optimization & Innovation LLC is recalling 840 sterile surgical extremity packs because the equipment glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800525, Sterile, OR0609 - Extremity Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0100-2016·2015-10-14

    FDA Recalls Pediatric Heart Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 57 pediatric heart surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number 800565001, Sterile, CV0654A - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0077-2016·2015-10-14

    FDA Recalls 100 Neurosurgical Kits Due to Potential Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 100 sterile neurosurgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800623, Sterile, NU0787 - Neuro - surgical kit containing light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0041-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Risk

    Resource Optimization & Innovation LLC is recalling 1,220 sterile surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800419, Sterile, GY0488 - D&C Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0081-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits

    Resource Optimization & Innovation LLC is recalling 54 sterile open heart surgical kits because equipment glove components may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 880327, Sterile, CV0758 - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0032-2016·2015-10-14

    FDA Recalls Sterile Surgical Kits Due to Potential Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 3,099 sterile surgical kits because a glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0065-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Head and Neck Surgical Kits

    Resource Optimization & Innovation LLC is recalling 381 sterile Head & Neck surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800559, Sterile, ET0648 - Head & Neck - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0026-2016·2015-10-14

    Ortho Solutions Recalls UltOS 3.5mm Locking Screws Due to Manufacturing Defect

    Ortho Solutions Inc is recalling 875 units of UltOS 3.5mm locking screws because the locking thread feature was not manufactured to specification, creating a risk that the screw may not lock onto the plate.

    Product
    Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0097-2016·2015-10-14

    Resource Optimization & Innovation LLC Recalls Pediatric Surgical Kits

    Resource Optimization & Innovation LLC is recalling 136 sterile pediatric surgical kits because the equipment glove component may contain splits or holes that compromise sterility.

    Product
    regard Item Number: 800554001, Sterile, GS0643A - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0029-2016·2015-10-14

    Resource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Risk

    Resource Optimization & Innovation LLC is recalling 7,904 sterile surgical kits because the equipment glove component may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0095-2016·2015-10-14

    FDA Recalls 230 Sterile C-Section Surgical Kits Due to Sterility Compromise

    Resource Optimization & Innovation LLC is recalling 230 sterile C-section surgical kits because equipment glove components may have splits or holes that compromise sterility.

    Product
    regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0113-2016·2015-10-14

    Olympus MAJ-1606 Instrument Channel Adaptors Recalled for Sterility Breach

    Olympus is recalling MAJ-1606 Instrument Channel Adaptors due to small puncture marks in sterile packaging that may compromise sterility.

    Product
    MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide