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.

32726–32750 of 50502

  • HighFDA (Food)·F-1745-2017·2017-04-05

    Cumberland Valley Creamery Recalls Luqman White Cheddar Cheese

    Cumberland Valley Creamery is recalling Luqman White Cheddar cheese due to laboratory findings of E. coli exceeding allowed limits.

    Product
    Luqman Cheese, White Cheddar, Net Wt. 8 oz.., Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1596-2017·2017-04-05

    Recall of Regard Sterile Hip Shoulder Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 40 sterile procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800527003 Sterile, OR0611C - Hip Shoulder PK - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1748-2017·2017-04-05

    Cumberland Valley Creamery Recalls Dutchland Homestead Farmer's Cheese Due to E. coli

    Cumberland Valley Creamery is recalling Dutchland Homestead Farmer's Cheese because laboratory analysis found levels of E. coli exceeding allowed limits.

    Product
    Dutchland Homestead Farmer's Cheese, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1667-2017·2017-04-05

    Recall of Regard Sterile Procedure Trays Due to Splitting Glove Component

    Resource Optimization & Innovation LLC is recalling 126 kits of Regard sterile procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1600-2017·2017-04-05

    Recall of Regard Sterile Abdominal PK Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 200 sterile abdominal procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1670-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Sterile Field Breach

    Resource Optimization & Innovation LLC is recalling 32 kits of Regard custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1604-2017·2017-04-05

    FDA Recalls 170 Custom Procedure Trays Due to Sterile Field Breach Risk

    Resource Optimization & Innovation LLC is recalling 170 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800546001 Sterile, GS0635A - Abdominal - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1595-2017·2017-04-05

    Recall of Regard Sterile Hip Shoulder Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 12 kits of Regard sterile procedure trays because a light glove component can split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800527002 Sterile, OR0611B - Hip Shoulder PK - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1582-2017·2017-04-05

    FDA Recalls 120 Sterile Total Joint Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 120 sterile Total Joint Procedure Kits because a light glove component may split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1565-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 16 kits of Regard sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 880327008, Sterile, CV0758H - Open Heart A&B - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1684-2017·2017-04-05

    Streck Recalls Cyto-Chex BCT Blood Specimen Collection Tubes

    Streck is recalling 128,692 Cyto-Chex BCT blood specimen collection tubes because the 2.0ml tube stoppers may come loose during phlebotomy if small diameter tube adapters are not used.

    Product
    Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box REF 218980. Streck.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1455-2017·2017-04-05

    Strata Skin Sciences Recalls XTRAC Excimer Lasers Due to Shorted Wires

    Strata Skin Sciences is recalling XTRAC Excimer Lasers because loose switch control wires may short, leading to unintentional laser firing.

    Product
    XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1680-2017·2017-04-05

    Data Innovations Recalls JResultNet Software Due to Patient Data Mismatch Risk

    Data Innovations, LLC is recalling JResultNet software because a defect may cause one patient's test results to be associated with another patient.

    Product
    JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone software package that provides connectivity between in-vitro diagnostic instruments and laboratory information's systems, aiding the flow of laboratory information…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1615-2017·2017-04-05

    Recall of Regard Sterile Total Knee Procedure Trays Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 104 sterile total knee procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800553003, Sterile, OR0642C - Total Knee - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1564-2017·2017-04-05

    Resource Optimization Recalls Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 27 sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 880327007, Sterile, CV0758G - Open Heart A&B - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1629-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 25 kits of Regard custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800562002, Sterile, NU0651B - Neuro - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1568-2017·2017-04-05

    Recall of Pacemaker Procedure Trays Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 26 sterile pacemaker procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1661-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 450 Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1806-2017·2017-04-05

    Freshbev LLC Recalls Immunity Shots Due to Elevated Patulin Levels

    Freshbev LLC is recalling specific lots of IMMUNITY SHOT 2 fl.oz. beverages due to elevated patulin levels. Consumers in five states should check their products.

    Product
    IMMUNITY SHOT 2 fl.oz., UPC: 859168006184
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1675-2017·2017-04-05

    Recall of Titanium Rib Procedure Trays Due to Glove Splitting Hazard

    Resource Optimization & Innovation LLC is recalling 90 sterile procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1548-201·2017-04-05

    Recall of Regard Ortho Pk Spohn Custom Procedure Trays Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 2,122 Regard Ortho Pk Spohn custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800407003, Sterile, OR0476C - Ortho Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1651-2017·2017-04-05

    Recall of Regard Vascular Procedure Trays Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 164 sterile vascular procedure trays because a light glove component may split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1621-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Sterile Field Breach Risk

    Resource Optimization & Innovation LLC is recalling 284 Regard custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800558001, Sterile, OR0647A - Extremity - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states