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.

32701–32725 of 50502

  • HighFDA (Devices)·Z-1566-2017·2017-04-05

    Recall of Sterile Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 32 sterile custom procedure trays because a light glove component can split and break the sterile field.

    Product
    Regard, Item Number: 880327009, Sterile, CV0758I - Open Heart A&B - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1590-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation Llc is recalling 180 kits of Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800524004, Sterile, LD0608D - C Section - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1571-2017·2017-04-05

    Recall of Regard Total Hip Procedure Trays Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 14 sterile total hip procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880330005, Sterile, OR0761E - Total Hip - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1557-2017·2017-04-05

    Resource Optimization & Innovation Recalls Sterile Breast PK Procedure Trays

    Resource Optimization & Innovation Llc is recalling 16 sterile breast PK procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880321002, Sterile, GS0752B - Breast PK - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1676-2017·2017-04-05

    Recall of Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 30 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880327006, Sterile, CV0758F - Open Heart A&B - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1751-2017·2017-04-05

    Cumberland Valley Creamery Recalls Dutchland Homestead American Cheese for E. coli

    Cumberland Valley Creamery is recalling 401 lbs of Dutchland Homestead American Cheese because laboratory analysis found E. coli levels exceeding allowed limits.

    Product
    Dutchland Homestead, American Cheese, Net Weight 8 oz.., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055;
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1653-2017·2017-04-05

    Recall of Spohn Shoulder System Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 382 sterile Spohn Shoulder System kits because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1591-2017·2017-04-05

    Recall of Regard Sterile Extremity Packs Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 456 sterile extremity packs because a light glove component may split, breaking the sterile field.

    Product
    Regard, Item Number: 800525001, Sterile, OR0609A - Extremity Pack - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1622-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 148 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800558002, Sterile, OR0647B - Extremity - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1692-2017·2017-04-05

    UOC Femoral Driver Recalled Due to Locking Lever Pin Breakage Risk

    United Orthopedic Corporation is recalling 33 UOC Femoral Drivers because the locking lever pin may deform and break, causing the device to malfunction during surgery.

    Product
    UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1652-2017·2017-04-05

    Recall of Regard Sterile Total Joint Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 496 sterile total joint kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1552-2017·2017-04-05

    FDA Recalls Sterile Breast Procedure Kits Due to Glove Splitting Risk

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

    Product
    Regard, Item Number: 880321001, Sterile, GS0752A - Breast Pk - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1632-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 46 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800568005, Sterile, OR0658E - Titanium Rib - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1610-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation Llc is recalling 90 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800551001, Sterile, GS0640A - Lap Chole - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1572-2017·2017-04-05

    Recall of Regard Total Knee Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 22 sterile total knee procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880331001, Sterile, OR0762A - Total Knee - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1587-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 10 kits of Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1756-2017·2017-04-05

    Cumberland Valley Creamery Recalls Unlabeled Feta Cheese for E. coli

    Cumberland Valley Creamery is recalling unlabeled feta cheese because laboratory analysis found E. coli levels exceeding allowed limits.

    Product
    Feta, unlabeled, Manufactured for repack and relabel cheeses.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1611-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 100 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1547-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 90 sterile Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1784-2017·2017-04-05

    Kusher LLC Recalls Cookies Assorti Due to Allergen Mislabeling

    Kusher LLC is recalling Cookies Assorti because the packaging failed to list egg and milk in the 'Contains' statement, posing a risk to allergic consumers.

    Product
    Cookies ASSORTI, product is packaged in plastic clamshells container, Net Weight: 454g (16 OZ). UPC: 8 51929 00358 6. The label is read in parts: "***COOKIES "ASSORTI" *** INGREDIENTS: WHEAT FLOUR, NIACIN, REDUCE IRON THIAMINE, MONONITRATE, RIBOFLAVIN, FOLIC ACID, BUTTER…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1733-2017·2017-04-05

    Bitterman and Sons Recalls Parmesan Truffle Salt for Undeclared Milk Allergen

    Bitterman and Sons is recalling Parmesan Truffle Salt because the label declares Parmigiano Reggiano cheese but fails to list milk as an ingredient.

    Product
    Parmesan Truffle Salt. The product is packaged in glass taster cork jars (0.9 oz.) with cork top lid, glass small jars (1.8 oz.) with glass lids, and glass large jars (6.1 oz.) with glass lids. Sold as single items. The label is read in parts: "***Parmesan Truffle Salt***…
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1637-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation Llc is recalling 240 sterile Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800623001, Sterile, NU0787A - Neuro - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1758-2017·2017-04-05

    Cumberland Valley Creamery Recalls Havarti Caraway Cheese for E. coli

    Cumberland Valley Creamery is recalling Havarti Caraway cheese because laboratory analysis found levels of E. coli exceeding allowed limits.

    Product
    Havarti Caraway, unlabeled, Manufactured for repack and relabel cheeses.
    Category
    Food
    Distribution
    2 states