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.

32651–32675 of 50502

  • HighFDA (Devices)·Z-1619-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 356 Regard custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1673-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

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

    Product
    Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1563-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 48 kits of Regard sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1697-2017·2017-04-05

    Merge Healthcare Recalls iConnect Enterprise Archive Software Due to Data Access Issues

    Merge Healthcare is recalling iConnect Enterprise Archive software because archived studies cannot be opened or sent to PACS, preventing physicians from reviewing comparison studies.

    Product
    iConnect Enterprise Archive (ICEA) software. iConnect Enterprise Archive is intended for use as a vendor neutral archive for storage and communications of medical images and data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1674-2017·2017-04-05

    Recall of Regard Sterile Abdominal Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 210 sterile abdominal procedure kits because a light glove component may split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1747-2017·2017-04-05

    Cumberland Valley Creamery Recalls Mozzarella for E. coli Contamination

    Cumberland Valley Creamery is recalling Dutchland Homestead Mozzarella because laboratory analysis found E. coli levels exceeding allowed limits.

    Product
    Dutchland Homestead Mozzarella, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1601-2017·2017-04-05

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

    Resource Optimization & Innovation Llc is recalling 290 sterile abdominal procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800533003 Sterile, GS0606C - Abdominal PK - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1577-2017·2017-04-05

    Recall of Regard Sterile Laparotomy Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 78 sterile laparotomy kits because a light glove component may split, breaking the sterile field.

    Product
    Regard, Item Number: 880342003, Sterile, GS0776C - Laparotomy - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1640-2017·2017-04-05

    Recall of Regard Sterile Ortho PK Spohn Procedure Trays

    Resource Optimization & Innovation LLC is recalling 840 sterile procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800407004, Sterile, OR0476D - Ortho PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1664-2017·2017-04-05

    Recall of Sterile Arthroscopy Kits Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 162 sterile arthroscopy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800422004, Sterile, OR0491D - Arthroscopy Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1666-2017·2017-04-05

    Recall of Spohn AV Access Procedure Kits Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 118 Spohn AV Access Procedure Kits because a light glove component may split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1594-2017·2017-04-05

    Resource Optimization Recalls 15 Sterile Custom Procedure Trays

    Resource Optimization & Innovation LLC is recalling 15 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1659-2017·2017-04-05

    Recall of Regard Sterile Vaginal Kits Due to Glove Splitting Hazard

    Resource Optimization & Innovation LLC is recalling 148 sterile vaginal kits because a light glove component may split, breaking the sterile field.

    Product
    Regard, Item Number: 800418002, Sterile, GY0487B - Major Vaginal Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1630-2017·2017-04-05

    FDA Recalls Robotic Hysterectomy Kits Due to Sterile Field Breach Risk

    Resource Optimization & Innovation LLC is recalling 236 robotic hysterectomy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1606-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 180 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800548002, Sterile, OR0637B - Extremity - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1634-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 25 sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1787-2017·2017-04-05

    Kusher LLC Recalls Cookies Fantazia Due to Undeclared Egg and Milk Allergens

    Kusher LLC is recalling 476 packages of Cookies Fantazia because the label failed to declare egg and milk allergens. The product was distributed in California, Oregon, and Washington.

    Product
    COOKIES FANTAZIA, product is packaged in plastic clamshells container, Net Weight: 454g (16 OZ), UPC: UPC: 8 51929 00361 6 The label is read in parts: "***COOKIES "FANTAZIA" *** INGREDIENTS: WHEAT FLOUR (WHEAT FLOUR, NIACIN, REDUCE IRON, THIAMINE MONONITRATE, RIBOFLAVIN…
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1636-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 92 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800599001, Sterile, GS0694A - Robotic Lap - Christus Highland
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1560-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 30 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1588-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 70 kits of Regard sterile custom procedure trays because a light glove component can split during application, breaking the sterile field.

    Product
    Regard, Item Number: 800524002, Sterile, LD0608B - C Section - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1618-2017·2017-04-05

    Recall of Pediatric Cardiac Catheterization Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 27 pediatric cardiac catheterization trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800555002, Sterile, HT0644B - Pediatric Card Cath - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1755-2017·2017-04-05

    Cumberland Valley Creamery Recalls Unlabeled Gouda Cheese for E. coli

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

    Product
    Gouda, unlabeled, Manufactured for repack and relabel cheeses.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1631-2017·2017-04-05

    Recall of Robotic Hysterectomy Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 206 sterile robotic hysterectomy procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1768-2017·2017-04-05

    Cumberland Valley Creamery Recalls Yellow Colby Cheese for E. coli

    Cumberland Valley Creamery is recalling Luqman Cheese, Yellow Colby, because laboratory analysis found the product exceeded allowed limits of generic E. coli.

    Product
    Luqman Cheese, Yellow Colby, Net Wt. 8 oz.., Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA
    Category
    Food
    Distribution
    2 states