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.

32751–32775 of 50502

  • HighFDA (Devices)·Z-1597-2017·2017-04-05

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

    Resource Optimization & Innovation LLC is recalling 45 sterile procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800527004 Sterile, OR0611D - Hip Shoulder PK - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1665-2017·2017-04-05

    Recall of Spohn AV Access Kits Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 306 Spohn AV Access Kits because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1576-2017·2017-04-05

    Recall of Sterile Laparotomy Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 248 sterile laparotomy procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1617-2017·2017-04-05

    Recall of Pediatric Cardiac Catheterization Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 42 pediatric cardiac catheterization trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800555001, Sterile, HT0644A - Pediatric Card Cath - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1574-2017·2017-04-05

    Recall of Regard Sterile Laparoscopic Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 704 sterile laparoscopic procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880341001, Sterile, GS0775A - Laparoscopic - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1593-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 54 kits of Regard sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800526002 Sterile, ET0610B - Head and Neck - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1553-2017·2017-04-05

    Recall of Sterile Lap Chole Procedure Kits Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 420 sterile lap chole procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800528004, Sterile, GS0612D - Lap Chole Pk - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1765-2017·2017-04-05

    Cumberland Valley Creamery Recalls Luqman Sharp Cheddar Cheese for E. coli

    Cumberland Valley Creamery is recalling Luqman Sharp Cheddar Cheese because laboratory analysis found E. coli levels exceeding allowed limits.

    Product
    Luqman Cheese, Sharp Cheddar, Net Wt. 8 oz.., Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1650-2017·2017-04-05

    Recall of Regard Sterile Vascular Procedure Trays Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 372 sterile vascular procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800413004, Sterile, CV0482D- Vascular PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1657-2017·2017-04-05

    FDA Recalls 216 Spohn Laparoscopy Kits Due to Sterile Field Breach Risk

    Resource Optimization & Innovation LLC is recalling 216 Spohn laparoscopy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800417001, Sterile, GY0486A - Laparoscopy Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1570-2017·2017-04-05

    FDA Recalls 18 Sterile Total Hip Procedure Trays Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 18 sterile total hip procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880330004, Sterile, OR0761D - Total Hip - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1586-2017·2017-04-05

    Recall of Regard Custom Procedure Trays Due to Splitting Light Gloves

    Resource Optimization & Innovation LLC is recalling 48 kits of Regard custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800425, Sterile, CV0494 - Av Access PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1625-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 96 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800559001, Sterile, ET0648A - Head & Neck - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1660-2017·2017-04-05

    FDA Recalls Sterile Vaginal Procedure Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 56 sterile major vaginal procedure kits because a light glove component may split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1678-2017·2017-04-05

    FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 660 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1679-2017·2017-04-05

    Molded Products Recalls Non-Sterile Hemodialysis Tubing Connectors

    Molded Products Inc is recalling 400 non-sterile hemodialysis tubing connectors due to a reported leak. The product was distributed to Ontario, Canada.

    Product
    Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1554-2017·2017-04-05

    Recall of Regard Sterile C Section Packs Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 320 sterile C Section Packs because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St Francis
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1672-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 212 Regard sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1746-2017·2017-04-05

    Cumberland Valley Creamery Recalls Luqman White Colby Cheese Due to E. coli

    Cumberland Valley Creamery is recalling Luqman White Colby cheese because laboratory analysis found levels of generic E. coli exceeding allowed limits.

    Product
    Luqman Cheese, White Colby, Net Wt. 8 oz.., Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1609-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 55 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800550002, Sterile, OR0639B - Hip Shoulder - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1579-2017·2017-04-05

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

    Resource Optimization & Innovation Llc is recalling 460 Regard Ortho PK Spohn custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800407002, Sterile, OR0476B - Ortho PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1551-2017·2017-04-05

    Recall of Spohn Shoulder System Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 112 sterile Spohn Shoulder System kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1583-2017·2017-04-05

    Recall of Spohn Total Joint PK Procedure Trays Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 86 sterile Total Joint PK procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800414001, Sterile, OR0483A - Total Joint PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1744-2017·2017-04-05

    Cumberland Valley Creamery Recalls Monterey Jack Cheese for E. coli

    Cumberland Valley Creamery is recalling Luqman and Dutchland Homestead Monterey Jack cheese because laboratory tests found E. coli levels exceeding allowed limits.

    Product
    Luqman Cheese, Monterey Jack, Net Wt. 8 oz.., Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA Dutchland Homestead, Monterey Jack Cheese, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1696-2017·2017-04-05

    Hitachi Aloka Prosound F75 Ultrasound System Recalled for Loosened Monitor Arm

    Hitachi Aloka Medical is recalling Prosound F75 ultrasound systems because the monitor arm may loosen. Affected units were distributed to specific US states.

    Product
    Prosound F75 or F75 The Hitachi Aloka Medical, Ltd. Prosound F75 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal; Abdominal; Intra-operative; Intra-operative (neurosurgery); Laparoscopic; Pediatric; Small…
    Category
    Medical Device
    Distribution
    Distributed nationwide