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.

32676–32700 of 50502

  • HighFDA (Food)·F-1763-2017·2017-04-05

    Cumberland Valley Creamery Recalls Luqman Cheese Jalapeno Jack Due to E. coli

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

    Product
    Luqman Cheese, Jalapeno Jack, Net Wt. 8 oz. Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1546-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation LLC is recalling 210 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1573-2017·2017-04-05

    Resource Optimization Recalls Sterile Total Knee Procedure Trays Due to Glove Defect

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

    Product
    Regard, Item Number: 880331002, Sterile, OR0762B - Total Knee - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1687-2017·2017-04-05

    Philips V60 Ventilator Recall for False Blower Motor Stall Detection

    Respironics is recalling 2,512 Philips V60 Ventilators with Version 2.20 software because they may falsely detect a blower motor stall, causing the device to shut down and cease ventilatory support.

    Product
    Philips V60 Ventilator with Version 2.20 Software, Description: V 60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV V60 Ventilator,Intl Opt: CFLEX,AVAPS V60 Ventilator,Intl Opt: None V60 Ventilator,English Opt: None V60 Ventilator,Engl Opt: CFLEX,AVAPS V60 Us Demo Unit V60 USED…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1764-2017·2017-04-05

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

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

    Product
    Luqman Cheese, Yellow Cheddar, Net Wt. 8 oz.,. Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1642-2017·2017-04-05

    FDA Recalls Sterile C-Section Procedure Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 230 sterile C-section procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800408003, Sterile, LD0477C - C-Section PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1556-2017·2017-04-05

    FDA Recalls Sterile Custom Procedure Trays Due to Glove Splitting Risk

    Resource Optimization & Innovation Llc is recalling 46 sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800091003, Sterile, LD0692C - C Section - FMOL Lady of Angels
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1550-201·2017-04-05

    Recall of VP Shunt Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 55 VP Shunt procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800566002, Sterile, NU0655B - VP Shunt - Childrens Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1607-2017·2017-04-05

    Recall of Custom Procedure Trays Due to Splitting Light Glove Component

    Resource Optimization & Innovation Llc is recalling 12 custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800549002, Sterile, ET0638B - Head & Neck - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1585-2017·2017-04-05

    Recall of Spohn Arthroscopy Kits Due to Splitting Light Glove Component

    Resource Optimization & Innovation LLC is recalling 36 sterile arthroscopy kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800422002, Sterile, OR0491B - Arthroscopy PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1750-2017·2017-04-05

    Cumberland Valley Creamery Recalls Gouda Cheese Due to E. coli

    Cumberland Valley Creamery is recalling 450 lbs of Dutchland Homestead Gouda cheese because laboratory analysis found E. coli levels exceeding allowed limits.

    Product
    Dutchland Homestead, Gouda, Net Weight 8 oz., Handcrafted & Distributed by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1723-2017·2017-04-05

    Meijer Recalls Caesar Salads Mislabeled as Greek Due to Undeclared Wheat

    Meijer is recalling pre-made Caesar salads that were mislabeled as Greek salads and contain undeclared wheat. The affected products were distributed in six states.

    Product
    Meijer Caesar Salad labeled as Meijer Greek Salad, Single serve salad, packed in plastic containers with printed labels, Keep Refrigerated
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-1669-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

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

    Product
    Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1805-2017·2017-04-05

    Freshbev Deep Beet Blend Recalled for Elevated Patulin Levels

    Freshbev LLC is recalling Deep Beet Blend products due to elevated patulin levels. The recall affects 5-gallon containers and 2-oz immunity shots distributed in five states.

    Product
    KEEP REFIGERATED, DEEP BEET Blend 5 Gal, Ripe Liquid Produce
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1641-2017·2017-04-05

    Recall of Sterile C-Section Procedure Kits Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 690 sterile C-section kits because a light glove component may split, breaking the sterile field.

    Product
    Regard, Item Number: 800408002, Sterile, LD0477B - C-Section PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1592-2017·2017-04-05

    Recall of Regard Sterile Extremity Packs Due to Glove Splitting Risk

    Resource Optimization & Innovation LLC is recalling 590 sterile extremity packs because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800525002 Sterile, OR0609B - Extremity Pack - Westover Hills
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1562-2017·2017-04-05

    Recall of Regard Sterile Major Basin Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 1,548 sterile procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1691-2017·2017-04-05

    Zimmer Biomet Recalls Altius M-INI OCT Spinal Fixation System

    Zimmer Biomet is recalling 141 units of the Altius M-INI OCT Posterior Spinal Fixation System because the driver cannot mate with the screw head tulip.

    Product
    Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1608-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Defect

    Resource Optimization & Innovation LLC is recalling 209 sterile custom procedure trays because a light glove component can split during use, breaking the sterile field.

    Product
    Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-1771-2017·2017-04-05

    Cumberland Valley Creamery Recalls Luqman Cheese Due to E. coli

    Cumberland Valley Creamery is recalling Luqman Cheese, Yellow Colby Buffalo Ranch, because laboratory analysis found levels of generic E. coli exceeding allowed limits.

    Product
    Luqman Cheese, Yellow Colby Buffalo Ranch, Net Weight 8 oz., Dist by: Cumberland Valley Creamery, Mechanicsburg, PA 17055
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1645-2017·2017-04-05

    Recall of Sterile Lap Chole Procedure Kits Due to Glove Splitting

    Resource Optimization & Innovation LLC is recalling 1,224 sterile lap chole procedure kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800409003, Sterile, GS0478B - Lap Chole PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1584-2017·2017-04-05

    Recall of Regard Major Vaginal PK Sterile Procedure Trays

    Resource Optimization & Innovation LLC is recalling 28 sterile procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - Spohn
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1603-2017·2017-04-05

    Recall of Regard Sterile Custom Procedure Trays Due to Glove Splitting

    Resource Optimization & Innovation Llc is recalling 40 kits of Regard sterile custom procedure trays because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1654-2017·2017-04-05

    Recall of Spohn Shoulder System Kits Due to Light Glove Splitting

    Resource Optimization & Innovation LLC is recalling 208 Spohn Shoulder System kits because a light glove component can split, breaking the sterile field.

    Product
    Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn
    Category
    Medical Device
    Distribution
    2 states