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.

27901–27925 of 50462

  • HighFDA (Devices)·Z-2845-2018·2018-08-29

    Philips DigitalDiagnost Footplate Hook Recall for Injury Risk

    Philips is recalling DigitalDiagnost Release 3.1 units because a defective hook allows the footplate to fall or swing, posing an injury risk to operators or patients.

    Product
    DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1844-2018·2018-08-29

    Simplot Good Grains Exotic Grains Blend Recalled for Undeclared Wheat

    J R Simplot Co. is recalling Simplot Good Grains Exotic Grains & Fire-Roasted Vegetable Blend due to undeclared wheat. The frozen product was distributed in 16 states.

    Product
    Simplot Good Grains Exotic Grains & Fire-Roasted Vegetable Blend, Net Wt. 15 lbs (6 / 2.5 lb bags per case), UPC 1007117012948, Distributed by JR Simplot Co. PO Box 9386, Boise, ID 83707. Product is frozen. The label is read in parts: "***EXOTIC GRAINS & FIRE-ROASTED…
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-2841-2018·2018-08-29

    Philips DigitalDiagnost 2.x Upgrades Recalled Due to Footplate Injury Risk

    Philips is recalling two DigitalDiagnost 2.x Upgrades because a defective hook allows the footplate to fall or swing, posing a risk of injury to operators or patients.

    Product
    DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2877-2018·2018-08-29

    TriMed Ulnar Osteotomy Compression Plate Recalled for Manufacturing Defect

    TriMed Inc. is recalling 722 Ulnar Osteotomy Compression Plates because instrument holes are located on the wrong side of the plate.

    Product
    Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2875-2018·2018-08-29

    Zimmer Biomet Recalls Connecting Bolts Due to Material Error

    Zimmer Biomet is recalling 247 connecting bolts made from incorrect material, which may decrease fatigue strength and lead to fracture.

    Product
    Connecting Bolt, Model 14-442093
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-2872-2018·2018-08-29

    GE Healthcare Optima CT540 Systems Recalled for Damaged Cable Hazard

    GE Healthcare is recalling Optima CT540 systems because a damaged cable may expose 120VAC to service engineers working inside the gantry.

    Product
    GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under the following product names: BEIJING CT OPTIMA 540, BEIJING OPTIMA, BEIJING OPTIMA 540, BEIJING OPTIMA 540 ASIR, CT BEIJING…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2862-2018·2018-08-29

    Philips DigitalDiagnost Footplate Hook Recall Due to Injury Risk

    Philips is recalling DigitalDiagnost Release 3.1 units because a defective hook allows the footplate to fall or swing, posing a risk of injury to patients or operators.

    Product
    DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2752-2018·2018-08-29

    Handicare C Series Patient Lifts Recalled for Premature Strap Wear

    Handicare USA Inc. is recalling 716 C Series Patient Lifts because straps may wear and break prematurely at maximum weight conditions.

    Product
    Handicare C Series Patient Lift Product Usage: A device used to lift and transport a patient from one place to another.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2856-2018·2018-08-29

    Philips DigitalDiagnost Classic 1.x Upgrades Recalled for Footplate Safety Hazard

    Philips is recalling DigitalDiagnost Classic 1.x Upgrades because the footplate hook may fail to hold the plate securely, posing a risk of injury to patients or operators.

    Product
    DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1845-2018·2018-08-29

    Boar's Head Sweet Vidalia Onions Recalled Due to Glass Contamination

    Vidalia Valley, Inc. is recalling Boar's Head Sweet Vidalia Onions in Sauce because the product contains glass.

    Product
    Boar's Head Brand Sweet Vidalia Onions in Sauce, glass jars 9oz UPC 0 42421 06956 3 & 64 oz UPC 0 42421 26517 0. DISTRIBUTED BY: BRUNCKHORST CO., NY, NY 11206-3886
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2887-2018·2018-08-29

    CAREstream ProNox Nitrous Oxide Delivery Systems Recalled for High Gas Levels

    CAREstream Medical LLC is recalling 919 ProNox Nitrous Oxide Delivery Systems because two units delivered higher levels of nitrous oxide than specified during routine testing.

    Product
    CAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-Nox Mixer - Canadian; b. CMI-0100-PNX-HS, Pro-Nox Complete Hospital Roll Stand System - Nitrous Oxide Delivery System; c. CMI-0100-PNX-HS-NO2H, Pro-Nox Hospital System…
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Food)·F-1841-2018·2018-08-29

    TeaSource Roasted Chestnut Loose Leaf Tea Recalled for Undeclared Almonds

    TeaSource is recalling Roasted Chestnut loose leaf tea because it contains undeclared slivered almonds. The product was distributed in 17 states.

    Product
    TeaSource Roasted Chestnut, loose leaf tea. packaged in 16 oz. (454g)Metal/Poly non-resealable bag, and 4 oz., and 2 oz. resealable foil bags. teasource.com, 2616 Cleveland Ave N, Roseville, MN 55113.
    Category
    Food
    Distribution
    17 states
  • HighFDA (Food)·F-1850-2018·2018-08-29

    Reser's Bow Tie Pasta Caesar Recalled for Potential Cyclospora Contamination

    Reser's Fine Foods is recalling Bow Tie Pasta Caesar due to potential Cyclospora contamination from spinach ingredients.

    Product
    Bow Tie Pasta Caesar Molly's Kitchen, item # 58108.76434, Inner Containter Item # 58108.30168, 2/4.5 # packages per case. UPC 0 58108 30168 9. Product is pasta salads with vinaigrette dressings and vegetables including spinach. All products are in white plastic tubs with…
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-2855-2018·2018-08-29

    Philips DigitalDiagnost 4.1 High Performance Footplate Recall Issued

    Philips is recalling DigitalDiagnost 4.1 High Performance units because a defective hook allows the footplate to fall or swing, posing an injury risk to patients and operators.

    Product
    DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2884-2018·2018-08-29

    Stryker T2 Orthopedic Nails Recalled for Incomplete Sterility Seal

    Stryker GmbH is recalling 38 T2 orthopedic nails due to incomplete Tyvek lid seals that may compromise sterility.

    Product
    Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S T2 LONG PROXIMAL HUMERAL NAIL LEFT 240mm1832-2824S T2 LONG PROXIMAL HUMERAL NAIL LEFT 280mm 1832-2828S T2 LONG PROXIMAL HUMERAL NAIL RIGHT 260mm…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2852-2018·2018-08-29

    Philips DigitalDiagnost 4.1 Footplate Hook Recall for Injury Risk

    Philips is recalling DigitalDiagnost 4.1 units because a defective hook allows the footplate to fall, posing a risk of injury to patients or operators.

    Product
    DigitalDiagnost 4.1 (Stitching Patient Support) 712225
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2851-2018·2018-08-29

    Philips DigitalDiagnost 4 Footplate Hook Recall for Injury Risk

    Philips is recalling DigitalDiagnost 4 High Performance units because a defective hook allows the footplate to fall or swing, posing an injury risk to patients and operators.

    Product
    DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2863-2018·2018-08-29

    Philips DigitalDiagnost Single Detector Footplate Hook Recall

    Philips is recalling DigitalDiagnost Single Detector units because a defective hook allows the footplate to fall or swing, posing a risk of injury to patients or operators.

    Product
    DigitalDiagnost Single Detector (Stitching Patient Support) 712020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1848-2018·2018-08-29

    Reser's Stonemill Kitchens Three Cheese Pasta Spinache Recalled for Cyclospora

    Reser's Fine Foods is recalling Three Cheese Pasta Spinache Stonemill Kitchens due to potential Cyclospora contamination in the spinach ingredient.

    Product
    Three Cheese Pasta Spinache Stonemill Kitchens, item # 71117.19500, 2/5 # packages. UPC 0 71117 19500 2. Product is pasta salads with vinaigrette dressings and vegetables including spinach. All products are in white plastic tubs with labeled lids packed 2/5 # to a…
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-2865-2018·2018-08-29

    Philips DigitalDiagnost Dual-Detector Recall for Footplate Safety Hazard

    Philips is recalling DigitalDiagnost Dual-Detector units because a defective hook allows the footplate to fall or swing, posing an injury risk to patients and operators.

    Product
    DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1960-2018·2018-08-29

    Zucchini Noodles Recalled Due to Listeria monocytogenes Contamination Risk

    Banks Square Market Corp is recalling zucchini noodles sold under The Pick and Whole Foods brands due to potential Listeria monocytogenes contamination.

    Product
    Zuchini noodles packaged under the following brands - the PICK, NET WT 16 OZ, UPC: 8 54340 00700 3; Whole Foods, UPC: 0 36406 30488 6
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2885-2018·2018-08-29

    O-Two Equinox Relieve Gas System Recalled for High Nitrous Oxide Levels

    O-Two Medical Technologies is recalling three Equinox Relieve gas systems because they may deliver higher levels of nitrous oxide than specified.

    Product
    O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery System Model#: 01EQ1000
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2846-2018·2018-08-29

    Philips BuckyDiagnost Ceiling System Recalled for Footplate Safety Hazard

    Philips is recalling BuckyDiagnost Ceiling Systems because the footplate hook may fail to hold the plate securely, posing a risk of injury to patients or operators.

    Product
    BuckyDiagnost Ceiling System (Stitching Patient Support) 704031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2857-2018·2018-08-29

    Philips DigitalDiagnost Classic Footplate Hook Recall for Injury Risk

    Philips is recalling DigitalDiagnost Classic units because a defective hook allows the footplate to fall or swing, posing an injury risk to patients and operators.

    Product
    DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2871-2018·2018-08-29

    GE Healthcare Optima CT660 Recall for Damaged Cable Electrical Hazard

    GE Healthcare is recalling Optima CT660 systems because a damaged cable may expose 120VAC to service engineers working inside the gantry.

    Product
    GE Healthcare Optima CT660. Sold under the following product names: BEIJING OPTIMA CT660 PRO GT170, BEIJING OPTIMA CT660 PRO GT200, BEIJING OPTIMA CT660S PRO 32 S, CT GOLDSEAL, CT GOLDSEAL OPTIMA 660, CT GOLDSEAL OPTIMA 660 UT-BUC, CT OPTIMA 660 LNG HN P20, CT OPTIMA…
    Category
    Medical Device
    Distribution
    Distributed nationwide