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.

23651–23675 of 50435

  • HighFDA (Devices)·Z-1373-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H) Reference Number: IEHA444
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V128000·2020-03-04

    Horton Ambulances Recalled for Electrical Short Circuit Risk

    Halcore Group is recalling 2016-2019 Horton Type I and III ambulances because an undersized A/C power cord may cause an electrical short circuit, increasing the risk of fire or shock.

    Product
    HORTON — HORTON TYPE I, TYPE III
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1398-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 3,442 units of Platinum Coil Systems because the implant coil may be missing from the packaging.

    Product
    MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10, Sterile, Rx, REF numbers 100202CSSR-V, 100254CSSR-V, 100306CSSR-V, 100408CSSR-V, 100412CSSR-V, 100515CSSR-V, 100522CSSR-V, 100618CSSR-V, 100626CSSR-V, 100722CSSR-V, 100731CSSR-V…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1392-2020·2020-03-04

    MicroVention HydroSoft 10 Embolic Coils Recalled for Missing Implant Coil

    MicroVention is recalling 2,762 units of HydroSoft 10 embolic coils because the implant coil may be missing from the packaging.

    Product
    MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V; 100102H2HS-V, 100103H2HS-V, 100104H2HS-V, 100151H2HS-V; 100152H2HS-V; 100153H2HS-V; 100154H2HS-V; 100201H2HS-V; 100202H2HS-V; 100203H2HS-V…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0757-2020·2020-03-04

    Annie Chun's Teriyaki Noodle Bowl Recalled for Undeclared Peanuts

    CJ Foods is recalling Annie Chun's Teriyaki Noodle Bowls because they were packaged with sleeves for Pad Thai bowls, leaving peanuts undeclared on the label.

    Product
    Annie Chun's Japanese Style Teriyaki Noodle Bowl with Cooked Hokkien Noodles - Sweet & Tangy sauce with Bok choy and carrots. Noodles are in Opaque White Plastic bowl with paper sleeves. Net Wt. 7.8 oz. (221g) UPC: 7-65667-10387-6 Add 1 1/4 water and microwave on high…
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1369-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Misalignment

    Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation or margin contour misalignment in dental impressions.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0739-2020·2020-03-04

    Lanvin French Bakery Recalls Deep-Fried Bread for Undeclared Wheat and Soybean Oil

    Lanvin French Bakery is recalling 26 bags of deep-fried bread (Banh Gio Chao Quay) in Oregon and Washington due to undeclared wheat and soybean oil.

    Product
    Deep-fried Bread (Banh Gio Chao Quay) 6-ounce package in clear plastic bag, no UPC, no brand. Product is labeled in part, "BANH GIO CHAO QUAY***Ingredients: bread flour, sugar, salt, baking powder, vegetable oil, water.***Lanvin French Bakery***".
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1405-2020·2020-03-04

    MicroVention HydroSoft Embolization Coils Recalled for Missing Implant Coils

    MicroVention is recalling 847 HydroSoft embolization coils because the implant coil may be missing from the packaging. The devices were distributed to 43 countries outside the United States.

    Product
    MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, 100206HFRM-V, 100208HFRM-V, 100254HFRM-V, 100256HFRM-V, 100308HFRM-V…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0800-2020·2020-03-04

    Coburn Farms Snackers Recalled for Undeclared Peanut Labeling Error

    Great Lakes Cheese Co Inc is recalling Coburn Farms Snackers due to a labeling error that failed to declare peanut as an ingredient.

    Product
    Coburn Farms Snackers, Sharp Yellow Cheddar Cheese, Cherry Juice Infused Dried Cranberries & Roasted Sea Salted Cashews, 3 Pack, Net Wt 4.5 oz (127.5g) 3-1.5 oz (42.5g) packs, Keep Refrigerated. UPC 51933-36243. Distributed By: Save-A-Lot Food Stores, Ltd., Earth City, MO…
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-1343-2020·2020-03-04

    Hologic Selenia Dimensions Mammography System Recalled for C-Arm Defects

    Hologic is recalling 72 Selenia Dimensions Mammography Systems because the C-arm may seize or drop during repairs and cleaning.

    Product
    Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1356-2020·2020-03-04

    Zimmer Sterile Disposable Tourniquet Cuff Recalled for Bladder Leak

    Zimmer Surgical Inc is recalling 58 units of sterile tourniquet cuffs because a leak between bladders may cause both to inflate or deflate simultaneously.

    Product
    Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547 (17)230812(10)27968701 The product is a tourniquet - Product Usage: Tourniquets are intended to be used by qualified medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1351-2020·2020-03-04

    St Jude Ellipse ICD Recall for Wireless Communication Loss

    St Jude Medical is recalling 256 Ellipse ICDs because past updates may cause loss of wireless communication, preventing remote patient monitoring.

    Product
    Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with…
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1374-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Fit Issues

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1347-2020·2020-03-04

    Zimmer Biomet Recalls THP Hip Plating System Due to Fracture Risk

    Zimmer Biomet is recalling 1,662 units of the THP Hip Plating System after internal testing detected a potential increase in fracture rate and packaging discoloration.

    Product
    THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-1395-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention, Inc. is recalling 780 units of Microplex 10 Platinum Coil Systems because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HCSR-S-V, 100310HC-S-V, 100310HCSR-S-V, 100410HC-S-V, 100410HCSR-S-V…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1401-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 19 units of the Microplex 18 Platinum Coil System because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, 180820CC-V, 181026CC-V, 181434CC-V, and 182050CC-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1352-2020·2020-03-04

    Breas Medical Recalls Vivo Ventilator Protective Covers Due to Obstruction Risk

    Breas Medical is recalling 629 Vivo ventilator protective covers because the design may obstruct the exhalation valve control pressure tube.

    Product
    Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1400-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention is recalling Microplex 10 Platinum Coil Systems because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF numbers 100204CC-V, 100307CC-V, 100410CC-V, 100512CC-V, 100615CC-V, 100718CC-V, 100820CC-V, 100924CC-V, and 101026CC-V. Product Usage: The MCS is also intended…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1370-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA354
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1378-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

    Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1397-2020·2020-03-04

    MicroVention Platinum Coil System Recall for Missing Implant Coils

    MicroVention is recalling 169 units of Microplex 18 Platinum Coil Systems because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204HC-S-V, 180208HC-S-V, 180308HC-S-V, 180410HC-S-V, and 180512HC-S-V. Product Usage: The MCS is also intended for vascular occlusion of blood…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0750-2020·2020-03-04

    Domino Foods Recalls SYSCO Brown Sugar Due to Foreign Material

    Domino Foods is recalling SYSCO Classic Light Brown Cane Sugar because it may contain foreign material. The product was distributed to 23 states and Saudi Arabia.

    Product
    SYSCO Classic Light Brown Cane Sugar, 25 LB bag, UPC 074865990301, Lots 50043 (Best By Jan 22, 2022) & 50045 (Best By Jan 24, 2022)
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-0753-2020·2020-03-04

    Lotte Choco Pie Recalled for Undeclared Almond Allergen

    Lotte Choco Pie Original is being recalled because FDA testing found undeclared almond protein in the product.

    Product
    Lotte Choco Pie Original, 12 pack 11.85 oz. (336 g) UPC: 8 801062 160709 Distributed by Lotte International America, Los Angeles, CA Product of Korea Contains: Wheat, soy, Egg. Manufactured in a facility that also processes Almond, Peanut.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1396-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 9 units of Microplex 18 Platinum Coil Systems because the implant coil may be missing from the packaging.

    Product
    MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Regular, Sterile, Rx, REF numbers 180520HC-R-V and 181230HC-R-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system…
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·20T005000·2020-03-03

    Tires Recalled for Sidewall Separation Defect

    Sentury Tire is recalling certain sidewall-tired models because a manufacturing defect causes the sidewall to separate, potentially leading to tire failure and increased crash risk.

    Product
    TIRES:SIDEWALL recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide