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.

23626–23650 of 50435

  • HighFDA (Devices)·Z-1414-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled for Unknown Contamination Levels

    DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Cystoscopy Pack 89-6071.15
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1419-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled for Unknown Contamination Levels

    DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Ocular Plastics Pack 89-6498.13
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1412-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination

    DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Shoulder Pack 89-4751.08
    Category
    Medical Device
    Distribution
    2 states
  • HighNHTSA·20V134000·2020-03-06

    Triple E RV Recalls 2020 Wonder Travel Trailers Due to Fire Risk

    Triple E Recreational Vehicles is recalling 2020 Wonder travel trailers because unprotected ceiling light wires can chafe and arc, increasing the risk of a fire.

    Product
    TRIPLE E RV — TRIPLE E RV WONDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E011000·2020-03-06

    Joyson Recalls Rear Seat Belt Retractors for Restraint Failure

    Joyson is recalling certain rear seat belt retractors because the locking mechanism may not properly restrain occupants, increasing injury risk in a crash.

    Product
    SEAT BELTS:REAR/OTHER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20086·2020-03-05

    ECHO and Shindaiwa Recall Backpack Blowers Due to Laceration Hazards

    ECHO and Shindaiwa are recalling about 67,700 backpack blowers and 6,600 replacement straps because parts can be expelled, posing laceration and impact risks.

    Product
    ECHO and Shindaiwa Backpack Blowers and replacement straps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1355-2020·2020-03-04

    Cook Inc. Recalls Zenith Alpha Spiral-Z Endovascular Leg Grafts

    Cook Inc. is recalling Zenith Alpha Spiral-Z Endovascular Leg grafts due to identified factors contributing to thrombus formation and lumen occlusion. The product is distributed only outside the United States.

    Product
    Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1384-2020·2020-03-04

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

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

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1350-2020·2020-03-04

    Ulrich Medical Recalls Spinal Locking Screws Due to Weld Seam Defect

    Ulrich medical USA Inc is recalling 179 units of neon3 OCT spinal stabilization locking screws because a production error prevents them from reliably transmitting required torque.

    Product
    Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1381-2020·2020-03-04

    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 7.5MM(P) X 4MM(H) Reference Number: IEHA474
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1393-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 1,725 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, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V, 100103HS3D-V, 100152HS3D-V, 100153HS3D-V, 100154HS3D-V, 100202HS3D-V, 100203HS3D-V, 100204HS3D-V, 100206HS3D-V, 100208HS3D-V…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1394-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 486 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 Regular, Sterile, Rx, REF numbers 100515HC-R-V, 100515HCSR-R-V, 100520HC-R-V, 100520HCSR-R-V, 100620HC-R-V, 100620HCSR-R-V, 100730HC-R-V, 100730HCSR-R-V, 100830HC-R-V…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0754-2020·2020-03-04

    Lotte Choco Pie Banana Recalled for Undeclared Almond

    Lotte Choco Pie Banana is being recalled because FDA testing found undeclared almond protein. Consumers with this product should stop eating it.

    Product
    Lotte Choco Pie Banana, 12 pack, 11.85 oz. (336 g) UPC: 8 45502 06140 7 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 (Food)·F-0752-2020·2020-03-04

    Lotte Choco Pie Cocao Recalled for Undeclared Almond Protein

    Lotte International America is recalling Lotte Choco Pie Cocao because FDA testing found undeclared almond protein in the product.

    Product
    Lotte Choco Pie Cocao, 12 pack, 11.85 oz. (336 g) UPC: 8 801062 475148 Distributed by Lotte International America, Los Angeles, CA Product of Korea
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1404-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coils

    MicroVention is recalling 85 units of Microplex 10 Platinum Coil Systems because the implant coil may be missing from the packaging.

    Product
    MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V, 100408CMSR-V, 100412CMSR-V, 100510CMSR-V, 100516CMSR-V, 100612CMSR-V, 100618CMSR-V, and 100721CMSR-V. Product Usage: The MCS is also…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1403-2020·2020-03-04

    MicroVention HydroFrame 18 Embolic System Recalled for Missing Implant Coil

    MicroVention is recalling 32 units of HydroFrame 18 embolic systems because the implant coil may be missing. The devices were distributed internationally.

    Product
    MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, and MV-81036HHFA. Product Usage: The HES is also intended for vascular…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1342-2020·2020-03-04

    Philips Ambulance Parameter Extension Kit Recalled for ECG Signal Loss

    Philips is recalling 43 Ambulance Parameter Extension kits because they may cause ECG 'Leads Off' errors in hot, humid environments.

    Product
    Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1399-2020·2020-03-04

    MicroVention Platinum Embolization Coils Recalled for Missing Implant Coil

    MicroVention is recalling 403 units of Platinum Embolization Coils because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF numbers 180619CS-V, 180723CS-V, 180827CS-V, 180931CS-V, 181036CS-V, 181139CS-V, 181243CS-V, 181347CS-V, 181451CS-V, 181652CS-V, 181859CS-V, 182065CS-V, 182263CS-V, and 182468CS-V…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0738-2020·2020-03-04

    Lanvin French Bakery Recalls Deep-Fried Donuts for Undeclared Allergens

    Lanvin French Bakery is recalling 49 bags of deep-fried donuts (Banh Tieu) distributed in Oregon and Washington due to undeclared wheat and soybean oil.

    Product
    Deep-fried Donut (Banh Tieu) 3.2-ounce package in clear plastic bag, no UPC, no brand. Product is labeled in part, "BANH TIEU***Ingredients: bread flour, sugar, baking powder, salt, sesame seed, water, shortening oil.***Lanvin French Bakery***".
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1383-2020·2020-03-04

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

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

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2020·2020-03-04

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

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

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Reference Number: IEHA443
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1407-2020·2020-03-04

    MicroVention Platinum Coil System Recall for Missing Implant Coils

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

    Product
    MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile, Rx, REF numbers 100101HS-V, 100102HS-V, 100103HS-V, 100104HS-V, 100151HS-V, 100152HS-V, 100153HS-V, 100154HS-V, 100201HS-V, 100202HS-V, 100203HS-V, 100204HS-V…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1406-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 666 units of Platinum Coil Systems because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315VFC, MV-00310VFC, MV-00630VFC, VFC010303-V, VFC030606-V, VFC030610-V, VFC030615-V, VFC061020-V, VFC061030-V, VFC101530-V, VFC101540-V…
    Category
    Medical Device
    Distribution
    1 state