The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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14101–14125 of 27500

  • 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
  • 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
  • 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 (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 (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 (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 (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
  • CriticalFDA (Devices)·Z-1135-2020·2020-02-26

    Abbott NC TREK Coronary Dilatation Catheters Recalled for Balloon Deflation Issues

    Abbott Vascular is recalling NC TREK Coronary Dilatation Catheters because the balloon may be difficult or unable to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving…
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0942-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect

    Philips Respironics is recalling 21 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

    Product
    Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the…
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0952-2020·2020-02-26

    Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

    Philips Respironics is recalling specific Trilogy EVO ventilators because a software defect causes power alarms to fail, potentially leaving patients without critical alerts.

    Product
    Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the…
    Category
    Medical Device
    Distribution
    0 states