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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17976–18000 of 40124

  • 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
  • ModerateFDA (Devices)·Z-1376-2020·2020-03-04

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

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

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA454
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1377-2020·2020-03-04

    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 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1375-2020·2020-03-04

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

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

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA453
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1380-2020·2020-03-04

    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 6MM(H) Reference Number: IEHA466
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1367-2020·2020-03-04

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

    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 3.8MM(P) X 4MM(H) Reference Number: IEHA344
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1368-2020·2020-03-04

    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 3.4MM(D) X 3.8MM(P) X 6MM(H) Reference Number: IEHA346
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1364-2020·2020-03-04

    Exactech Recalls Truliant Splined Stem Extensions Due to Labeling Error

    Exactech is recalling four Truliant Splined Stem Extensions because the labels incorrectly identify the implant size as 17mm x 80mm instead of 18mm x 120mm.

    Product
    Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1386-2020·2020-03-04

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

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

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1365-2020·2020-03-04

    bioMerieux Recalls NUCLISENS Lysis Buffer Due to pH Electrode Dysfunction

    bioMerieux is recalling NUCLISENS Lysis Buffer, Lot 19040201, because pH electrode dysfunction caused colored eluates and invalid test results.

    Product
    NUCLISENS¿ Lysis Buffer, IVD, REF 200292, 48X2 ML LYS Manufacturer bioMerieux SA 376, Chemin de l'Orme 69280 Marcy-l'Etoile - France - Product Usage: to be used for the release of total nucleic acid from biological specimens.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1385-2020·2020-03-04

    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 scanned data.

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) Reference Number: IEHA564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1388-2020·2020-03-04

    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 5MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA574
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1371-2020·2020-03-04

    Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Misalignment

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

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA356
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1387-2020·2020-03-04

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

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

    Product
    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA566
    Category
    Medical Device
    Distribution
    Distributed nationwide