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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14076–14100 of 27500

  • HighFDA (Devices)·Z-1410-2020·2020-03-11

    DeRoyal Sterile Custom Kits Recalled for Unknown Contamination

    DeRoyal Industries is recalling 2,100 sterile custom kits containing Cardinal Health gowns due to unknown bioburden and particulate contamination.

    Product
    DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: Outpatient Major 89-3865.12;
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1444-2020·2020-03-11

    Roche Recalls Elecsys CA 19-9 Reagent Due to Non-Reproducible Results

    Roche Diagnostics is recalling 684 units of Elecsys CA 19-9 reagent because non-reproducible elevated results may affect clinical interpretation.

    Product
    Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1439-2020·2020-03-11

    Vyaire Medical Recalls bellavista 1000 Ventilators Due to Alarm Failures

    Vyaire Medical is recalling 116 bellavista 1000 ventilators because they may fail to sound high-priority alarms or respond to touch screen input.

    Product
    bellavista 1000 ventilator, Catalog number 301.100.030. bellavista is an electronically controlled pneumatic ventilation system with an integrated air compressing system. bellavista uses room air and high-pressure oxygen. Air enters through a fresh gas intake port and is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1360-2020·2020-03-11

    CareFusion Alaris Pump Module Recalled for Software Errors

    CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.

    Product
    CareFusion Alaris Pump Module, Model 8100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1447-2020·2020-03-11

    Recall of Force TriVerse Electrosurgical Kits Due to Sterility Concerns

    Covidien is recalling Force TriVerse Electrosurgical Kits distributed in EMEA due to potential sterile packaging compromise, which may increase infection risk.

    Product
    Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) only. No US distribution. Kits are manufactured in The Netherlands. Item codes BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01 BREASTKIT01…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1409-2020·2020-03-11

    Baxter Recalls Revaclear 300 Dialyzers Due to Potential Foreign Matter

    Baxter Healthcare is recalling Revaclear 300 Capillary Dialyzers because of the potential presence of particular matter in the header caps of ten lots.

    Product
    Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1440-2020·2020-03-11

    Invivo Recalls MRI Monitor Adapters Due to Insufficient Shielding

    Invivo Corporation is recalling 75 SensaVue DVI adapters for MRI monitors because they have insufficient shielding. The units were distributed in the U.S. and several foreign countries.

    Product
    Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1424-2020·2020-03-11

    Beckman Coulter Uric Acid Reagent Recalled for Acetaminophen Interference

    Beckman Coulter is recalling Uric Acid Reagents because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.

    Product
    Uric Acid Reagent (URIC 2 X 300), REF: 442785, For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575281
    Category
    Medical Device
    Distribution
    48 states
  • 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
  • SevereFDA (Devices)·Z-1357-2020·2020-03-04

    Medline Lumbar Delivery System Recalled Due to Sterilization Failure

    Medline Industries is recalling 122 units of HOI Lumbar Complete Delivery Systems because the sterile packs did not complete a sterilization cycle, compromising sterility.

    Product
    Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1402-2020·2020-03-04

    MicroVention HydroFrame 10 Embolic Coils Recalled for Missing Implant Coil

    MicroVention is recalling 991 HydroFrame 10 and HydroCoil embolic systems because the implant coil may be missing. The devices were distributed outside the United States.

    Product
    MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 100306HFRM-V, 100405HFRM-V, 100408HFRM-V, 100410HFRM-V, 100412HFRM-V, 100415HFRM-V, 100510HFRM-V, 100515HFRM-V, 100519HFRM-V, 100612HFRM-V, 100619HFRM-V…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1358-2020·2020-03-04

    Medline Robotic-LF Complete Delivery System Recall Due to Sterility Concerns

    Medline Industries is recalling 122 units of the Robotic-LF Complete Delivery System because the sterile packs did not complete a sterilization cycle, meaning sterility cannot be guaranteed.

    Product
    Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTIN (01)10888277056350
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1346-2020·2020-03-04

    Siemens COHERENCE Oncologist Software Recall for Incorrect Dose Positioning

    Siemens is recalling COHERENCE Oncologist software due to a calculation error that could lead to incorrect patient repositioning and radiation dose delivery to the wrong location.

    Product
    COHERENCE Oncologist, Model Nos. 07333680 & 07351898
    Category
    Medical Device
    Distribution
    16 states
  • 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 (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