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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15326–15350 of 27471

  • HighFDA (Devices)·Z-2393-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling 91 units of GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397310, 14.5F, straight, 31cm length, BARD, UDI: 00801741012327
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2384-2019·2019-09-04

    Bard Hemodialysis Catheter Recalled for Molded Tip Breakage During Placement

    Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during the placement procedure.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393230, 14.5F, Straight, 23cm length, BARD, UDI: 00801741012181
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2394-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling 39 units of GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397350, 14.5F, straight, 35cm length, BARD, UDI: 00801741012334
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2381-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recalled for Tip Defect

    Bard Peripheral Vascular Inc is recalling 2 units of Equistream XK hemodialysis catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913310, 16F, Straight, 31cm length, BARD, UDI: 00801741013867
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2391-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397230, 14.5F, straight, 23cm length, BARD, UDI: 00801741012303
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2376-2019·2019-09-04

    Bard Equistream XK Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling Equistream XK Alphacurve Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product code:5915240, 16F, 24cm length, BARD, UDI: 00801741013904
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2361-2019·2019-09-04

    Roche Elecsys Anti-CCP Immunoassay Recalled Due to Performance Issues

    Roche Diagnostics is recalling specific lots of the Elecsys Anti-CCP Immunoassay due to performance issues when used with plasma samples on certain analyzers.

    Product
    Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Devices)·Z-2369-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling 135 units of Equistream Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905240, 14.5 Fr. Alphacurve Catheter with Standard Kit, 24cm length, BARD, UDI# 00801741013805
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2400-2019·2019-09-04

    Siemens SOMATOM go.Up CT Systems Recalled for Falling Injector Holder

    Siemens is recalling 18 SOMATOM go.Up CT systems because the injector holder could fall off, posing a risk of injury.

    Product
    SOMATOM go.Up; Models #11061620 Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2390-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397190, 14.5F, straight, 19cm length, BARD, UDI: 00801741012297
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2387-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter, REF/Product code:5396190, 14.5F, Alphacurve, 19cm length, BARD, UDI: 00801741012242
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2392-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recall Due to Tip Damage

    Bard Peripheral Vascular Inc is recalling 887 units of GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet, REF/Product code:5397270, 14.5F, straight, 27cm length, BARD, UDI: 00801741012310
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2385-2019·2019-09-04

    Bard GlidePath Hemodialysis Catheter Recalled for Tip Breakage

    Bard Peripheral Vascular Inc is recalling GlidePath Long-Term Hemodialysis Catheters because the molded tip may break or become damaged during placement.

    Product
    GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393270, 14.5F, Straight, 27cm length, BARD, UDI: 00801741012198
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2374-2019·2019-09-04

    Bard Equistream Hemodialysis Catheter Recalled for Molded Tip Defect

    Bard Peripheral Vascular Inc is recalling 13 units of Equistream Long-Term Hemodialysis Catheters because the molded tip may break or be damaged during placement.

    Product
    EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903310, 14.5F, Straight ,31cm length, BARD, UDI: 00801741013720
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2409-2019·2019-09-04

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta is recalling 49 Monaco Radiation Treatment Planning Systems because software errors display and export incorrect anatomy and beam shift directions.

    Product
    Monaco Radiation Treatment Planning System (RTP) System
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Devices)·Z-2226-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems due to reports of burst balloons that caused difficulty retrieving the device during procedures.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-2227-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems because burst balloons can make it difficult to remove the device from patients.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-2295-2019·2019-08-28

    Arcos Burn Navigator H2 Recalled for Battery Fire Risk

    Arcos, Inc. is recalling 28 Burn Navigator H2 units because their battery packs may heat up abnormally and ignite in rare instances.

    Product
    Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2224-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling 362 units of the SAPIEN 3 Ultra Transcatheter Heart Valve System due to reports of burst balloons that complicate device retrieval.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-2225-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems due to reports of burst balloons that caused significant difficulty retrieving the device during procedures.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2308-2019·2019-08-28

    BD Vacutainer Blood Collection Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer LH blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.

    Product
    BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2341-2019·2019-08-28

    Siemens N Cuvette Segments Recalled for Falsely Elevated Albumin Results

    Siemens Healthcare Diagnostics is recalling N Cuvette Segments for the BN ProSpec System because they may produce falsely elevated albumin results.

    Product
    N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2310-2019·2019-08-28

    BD Vacutainer Lithium Heparin Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer LH blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2349-2019·2019-08-28

    Thoratec Heartmate 3 Sealed Outflow Graft Recall for Leak Risk

    Thoratec Corp. is recalling 149 Heartmate 3 Sealed Outflow Graft units because the C-Ring may not seat properly, causing leaks during implantation.

    Product
    Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2294-2019·2019-08-28

    TiSport Recalls TiLite Wheelchair Anti-Tip Tubes for Tipping Risk

    TiSport is recalling 1,452 TiLite wheelchairs because the anti-tip tubes may fail, allowing the chair to tip backwards.

    Product
    TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extension for manual wheelchairs). Product Usage: The affected component is part of a manual wheelchair to provide mobility to…
    Category
    Medical Device
    Distribution
    Distributed nationwide