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.

Filters

Agency

Category

Minimum severity

Clear filters

17801–17825 of 40124

  • ModerateFDA (Devices)·Z-1566-2020·2020-04-01

    Cook Inc. Recalls Spectrum Central Venous Catheter Trays Due to Incorrect Expiration Dates

    Cook Inc. is recalling 25 Spectrum Central Venous Catheter Trays because the printed expiration dates are incorrect. The devices were distributed to seven US states and Canada.

    Product
    Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1568-2020·2020-04-01

    Signature Orthopaedics Recalls Mislabeled Encina HA Femoral Stem Components

    Signature Orthopaedics is recalling five mislabeled Encina HA Femoral Stem components. The packaging error could cause surgical delays if the wrong product is used.

    Product
    Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip Replacement System Only, CEMENTLESS, UDI: (01) 00841176102934
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1574-2020·2020-04-01

    Bard Groshong Dual-Lumen Catheters Recalled for Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 650 Groshong 9.5 Dual-Lumen CV Catheters because they may contain an incorrect tunneler barb tip, potentially prolonging surgical operations.

    Product
    1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570; 2. Groshong 9.5 F Dual-Lumen CV Catheter, REF: 7726954, UDI: (01)00801741041587
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1576-2020·2020-04-01

    BardPort M.R.I. Implantable Port Recall Due to Incorrect Catheter Tip

    Bard Peripheral Vascular Inc is recalling BardPort M.R.I. Implantable Ports because they may contain an incorrect catheter tip, potentially prolonging surgical operations.

    Product
    BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680, UDI:(01)00801741025679 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1538-2020·2020-04-01

    Siemens ADVIA Chemistry Direct Bilirubin Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Direct Bilirubin assays because they may show positive bias in patients taking eltrombopag.

    Product
    ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1542-2020·2020-04-01

    T.A.G. Medical Recalls FlipCutter III Drills Due to Sterile Barrier Risk

    T.A.G. Medical Products is recalling 6,625 FlipCutter III Drills because cracked blister trays may compromise the sterile barrier, posing a risk of particulate contamination.

    Product
    FlipCutter III Drill
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1533-2020·2020-04-01

    Medtronic Open Pivot Aortic Valve Graft Box Labeling Error Recall

    Medtronic is recalling two Open Pivot Aortic Valve Grafts because the outer box was mislabeled as Aortic while the device was Mitral.

    Product
    Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1575-2020·2020-04-01

    BardPort Titanium Implantable Port Recall Due to Incorrect Catheter Tip

    Bard Peripheral Vascular Inc is recalling 360 BardPort Titanium Implantable Ports because they may contain an incorrect catheter tip, potentially prolonging surgery.

    Product
    BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter , REF: 0602230, UDI: (01)00801741025563 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1579-2020·2020-04-01

    Bard PowerFlow Apheresis IV Port Recalled for Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 296 PowerFlow Implatable Apheresis IV Ports because they may contain an incorrect tunneler tip, potentially prolonging surgical operations.

    Product
    PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended Single-Lumen Venous Catheter, Ref A710962, UDI:(01)00801741129438 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1537-2020·2020-04-01

    Siemens Atellica CH Total Bilirubin Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling Atellica CH Total Bilirubin assays because they may show inaccurate high results for patients taking eltrombopag.

    Product
    Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1540-2020·2020-04-01

    Siemens Total Bilirubin Reagent Cartridge Recall for Eltrombopag Interference

    Siemens Healthcare is recalling Dimension Total Bilirubin Flex reagent cartridges because the assay may show falsely high results for patients taking eltrombopag.

    Product
    Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the ¿ clinical chemistry syst6em is an in vitro diagnostic test intended to quantitatively measure total…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1544-2020·2020-04-01

    Medline Stick Sponge Presaturated W/PVP Recalled for Packaging Seal Voids

    Medline is recalling Stick Sponge Presaturated W/PVP units due to packaging seal voids that compromise sterility.

    Product
    Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1536-2020·2020-04-01

    Siemens Atellica CH Direct Bilirubin Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling Atellica CH Direct Bilirubin assays because they may show inaccurate results for patients taking eltrombopag.

    Product
    Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1573-2020·2020-04-01

    Bard Vaccess CT Implantable Port Recall Due to Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 598 Vaccess CT Power-Injectable Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.

    Product
    1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 7496000, UDI:(01)00801741027482 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1571-2020·2020-04-01

    Bard PowerPort M.R.I. Implantable Port Catheter Recall for Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 878 PowerPort M.R.I. Implantable Port catheters because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.

    Product
    1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, REF: 1809600, UDI: (01)00801741027130 ; 2. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter Without Suture…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1577-2020·2020-04-01

    BardPort M.R.I. Hard Base Implantable Port Recall Due to Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 151 BardPort M.R.I. Hard Base Implantable Ports because they may contain an incorrect tunneler barb tip, potentially prolonging surgical operations.

    Product
    BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter, Ref: 0604550, UDI: (01)00801741025860 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1529-2020·2020-04-01

    Fresenius Medical Care Recalls Honeywell Pressure Transducers for Hemodialysis Systems

    Fresenius Medical Care is recalling 3,561 Honeywell pressure transducers used in hemodialysis delivery systems due to lower long-term reliability.

    Product
    Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE STAR; 2008K2, Common Name: Hemodialysis Delivery Equipment; 2008K@home, Common Name: Hemodialysis Delivery System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1539-2020·2020-04-01

    Siemens ADVIA Chemistry Total Bilirubin Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Total Bilirubin assays because they may show falsely high results for patients taking eltrombopag.

    Product
    ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma of adults and neonates on the ADVIA¿ Chemistry…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1578-2020·2020-04-01

    Bard X-Port isp MRI Implantable Port Recall for Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 225 X-Port isp MRI Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.

    Product
    1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195 2. X-Port isp M.R.I. Implantable Port, with Attachable 9.6F Open-Ended Single-Lumen Venous Catheter, REF: 0657525, UDI:(01)00801741026379…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1547-2020·2020-04-01

    Randox Chemistry QC Premium Plus Recalled for Incorrect Sodium Values

    Randox Laboratories is recalling Chemistry QC Premium Plus due to incorrect Sodium target values. The error affects quality control accuracy for diagnostic assays.

    Product
    Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1541-2020·2020-04-01

    Siemens Dimension Vista Total Bilirubin Reagent Cartridge Recall

    Siemens Healthcare Diagnostics is recalling Dimension Vista Total Bilirubin reagent cartridges because they may produce inaccurate results for patients taking eltrombopag.

    Product
    Dimension Vista¿ Total Bilirubin Flex¿ reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10445146 Product Usage: Dimension Vista TBIL method is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1597-2020·2020-04-01

    Elekta MOSAIQ Oncology Software Recalled for Unit Labeling Error

    Elekta Impac Software is recalling MOSAIQ oncology software because users may enter metric values into fields labeled with US standard units.

    Product
    MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1534-2020·2020-04-01

    bioMerieux Recalls VITEK 2 AST-N371 Cards Due to Compromised Seals

    bioMerieux is recalling 4,130 kits of VITEK 2 AST-N371 cards because compromised top seals may allow moisture to enter, potentially affecting antibiotic performance.

    Product
    VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1599-2020·2020-04-01

    Siemens Atellica CH Ethyl Alcohol Assay Recalled for Calibration Bias

    Siemens Healthcare Diagnostics is recalling Atellica CH Ethyl Alcohol assays due to potential positive bias in results within the 10-day calibration interval.

    Product
    Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1552-2020·2020-04-01

    Quidel Triage TOX Drug Screen Control 1 Kit Recall for Chip Error

    Quidel is recalling Triage TOX Drug Screen Control 1 kits due to a programming error in the control chip that causes false failing results for AMP and mAMP tests.

    Product
    Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, CA 92121 USA Quidel.com
    Category
    Medical Device
    Distribution
    19 states