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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20051–20075 of 40248

  • ModerateFDA (Devices)·Z-2100-2019·2019-08-14

    ASTRA Lidar System Recalled for Incorrect Class 1 Laser Labeling

    ASTRA, LLC is recalling one Lidar System for Erosion Flume Application due to incorrect labeling of a Class 1 laser product.

    Product
    Lidar System for Erosion Flume Application Class 1 Laser Product Product Usage: Product is installed and fixed above a dynamic indoor flume designed for modeling water erosion in an indoor research environment with limited human access
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2159-2019·2019-08-14

    DRG Salivary Testosterone ELISA Recalled for Inaccurate Low-Range Results

    DRG Instruments GmbH is recalling 38 kits of Salivary Testosterone ELISA because the assay may report testosterone levels that are too low.

    Product
    DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2150-2019·2019-08-14

    Randox Human Assayed Multi-Sera Level 2 Recalled for Incorrect Control Values

    Randox Laboratories is recalling Human Assayed Multi-Sera Level 2 controls due to incorrectly assigned target and range values for specific analytes.

    Product
    Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2195-2019·2019-08-14

    Siemens Lantis 6.1 Commander Recalled for Windows RDP Vulnerability

    Siemens Medical Solutions is recalling two Lantis 6.1 Commander units due to a Microsoft Windows Remote Desktop Protocol vulnerability.

    Product
    Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2194-2019·2019-08-14

    Philips Recalls Vereos PET/CT Systems Due to Image Labeling Error

    Philips is recalling 26 Vereos PET/CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.

    Product
    Vereos PET/CT Model # 882446, computed tomography x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2145-2019·2019-08-14

    Geistlich Bio-Oss Pen Recalled Due to Visible Plastic Debris

    Geistlich Pharma is recalling Bio-Oss Pen applicators because a visible piece of green plastic was found on the outer barrel when unscrewing the cap.

    Product
    Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2188-2019·2019-08-14

    Philips CT System Recall for Incorrect Phase Tolerance Image Labeling

    Philips is recalling Ingenuity Core CT systems because images may be incorrectly labeled as having phase tolerance applied when it was not.

    Product
    Ingenuity Core Model # 728321, computed tomography x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2199-2019·2019-08-14

    Philips Ultrasound Systems Recalled for Patient Data Entry Error

    Philips is recalling EPIQ and Affiniti ultrasound systems with software version 4.0 because patient images may be moved to the wrong folder.

    Product
    Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ CVx, Affiniti 30, Affiniti 50, and Affiniti 70. Product Usage: The intended use of the EPIQ, EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2179-2019·2019-08-14

    Ortho Clinical Diagnostics Recalls VITROS 5600 Integrated System Analyzers

    Ortho Clinical Diagnostics is recalling 2,531 VITROS 5600 Integrated Systems due to a software anomaly that may cause unsuccessful calibration.

    Product
    VITROS 5600 Integrated System, clinical chemistry analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2158-2019·2019-08-14

    Polymer Technology Systems Recalls Mislabeled Lipid Panel Test Strips

    Polymer Technology Systems is recalling 559 vials of IVD Lipid Panel test strips because the accompanying MEMo chips may be mislabeled, potentially causing the analyzer to display the wrong lot number.

    Product
    Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2157-2019·2019-08-14

    PTS Lipid Panel Test Strips Recalled for MEMo Chip Labeling Error

    Polymer Technology Systems is recalling Lipid Panel test strips because the included MEMo chips may display the wrong lot number on the analyzer screen.

    Product
    PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2139-2019·2019-08-14

    Sage Products Recalls Independent Care System Due to Damaged Mouthpaste Tubes

    Sage Products Inc is voluntarily recalling a lot of Independent Care System kits because the included Sodium Bicarbonate Mouthpaste tubes may be cosmetically damaged.

    Product
    Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System. The system is an oral care convenience kit which includes: an Ultra-Soft Toothbrush, 0.5 oz. tube of Mouth Moisturizer, 0.33 oz. /9g tube of Sodium Bicarbonate Mouthpaste…
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2088-2019·2019-08-07

    Qiagen Filter-Tips Recalled for Leaking During Sample Preparation

    Qiagen Sciences LLC is recalling specific lots of Filter-Tips used with QIAsymphony instruments because a small percentage of tips are leaking.

    Product
    Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1956-2019·2019-08-07

    Centurion Recalls Sheridan Endotracheal Tubes for Connector Disconnection

    Centurion Medical Products is recalling 80 Sheridan Endotracheal Tubes due to an increased incidence of the connector becoming disconnected from the tube.

    Product
    Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2104-2019·2019-08-07

    Terumo Capiox NX19 Oxygenator Recalled for Non-Functioning Thermistor

    Terumo is recalling Capiox NX19 Oxygenators because they may contain a non-functioning arterial thermistor component.

    Product
    Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2127-2019·2019-08-07

    Burlington Medical Recalls Radiation Protection Caps Due to Inadequate Shielding

    Burlington Medical is recalling 49 radiation protection caps because the protective material may not adequately shield users from scatter radiation.

    Product
    Cap, Product Number Cap, Part Numbers CAP1, CAP2 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2135-2019·2019-08-07

    Siemens Stratus CS Acute Care cTNI TestPak Recalled for False Positives

    Siemens Healthcare Diagnostics Inc is recalling Stratus CS Acute Care cTNI TestPaks due to a potential for increased false positive results.

    Product
    Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2129-2019·2019-08-07

    Burlington Medical Porta Shield Radiation Protection Recall

    Burlington Medical is recalling Porta Shield radiation protection products because the material may provide inadequate protection against scatter radiation.

    Product
    Porta Shield, Product Number Porta Shield, Part Numbers PTS2, PTS3, PTS4 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2114-2019·2019-08-07

    Burlington Medical Recalls 129 Full Overlap Radiation Protection Vests and Kilts

    Burlington Medical is recalling 129 two-piece radiation protection vests and kilts because the protective material may provide inadequate shielding against scatter radiation.

    Product
    2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, SEFVK*M, SEFVKE, SEFVKXLM Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2126-2019·2019-08-07

    Burlington Medical Recalls Half Aprons Due to Potential Radiation Protection Deficiency

    Burlington Medical is recalling two half aprons because the protective material may provide inadequate protection against scatter radiation, potentially exposing users to higher radiation levels.

    Product
    Half Apron, Product Number Half Apron, Part Numbers REHALF*, REHALF3 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2122-2019·2019-08-07

    Burlington Medical Recalls Thyroid Collars Due to Inadequate Radiation Protection

    Burlington Medical is recalling 807 thyroid collars because the protective material may provide inadequate protection against scatter radiation, potentially increasing long-term health risks.

    Product
    Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-R, RLTS4-SEP, RLTS4-T2T, SBTS4-R, SETS4-T2T, SLTS4-R, UETS4-R Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2128-2019·2019-08-07

    Burlington Medical Recalls Radiation Protection Hoods Due to Inadequate Shielding

    Burlington Medical is recalling three radiation protection hoods because the protective material may not adequately shield users from scatter radiation.

    Product
    Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2124-2019·2019-08-07

    Burlington Medical Recalls Frontal Radiation Protection Aprons Due to Inadequate Shielding

    Burlington Medical is recalling Frontal Aprons with Quick Drop Velcro Closure because the protective material may provide inadequate protection against scatter radiation.

    Product
    Frontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401, Part Numbers RE401*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2090-2019·2019-08-07

    Encore Medical Recalls Flexible Drill Shafts Due to Manufacturing Error

    Encore Medical is recalling 21 Flexible Drill Shafts because a manufacturing error may prevent the shaft from capturing the drill bit pin, potentially causing the bit to come loose during surgery.

    Product
    Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
    Category
    Medical Device
    Distribution
    6 states