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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30676–30700 of 40449

  • HighFDA (Devices)·Z-1213-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Aplicare Castile Soap towelettes found in medical kits due to bacterial contamination.

    Product
    Covidien Dover P400 PREM UM 16FR SILV TMP CSD Item Code: P4P16XTSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1206-2016·2016-03-30

    Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits

    Covidien LLC is recalling Castile soap towelettes found in Foley trays and midstream specimen kits due to bacterial contamination.

    Product
    Covidien Dover PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1199-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Castile soap towelettes in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1195-2016·2016-03-30

    Arthrex Recalls IBalance TKA Tibial Trays Due to Surface Texture Defect

    Arthrex, Inc. is recalling 2,378 IBalance TKA Tibial Trays because the outer metal surface is smooth instead of textured. The devices were distributed nationwide.

    Product
    Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1191-2016·2016-03-30

    Intuitive Surgical Recalls da Vinci Surgeon Side Console Touchpads

    Intuitive Surgical is recalling 542 da Vinci Si and Xi Surgeon Side Console touchpads due to a Class II defect. The recall covers units distributed in the US and 33 other countries.

    Product
    da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The system can also be employed with adjunctive mediastinotomy to perform coronary…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1197-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Castile soap towelettes used in Foley trays and specimen kits because they are contaminated with bacteria.

    Product
    Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL Item Code: 24015 Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1221-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Castile soap towelettes in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD ¿ ¿¿ Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1215-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    The FDA is recalling Castile soap towelettes included in Foley trays and specimen kits because they are contaminated with bacteria.

    Product
    Covidien Dover P400 UM 18FR SIL COUDE SECURE Item Code: P4P18CSDK Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    Aplicare Castile Soap towelettes included in Foley Trays and Mid stream specimen kits are being recalled because they are contaminated with bacteria.

    Product
    Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code: P4P18CSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1245-2016·2016-03-30

    Nidek RT-5100 and RT-3100 Refractors Recalled for Arm Malfunction

    Nidek Inc is recalling RT-5100 and RT-3100 refractors because the Near Point Chart Arm may lower spontaneously, posing a risk of slight injury to the patient's face or nose.

    Product
    RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    Covidien LLC is recalling Castile soap towelettes used in Foley trays and specimen kits because they are contaminated with bacteria.

    Product
    Covidien Dover PREC PRM 18FR SILVER FLY TY Item Code: PP18XSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1208-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    FDA is recalling Aplicare Castile Soap towelettes found in Foley trays and specimen kits because they are contaminated with bacteria.

    Product
    Covidien Dover P400 UM 16FR SIL COUDE SECURE Item Code: P4P16CSDK Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2016·2016-03-30

    Castile Soap Towelettes Recalled Due to Bacterial Contamination

    The FDA is recalling Aplicare Castile Soap towelettes found in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item Code: P4P16TSD Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1192-2016·2016-03-30

    QiG Group Recalls Algovita Implanted Pulse Generators Due to Connection Issues

    QiG Group LLC is recalling 40 Algovita Implanted Pulse Generators because they may fail to connect to external devices unless held very close.

    Product
    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1204-2016·2016-03-30

    Recall of Bacteria-Contaminated Castile Soap Towelettes in Medical Kits

    FDA is recalling Aplicare Castile Soap towelettes found in Foley trays and specimen kits due to bacterial contamination.

    Product
    Covidien Dover PREM U/M 14FR SIL FLY Item Code: P4P14SD P400 Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1202-2016·2016-03-30

    Recall of Contaminated Castile Soap Towelettes in Medical Kits

    FDA is recalling specific lots of Castile soap towelettes used in medical kits due to bacterial contamination.

    Product
    Covidien Dover MIDSTREAM KIT RING CASTILE Item Code: 4090SA Castile soap towelettes are used to clean the genital area for male and female patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1239-2016·2016-03-30

    CareFusion Recalls Alaris PC Infusion Pump Units Due to Power Supply Error

    CareFusion is recalling 170 Alaris PC Unit Infusion Pump Model 8000 devices because a power supply component may cause system error codes.

    Product
    Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1175-2016·2016-03-30

    Toshiba DRAD-3000E Wireless System Recalled for Image Transmission Failure

    Toshiba is recalling 28 DRAD-3000E FPD Wireless Systems because they fail to complete image transmission, resulting in no radiographic image.

    Product
    Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1243-2016·2016-03-30

    Siemens IMMULITE 2000 Estradiol Test Recalled Due to Faslodex Interference

    Siemens Healthcare Diagnostics is recalling IMMULITE 2000 Estradiol Test kits because the drug fulvestrant (Faslodex) may cause falsely elevated estradiol results.

    Product
    IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10381177, 10702834 Product Usage: For in vitro diagnostic use the IMMULITE¿2000 systems Analyzers- for the quantitative measurement of estradiol in serum, as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1189-2016·2016-03-30

    Zimmer Spine Universal Clamp System Recall for Updated Cleaning Instructions

    Zimmer Spine is issuing a correction notice for the Universal Clamp System to provide updated cleaning and disinfecting instructions.

    Product
    Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1233-2016·2016-03-30

    Roche cobas p 512 Pre-analytical System Recalled for Sample Spillage

    Roche is recalling 35 cobas p 512 pre-analytical systems because a sensor defect causes open sample tubes to drop and spill.

    Product
    cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1234-2016·2016-03-30

    Medtronic Recalls BioTex Reusable Adapter Kits Lacking FDA Clearance

    Medtronic Navigation is recalling four BioTex Reusable Adapter Kits because they were distributed without FDA 510(k) clearance.

    Product
    BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned…
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1235-2016·2016-03-30

    AcuFocus Recalls KAMRA Corneal Inlays Due to Shelf Life Labeling Concerns

    AcuFocus is recalling 182 KAMRA ACI 7000 Corneal Inlays because of concerns regarding the labeled shelf life. The devices were distributed in Canada, Germany, Saudi Arabia, Turkey, and the United Kingdom.

    Product
    KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1232-2016·2016-03-30

    Siemens syngo X Workplace Medical Workstation Recalled for Segmentation Error

    Siemens Medical Solutions USA is recalling six syngo X Workplace medical workstations because imported segmentation results appear mirrored, rendering them unusable for ablation procedures.

    Product
    syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1240-2016·2016-03-30

    Siemens Estradiol Test Recalled Due to Potential False Results

    Siemens is recalling ADVIA Centaur Enhance Estradiol tests because the drug fulvestrant may cause falsely elevated results.

    Product
    Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur¿, ADVIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide