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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30601–30625 of 40325

  • 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
  • ModerateFDA (Devices)·Z-1190-2016·2016-03-30

    Zimmer Biomet Issues Correction Notice for Instinct Java System Cleaning Instructions

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

    Product
    Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1237-2016·2016-03-30

    Cook Medical Recalls Nephrostomy Balloon Sets Due to Labeling Mix-up

    Cook Medical is voluntarily recalling specific lots of Ultraxx Nephrostomy Balloon Sets and Ascend AQ Ureteral Dilation Balloon Catheter Sets because of a labeling mix-up.

    Product
    UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1247-2016·2016-03-30

    Neurotherm Curved Radiofrequency Cannula Recalled for Mislabeling

    Neurotherm, Inc. is recalling 135 curved radiofrequency cannulas because straight needles were incorrectly labeled as curved.

    Product
    Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model Number: C-1010-R-18 Product Usage: The device is a radiofrequency needle, used for the application of radiofrequency energy with as intended result, thermo coagulation of nervous tissue…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1238-2016·2016-03-30

    Cook Medical Recalls Ureteral Balloon Catheters Due to Labeling Mix-Up

    Cook Medical is voluntarily recalling specific lots of Ascend AQ Ureteral Dilation Balloon Catheter Sets and Ultraxx Nephrostomy Balloon Sets due to a labeling error where packages may contain the wrong product.

    Product
    Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set is used for transluminal dilation of ureteral…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1244-2016·2016-03-30

    MHI-TM2000 Linear Accelerator Software Recall for Treatment Status Error

    Mitsubishi Heavy Industries is recalling MHI-TM2000 Linear Accelerator Systems due to a software anomaly that may incorrectly change a patient's treatment status to 'Untreated'.

    Product
    MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1181-2016·2016-03-23

    Puritan Bennett 980 Ventilator Recalled for Touchscreen and Ventilation Issues

    Medtronic is recalling 1,864 Puritan Bennett 980 ventilators worldwide due to unresponsive touchscreens and potential loss of primary ventilation.

    Product
    Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1185-2016·2016-03-23

    Stryker Recalls 36 Non-Powered Stretchers Due to Hydraulic Jack Assembly Defect

    Stryker is recalling 36 non-powered stretchers because hydraulic jack assemblies were manufactured with incorrect oil, increasing the risk of leaks or jack drift.

    Product
    Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stretcher
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1148-2016·2016-03-23

    Zimmer NexGen MIS Tibia Plate Recall for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling NexGen MIS Tibia Plates due to insufficient sealer calibration data, raising concerns about the sterility of the devices.

    Product
    Product 50 consists of all product under product code: JWH and same usage: Item no: 595002701 NEXGEN MIS TIBIA PLATE PR 595002702 NEXGEN MIS TIBIA PLATE PR 595003701 NEXGEN MIS TIBIA PLATE PR 595003702 NEXGEN MIS TIBIA PLATE PR 595003712 NEXGEN MIS TIBIA PLATE PR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1161-2016·2016-03-23

    Zimmer Manufacturing Recalls Trilogy Acet Shells Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling 2,063 units of Trilogy Acet Shells used in total hip arthroplasty due to insufficient sealer calibration data.

    Product
    Product 63 consists of all product under product code: LPH and same usage: Item no: 620004020 TRILOGY ACET SHELL 40MM O 620004220 TRILOGY ACET SHELL 42MM O 620004420 TRILOGY ACET SHELL 44MM O 620004620 TRILOGY ACET SHELL 46MM O 620004621 TRILOGY ACET SHELL 46MM O…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1101-2016·2016-03-23

    Zimmer Manufacturing Recalls Unipolar Femoral Heads Due to Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 2,239 unipolar femoral heads used in hip arthroplasty due to insufficient sealer calibration data, raising concerns about the sterility of the devices.

    Product
    Product 3 consists of all products under product code JDI, and same usage: Item no:781803800 12/14 UNIPOLAR FEMORAL HE 781804000 12/14 UNIPOLAR FEMORAL HE 781804100 12/14 UNIPOLAR FEMORAL HE 781804200 12/14 UNIPOLAR FEMORAL HE 781804300 12/14 UNIPOLAR FEMORAL HE 781804400…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1133-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Knee Fluted Rods Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 49 units of sterile I/B II Knee Fluted Rods due to insufficient sealer calibration data.

    Product
    Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 for use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2016·2016-03-23

    Zimmer Manufacturing Recalls Hip Femoral Heads Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling 35,032 hip femoral heads due to insufficient sealer calibration data. The affected sterile products were packaged between August 2010 and April 2013.

    Product
    Product 2 consists of all products product code LPH, and same usage: 801802202 12/14 COCR FEMORAL HEAD 2 801802220 12/14 COCR FEMORAL HEAD 2 801802230 12/14 COCR FEMORAL HEAD 2 801802601 12/14 COCR FEMORAL HEAD 2 801802602 12/14 COCR FEMORAL HEAD 2 801802603 12/14 COCR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1179-2016·2016-03-23

    CareFusion Recalls Alaris VersaSafe Infusion Sets Due to Leakage

    CareFusion is recalling 5,760 Alaris VersaSafe Infusion Sets distributed in Michigan because the split septum port may separate or leak.

    Product
    Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1126-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Femoral Hip Implant Components

    Zimmer Manufacturing B.V. is recalling specific sterile femoral hip implant components due to insufficient sealer calibration data.

    Product
    Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FEMORAL HD 28MM SHORT 32902604035 FEMORAL HD 28MM SHT+ 3.5M For use in total or hemi hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide