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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30701–30725 of 40449

  • 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
  • HighFDA (Devices)·Z-1172-2016·2016-03-23

    Roche Recalls Accu-Chek Inform II Base Units Due to Data Loss Risk

    Roche is recalling Accu-Chek Inform II Base Units because they may lose data or mismatch patient records when connected to specific Data Management Systems.

    Product
    Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1137-2016·2016-03-23

    Zimmer Ion Implanted Femoral Stems Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 17 ion implanted femoral stems used in hip arthroplasty due to insufficient sealer calibration data affecting sterility.

    Product
    Product 39 consists of all product under product code: JDI and same usage: Item no: 32902605800 ION IMPLANTED FEM 22MM LO 32902604900 ION IMPLANTED FEM 26MM ME 32902603900 ION IMPLANTED FEM 26MM SH For use in total or hemi hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1094-2016·2016-03-23

    Pro-Dex Recalls Sterile Battery Packs for Surgical Screwdrivers

    Pro-Dex Inc is recalling sterile battery packs for the KLS Martin Max Driver because they may contain particulates within the sterile package.

    Product
    Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1176-2016·2016-03-23

    CHG Hospital Beds Recalls Spirit Select Beds Due to Alarm Defect

    CHG Hospital Beds is recalling 1,892 Spirit Select beds because the bed exit alarm may fail to function, potentially delaying assistance after a patient fall.

    Product
    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1174-2016·2016-03-23

    Cordis Avanti Catheter Sheath Introducer System Recalled for Incorrect Cannula Size

    Cordis Corporation is recalling 1,985 units of the Avanti Catheter Sheath Introducer System because the cannula is smaller than intended.

    Product
    CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1129-2016·2016-03-23

    Zimmer Free-Lock Tube and SCP Plate Recall for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 285 units of Free-Lock Tube & SCP Plate devices due to insufficient sealer calibration data affecting sterility.

    Product
    Product 31 consists of all product under product code: KTT and same usage: Item no: 118113003 FREE-LOCK TUBE & SCP PLAT 118113502 FREE-LOCK TUBE & SCP PLAT 118113503 FREE-LOCK TUBE & SCP PLAT 118114002 FREE-LOCK TUBE & SCP PLAT 118114003 FREE-LOCK TUBE & SCP PLAT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1182-2016·2016-03-23

    McKesson Medical Imaging Software Recalled for Potential Image Display Errors

    McKesson is recalling Horizon Medical Imaging and Radiology software due to a design deficiency that may cause incorrect patient images to be displayed.

    Product
    McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1150-2016·2016-03-23

    Zimmer NexGen Osteotomy Cortical Bone Screws Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling NexGen Osteotomy Cortical Bone Screws due to insufficient sealer calibration data, raising concerns about the sterility of the devices.

    Product
    Product 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY CORT BON 525004540 NEXGEN OSTEOTOMY CORT BON 525006545 NEXGEN OSTEOTOMY CORT BON 525006560 NEXGEN OSTEOTOMY CORT BON 525006565 NEXGEN OSTEOTOMY CORT BON for use in total knee…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1164-2016·2016-03-23

    Zimmer Versys Advocate Hip Implants Recalled for Calibration Issues

    Zimmer Manufacturing B.V. is recalling Versys Advocate hip implants due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 66 consists of all product under product code: JDI and same usage: Item no: 785001100 VERSYS ADVOCATE CEMENTED 785001200 VERSYS ADVOCATE CEMENTED 785001220 VERSYS ADVOCATE CEMENTED 785001300 VERSYS ADVOCATE CEMENTED 785001320 VERSYS ADVOCATE CEMENTED 785001400…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2016·2016-03-23

    Deerfield Imaging Recalls Intraoperative MRI Systems Due to Venting Line Defect

    Deerfield Imaging is recalling specific intraoperative MRI systems because emergency helium venting lines may not have been properly installed.

    Product
    Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1110-2016·2016-03-23

    Zimmer Manufacturing Recalls 6 Degree COCR Femoral Heads for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 209 units of 6 Degree COCR Femoral Heads due to insufficient sealer calibration data. The affected sterile products were distributed nationwide in the US.

    Product
    Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE COCR FEM HEAD 28 902603235 6 DEGREE COCR FEM HEAD 32 902603335 6 DEGREE COCR FEM HEAD 32 902603600 6 DEGREE COCR FEM HEAD 36…
    Category
    Medical Device
    Distribution
    Distributed nationwide