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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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

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30626–30650 of 40325

  • 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
  • HighFDA (Devices)·Z-1154-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Fixation Screws Due to Sealer Calibration

    Zimmer Manufacturing B.V. is recalling 56 sterile bone fixation screws due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 56 consists of all product under product code: HWC and same usage: Item no: 47234702032 PERI SCR 3.5MM X 32MM STE 47234702018 PERI SCR. 3.5MM X 18MM ST 47234702020 PERI SCR. 3.5MM X 20MM ST 47234702022 PERI SCR. 3.5MM X 22MM ST 47234702026 PERI SCR. 3.5MM X 26MM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1163-2016·2016-03-23

    Zimmer Versa-FX II Keyless Bone Fixation Devices Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 5,538 units of Versa-FX II Keyless bone fixation devices due to insufficient sealer calibration data affecting sterility.

    Product
    Product 65 consists of all product under product code: KTT and same usage: Item no: 119413594 VERSA-FX II KEYLESS SHORT 119413595 VERSA-FX II KEYLESS SHORT 119413596 VERSA-FX II KEYLESS SHORT 119413004 VERSA-FX II KEYLESS TUBE 119413005 VERSA-FX II KEYLESS TUBE 119413006…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2016·2016-03-23

    Zimmer Manufacturing Recalls Free-Lock Lag Screws Due to Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 3,500 units of Free-Lock Lag Screws and related bone fixation products due to insufficient sealer calibration data affecting sterility.

    Product
    Product 30 consists of all product under product code: KTT and same usage: Item no: 118100527 FREE-LOCK LAG SCREW, 12.7 118100535 FREE-LOCK LAG SCREW, 12.7 118100540 FREE-LOCK LAG SCREW, 12.7 118100542 FREE-LOCK LAG SCREW, 12.7 118101022 FREE-LOCK LAG SCREW, 12.7…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1184-2016·2016-03-23

    Stryker Recalls Prime Series Stretchers Due to Hydraulic Jack Oil Error

    Stryker is recalling 36 Prime Series Stretchers because hydraulic jack assemblies were filled with incorrect oil, increasing the risk of leaks or jack drift.

    Product
    Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1169-2016·2016-03-23

    Zimmer Versis Press Fit Hip Components Recalled for Sterility Concerns

    Zimmer Manufacturing B.V. is recalling 2,388 Versis Press Fit hip arthroplasty components due to insufficient sealer calibration data, raising concerns about the sterility of the devices.

    Product
    Product 71 consists of all product under product code: JDI and same usage: Item no: 783401000 VERSYS PRESS FIT LD/FX ST 783401100 VERSYS PRESS FIT LD/FX SZ 783401200 VERSYS PRESS FIT LD/FX SZ 783401300 VERSYS PRESS FIT LD/FX SZ 783401400 VERSYS PRESS FIT LD/FX SZ…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1152-2016·2016-03-23

    Zimmer NexGen Taper Plug Recalled for Insufficient Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling 1,767 NexGen Taper Plugs used in total knee arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 54 consists of all product under product code: JWH and same usage: Item no: 596009900 NEXGEN TAPER PLUG for use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1149-2016·2016-03-23

    Zimmer NexGen Option Stemmed Tibia Recalled for Sterility Concerns

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

    Product
    Product 51 consists of all product under product code: JWH and same usage: Item no: 598603701 NEXGEN OPTION STEMMED TIB 598603702 NEXGEN OPTION STEMMED TIB 598604701 NEXGEN OPTION STEMMED TIB 598604702 NEXGEN OPTION STEMMED TIB 598605701 NEXGEN OPTION STEMMED TIB…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1187-2016·2016-03-23

    Medtronic Recalls Covidien Emprint Percutaneous Antenna Due to Generator Shutdown Risk

    Medtronic is voluntarily recalling specific lots of the Covidien Emprint Percutaneous Antenna because the generator may shut down during high-temperature measurements.

    Product
    Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of units per carton is 1. Long Percutaneous Antenna with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1141-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Intramedullary Nails Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling 1,102 sterile intramedullary nails distributed nationwide. The recall is due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 43 consists of all product under product code: HSB and same usage: Item no: 224001016 M/DN R-F IM NAIL 10MM DIA 224001018 M/DN R-F IM NAIL 10MM DIA 224001020 M/DN R-F IM NAIL 10MM DIA 224001022 M/DN R-F IM NAIL 10MM DIA 224001024 M/DN R-F IM NAIL 10MM DIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1113-2016·2016-03-23

    Zimmer Astel Femoral Head Recall Due to Sealer Calibration Data

    Zimmer Manufacturing B.V. is recalling sterile Astel femoral heads for hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD +10.5X28MM 805002803 ASTEL FEM HEAD +3.5X28MM 805002804 ASTEL FEM HEAD +7X28MM DI 805002801 ASTEL FEM HEAD -3.5X28MM Usage: For use in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1162-2016·2016-03-23

    Zimmer Manufacturing Recalls Unipolar Endo Femoral Heads Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling specific unipolar endo femoral heads used in hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 64 consists of all product under product code: JDI and same usage: Item no: 902605101 UNIPOLAR ENDO FEM HEAD 51MM For use in hemi hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1115-2016·2016-03-23

    Zimmer Manufacturing Recalls Sterile Bone Screws Due to Calibration Issues

    Zimmer Manufacturing B.V. is recalling sterile bone screws used in hip arthroplasty due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 17 consists of all product under product code: LPH and same usage: Item no: 625004515 BONE SCREW 4.5X15 SELF-TA 625004520 BONE SCREW 4.5X20 SELF-TA 625004525 BONE SCREW 4.5X25 SELF-TA 625004530 BONE SCREW 4.5X30 SELF-TA 625004535 BONE SCREW 4.5X35 SELF-TA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1120-2016·2016-03-23

    Zimmer Manufacturing Recalls Hip Arthroplasty Components Due to Sealer Calibration Issues

    Zimmer Manufacturing B.V. is recalling specific hip arthroplasty components due to insufficient sealer calibration data for products packaged between August 2010 and April 2013.

    Product
    Product 22 consists of all product under product code: JDI and same usage: Item no: 811400218 CPT 12/14 COCR REVISION S 811400318 CPT 12/14 COCR REVISION S 811400420 CPT 12/14 COCR REVISION S 811400423 CPT 12/14 COCR REVISION S 811400426 CPT 12/14 COCR REVISION S…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1180-2016·2016-03-23

    Steris Quick Connects Recalled Due to Hysteroscope Port Mismatch

    Steris Corporation is recalling 809 Quick Connect flow units because processing instructions incorrectly list a hysteroscope model with two inlet ports when the device has only one.

    Product
    Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used in endoscope washers.
    Category
    Medical Device
    Distribution
    Distributed nationwide