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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27026–27050 of 27681

  • HighFDA (Devices)·Z-0370-2013·2012-11-28

    NuVasive Recalls 5.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 40mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0422-2013·2012-11-28

    King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Issues

    King Systems Corp. is recalling specific lots of KING LAD Standard ClearSeal laryngeal airway devices because the ethylene oxide sterilization indicators did not change color as expected.

    Product
    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0381-2013·2012-11-28

    Stryker Mantis Torque Wrench Recalled for Hex Tip Fracture

    Stryker Spine is recalling 19 Mantis Torque Wrenches because the hex tip may fracture during use. The recall covers units distributed in the US and internationally.

    Product
    Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0350-2013·2012-11-28

    NuVasive Recalls 5.5mm Cannulated Screw Shank Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 35mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0380-2013·2012-11-28

    Stryker XIA 3 Torque Wrench Recalled Due to Hex Tip Fracture

    Stryker Spine is recalling 54 XIA 3 Torque Wrenches because the hex tip may fracture during use, posing a risk of injury to patients or providers.

    Product
    Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0356-2013·2012-11-28

    NuVasive Recalls 6.5mm Cannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.5mm x 35mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0198-2013·2012-11-28

    GE Healthcare Recalls Mobile Radiographic Imaging Systems Due to Firmware Issue

    GE Healthcare is recalling specific mobile radiographic imaging systems due to a firmware issue affecting technique accuracy as mandated by regulations.

    Product
    GE Healthcare Optima XR 220amx Mobile general purpose radiographic imaging of the human head and body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2013·2012-11-28

    King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Failure

    King Systems Corp. is recalling 2,630 laryngeal airway devices because sterilization indicators failed to change color, suggesting the devices may not be sterile.

    Product
    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0434-2013·2012-11-28

    SenTec V-Sign Membrane Changer Insert Recalled for Manufacturing Defect

    Sentec AG is recalling SenTec V-Sign Membrane Changer Inserts due to a manufacturing defect that prevents electrolyte presence, potentially degrading PCO2 sensor performance.

    Product
    SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0377-2013·2012-11-28

    NuVasive Recalls 7.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 7.5mm x 45mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0424-2013·2012-11-28

    King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Issues

    King Systems Corp. is recalling specific lots of Laryngeal Airway Devices because sterilization indicators failed to change color as expected, potentially indicating improper sterilization.

    Product
    KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0433-2013·2012-11-28

    SenTec V-Sign Membrane Changer Recalled for Manufacturing Defect

    Sentec AG is recalling 195 boxes of SenTec V-Sign Membrane Changers due to a manufacturing defect that prevents electrolyte presence, potentially degrading PCO2 performance.

    Product
    SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0401-2013·2012-11-28

    Kerr Recalls BioPlant Dental Bone Grafting Material Due to Ossification Delay

    Kerr Corporation is recalling BioPlant dental bone grafting material because disturbing the product may halt or delay the ossification process.

    Product
    BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0346-2013·2012-11-28

    Beckman Coulter Recalls UniCel Dxl 600 Access Immunoassay Systems

    Beckman Coulter is recalling 432 UniCel Dxl 600 Access Immunoassay Systems due to confirmed field modifications to probe assemblies.

    Product
    UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0405-2013·2012-11-28

    Carl Zeiss Meditec Recalls INTRABEAM Balloon Applicator Sets Due to Manufacturing Defect

    Carl Zeiss Meditec is recalling 36 INTRABEAM Balloon Applicator Sets because a manufacturing defect could cause a small tube to become dislodged.

    Product
    INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0431-2013·2012-11-28

    Stryker Orthobiologics Recalls Vita Plasma Separator Components

    Stryker Orthobiologics is recalling 3,268 units of the Vita Plasma Separator due to a risk of blood displacement during use.

    Product
    Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0413-2013·2012-11-28

    Captiva Spine Recalls CapLOX II Final Torque Driver Due to Premature Breakage

    Captiva Spine is recalling 10 units of the CapLOX II Final Torque Driver because the device may break prematurely during use.

    Product
    CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0388-2013·2012-11-28

    Stryker Recalls 6.5mm Cancellous Bone Screws Due to Packaging Mix-Up

    Stryker is recalling 6.5mm Cancellous Bone Screws because packaging may contain the wrong screw length, potentially leading to incorrect surgical fixation.

    Product
    Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0347-2013·2012-11-28

    Beckman Coulter Recalls UniCel DxC Immunoassay Systems Due to Field Modifications

    Beckman Coulter is recalling UniCel DxC and Dxl Immunoassay Systems because field modifications were made to the aspirate and dispense probe assemblies.

    Product
    UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0430-2013·2012-11-28

    Biomerieux Recalls 0.9% Sodium Chloride Injections for VITEK 2 System Use

    Biomerieux Inc is recalling 0.9% Sodium Chloride Injections that were distributed as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system.

    Product
    0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users to prepare inoculum with 0.45%-0.50% sodium chloride…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0417-2013·2012-11-28

    SpineFrontier Recalls S-Lift Implant Guides Due to Over-insertion Risk

    SpineFrontier, Inc. is recalling 19 units of S-Lift Implant Guides because using them without stops may allow over-insertion, potentially causing patient injury.

    Product
    S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0344-2013·2012-11-28

    Extremity Medical Recalls IO Fix IntraOsseous Fixation System Due to Screw Failure

    Extremity Medical LLC is recalling 120 units of the IO Fix IntraOsseous Fixation System because product event reports indicate lag screws may pass through washers during surgery.

    Product
    IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0372-2013·2012-11-28

    NuVasive Recalls 5.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 5.5mm x 50mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0406-2013·2012-11-28

    INTRABEAM Balloon Applicator Set Recalled for Manufacturing Defect

    Carl Zeiss Meditec is recalling INTRABEAM Balloon Applicator Sets due to a manufacturing defect that could cause a small tube to become dislodged.

    Product
    INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0410-2013·2012-11-28

    Zimmer Recalls Multipolar Bipolar Cup Liners Due to Assembly Error

    Zimmer, Inc. is removing 195 Multipolar Bipolar Cup Liners because the split poly ring was incorrectly assembled. The recall covers units distributed in the US and several international countries.

    Product
    Multipolar¿ Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usage: The liner snaps into the Multipolar¿ Bipolar Cup and serves as the articulation surface for the femoral head. The split poly locking ring helps contain the head within the liner and also provides a…
    Category
    Medical Device
    Distribution
    Distributed nationwide