The Recall Desk

Hazard

Functional Defect recalls

299 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
299
Critical
0
Severe
7
Most recent
2026-10-21

Of the 299 functional defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 7 (2%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all functional defect recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

251–275 of 299

  • ModerateFDA (Devices)·Z-0318-2014·2013-11-27

    Ortho-Clinical Recalls VITROS Chemistry Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges due to slide dispense issues.

    Product
    VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204 VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0325-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Slide Dispense Cartridges

    Ortho-Clinical Diagnostics is recalling VITROS Slide Dispense cartridges due to slide dispense issues affecting VITROS Chemistry Product Slides.

    Product
    VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764 and packaged as 90 slides/pack catalog number 1307164 VITROS THEO Slides quantitatively measure theophylline (THEO) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0292-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS ACET Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products ACET Slides because of slide dispense issues. The recall affects 16,732 units distributed worldwide.

    Product
    VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274 VITROS Chemistry Products ACET Slides quantitatively measure acetaminophen (ACET) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0297-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS AMON Slides for Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS AMON Slides due to slide dispense issues. The recall affects 24,322 units distributed worldwide.

    Product
    VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869 and packaged as 90 slides/pack catalog number 1726926 VITROS AMON Slides quantitatively measure ammonia concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0311-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS dHDL Slides Due to Dispense Issues

    Ortho-Clinical Diagnostics is recalling VITROS dHDL Slides because slide dispense cartridges may cause dispensing problems.

    Product
    VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895 VITROS dHDL Slides quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0293-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product Slides due to slide dispense issues. The recall affects 544 units distributed worldwide.

    Product
    VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 VITROS Chemistry Products AcP Slides quantitatively measure acid phosphatase (AcP) activity in serum and plasma using VITROS 950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0314-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product GLU Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product GLU Slides due to slide dispense issues. The recall affects 349,072 units distributed worldwide.

    Product
    VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number 1707801 VITROS GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0274-2014·2013-11-20

    SpineFrontier Recalls S-LIFT Extension Shims Due to Fit Variation

    SpineFrontier, Inc. is recalling 67 S-LIFT Extension Shims because they may not fit down all retractor blades, potentially interfering with surgical procedures.

    Product
    S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0188-2014·2013-11-20

    Spacelabs elance Vital Signs Monitor Recalled Due to Sensor Connection Failure

    Spacelabs Healthcare is recalling 89 elance Vital Signs Monitors because they cannot connect to Spacelabs TruLink SpO2 sensors.

    Product
    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0058-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because some contain a hex wrench that may not loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0055-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring kits because a hex wrench may fail to loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring; 1 x Dual Lumen Introducer Kit REF IP2; Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0054-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring kits because a hex wrench may fail to loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring; 1 x Complete Brain Probe Kit REF IP1.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0057-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench

    Integra LifeSciences is recalling 109 Licox Brain Tissue Oxygen Monitoring Kits because some contain a hex wrench that may fail to loosen the set screw on the drill bit.

    Product
    Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0056-2014·2013-10-30

    Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Hex Wrench Defect

    Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because some hex wrenches may fail to loosen the set screw on the drill bit.

    Product
    Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0065-2014·2013-10-30

    Varian Medical Recalls Breast Template System Due to Sterilization Defect

    Varian Medical Systems is recalling 3 sets of the VARISOURCE Breast Template System because the templates may bend and turn opaque after steam sterilization.

    Product
    VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 ***Manufacturer: Varian Medical Systems, Inc., 3100 Hansen Way, Palo Alto, CA 94304 USA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2137-2013·2013-09-11

    Boston Scientific Recalls Small Peripheral Cutting Balloon Catheters

    Boston Scientific is recalling 4.0mm x 15mm Small Peripheral Cutting Balloon catheters because users may be unable to remove the protector cap from the device.

    Product
    Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae. 1)…
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2118-2013·2013-09-04

    Ventana BenchMark and Discovery Instruments Recalled for Heating Element Defect

    Ventana Medical Systems is recalling BenchMark and Discovery instruments because a heating element may separate, causing inconsistent staining without an error message.

    Product
    Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1946-2013·2013-08-21

    Stryker Recalls IsoGel AIR 84 Support Surfaces Due to Air Pump Alarm Issues

    Stryker is recalling 586 IsoGel AIR 84 support surfaces because connected air pumps may flash and alarm due to pressure blockages.

    Product
    IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1925-2013·2013-08-14

    Siemens Mass Creatine Kinase MB Isozyme Calibrator Recalled for Dissolution Issues

    Siemens Healthcare Diagnostics is recalling 7,470 units of the Dimension Mass Creatine Kinase MB Isozyme Calibrator because the lyophilized cake may not fully dissolve.

    Product
    Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1933-2013·2013-08-14

    SpineFrontier Recalls Indus Invue Screw Caddies Due to Removal Difficulty

    SpineFrontier, Inc. is recalling Indus Invue Screw Caddies because screws are difficult to remove from the device. The recall affects 13 units distributed in the US and Jamaica.

    Product
    Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1608-2013·2013-07-03

    Cordis RadialSource Spring Wire Transradial Access Kit Recalled for Undersized Tip

    Cordis and Greatbatch Medical are recalling one lot of RadialSource Spring Wire Transradial Access Kits because some units have an undersized vessel dilator tip that cannot slide over the guidewire.

    Product
    Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. Baxter's lnfusors SV…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1242-2013·2013-05-15

    Smiths Medical Recalls Wallace Sure-Pro Embryo Replacement Catheters

    Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro Two Stage Embryo Replacement Catheters because the catheter may fail to pass through the outer sheath during embryo transfer.

    Product
    Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement Catheters have the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1239-2013·2013-05-15

    Smiths Medical Recalls Embryo Replacement Catheters Due to Functional Defect

    Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro and Sure-Pro Ultra Embryo Replacement Catheters because the catheter may fail to pass through the outer sheath during embryo transfer.

    Product
    Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1153-2013·2013-05-01

    Nova StatStrip Xpress Glu-Test Strips Recalled for No Result Messages

    Nova Biomedical is recalling specific lots of Nova StatStrip Xpress Glu-Test Strips because they may display a 'no result' message when tested.

    Product
    Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1076-2013·2013-04-17

    Kerr Maxcem Elite Resin Cement Recalled for Premature Polymerization

    Kerr Corporation is recalling Kerr Maxcem Elite resin cement kits and syringes because raw material causes the product to set prematurely, potentially preventing proper restoration placement.

    Product
    Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations.
    Category
    Medical Device
    Distribution
    Distributed nationwide