The Recall Desk

Hazard

Functional Defect recalls

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

What the numbers show

Total
293
Critical
0
Severe
2
Most recent
2026-08-26

Of the 293 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 2 (1%) 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 293

  • ModerateFDA (Devices)·Z-0317-2014·2013-11-27

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry LIPA Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry LIPA Slides due to slide dispense issues affecting the cartridges used with the product.

    Product
    VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 and packaged as 90 slides/pack catalog number 8297749 VITROS LIPA Slides quantitatively measure Lipase (LIPA) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry
    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 shi
    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 0853
    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-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 085
    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 Plainsb
    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) 4.0
    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 spe
    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 heterogen
    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 a
    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 added
    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 Ca
    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
  • LowFDA (Devices)·Z-1025-2013·2013-04-10

    Viscot Medical Recalls Dual Tip Markers Due to Inconsistent Ink Flow

    Viscot Medical LLC is recalling 458,589 sterile dual tip markers because the black permanent ink side has inconsistent ink flow.

    Product
    Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0922-2013·2013-03-20

    Instratek Recalls Endotrig Trigger Release Blades Due to Cannula Advancement Issues

    Instratek is recalling 235 Endotrig Trigger Release Sterile Micro Hook Blades because they could not be advanced into the cannula during procedures.

    Product
    Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0941-2013·2013-03-20

    Synthes Large Combination Clamp Recalled Due to Oversized Hex Nuts

    Synthes USA is recalling 136 Large Combination Clamps because oversized hex nuts prevent standard 11 mm sockets and wrenches from fitting.

    Product
    Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0738-2013·2013-02-06

    bioMerieux Recalls BacT/ALERT SA Blood Culture Bottles with Uncured Sensors

    bioMerieux, Inc. is recalling BacT/ALERT SA Blood Culture Bottles because some units may contain uncured sensors, potentially affecting the detection of microorganisms.

    Product
    BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0739-2013·2013-02-06

    Becton Dickinson Recalls BBL Fildes Enrichment Tubes for Growth Failure

    Becton Dickinson is recalling BBL Fildes Enrichment tubes because they may fail to support the growth of Haemophilus species, potentially affecting laboratory test results.

    Product
    BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA*** Intended Use: Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms. Fildes Enrichment i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0505-2013·2012-12-19

    ConMed Recalls WANG Transbronchial Aspiration Needles Due to Fit Issues

    ConMed is recalling WANG Transbronchial Aspiration Needles because they may not fit through a 2.0 mm bronchoscope, causing minor inconvenience.

    Product
    WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with
    Category
    Medical Device
    Distribution
    14 states