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.

101–125 of 299

  • ModerateFDA (Devices)·Z-0640-2019·2018-12-26

    Advanced Instruments Recalls GloCyte RBC Reagent Due to QC Failure

    Advanced Instruments, LLC is recalling GloCyte RBC Reagent because high fluorescent counts cause quality control checks to fail, preventing patient sample testing.

    Product
    GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0385-2019·2018-11-14

    CareFusion Recalls Alaris Infusion Pump Administration Sets Due to Priming Issues

    CareFusion 303, Inc. is recalling Alaris Infusion Pump administration sets because users reported being unable to prime the devices.

    Product
    Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FITMENT ON PUMP SEGMENT IS OPEN, Fluid path is STERILE and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0119-2019·2018-10-24

    Cypress Medical Recalls McKesson Insulin Syringes Due to Suction Defect

    Cypress Medical Products LLC is recalling 400 cases of McKesson Insulin Syringes because a small hole impedes liquid suction.

    Product
    McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0036-2019·2018-10-10

    Oridion CapnoStream 20 Bedside Patient Monitor Recall for Settings Reset

    Oridion Medical is recalling 245 CapnoStream 20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20 (INTL) N, Part Number CS08652
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0028-2019·2018-10-10

    Oridion Capnostream20 Bedside Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling 769 Capnostream20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) M, Part Number CS08653
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0022-2019·2018-10-10

    Oridion Medical CAPNOSTREAM 20P Patient Monitor Recall for Settings Reset

    Oridion Medical is recalling CAPNOSTREAM 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0042-2019·2018-10-10

    Oridion Medical CAPNOSTREAM 20P Monitors Recalled for Settings Reset

    Oridion Medical is recalling CAPNOSTREAM 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3064-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Issue

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 440 mm, Item Number: 814311440
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-3022-2018·2018-09-19

    ev3 TurboHawk Peripheral Plaque Excision System Recall for Incompatible Accessories

    Micro Therapeutics is recalling 67 units of the ev3 TurboHawk Peripheral Plaque Excision System because packaged accessories are incompatible with the catheter, potentially preventing the removal of excised material.

    Product
    ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2924-2018·2018-09-05

    Stryker Mako Vizadisc Knee Procedure Tracking Kit Recalled for Detection Issues

    Mako Surgical Corporation is recalling specific lots of the Stryker Mako Vizadisc Knee Procedure Tracking Kit because the reflective material may be damaged, preventing camera detection.

    Product
    Stryker Mako Vizadisc Knee Procedure Tracking Kit
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-2945-2018·2018-09-05

    Ceterix Disposable Knot Pusher Recalled for High Cut Force

    Ceterix Orthopedics is recalling 96 units of the Disposable Knot Pusher / Suture Cutter because nonconforming blades may require higher than specified cut force.

    Product
    Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2489-2018·2018-07-25

    Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect

    Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.

    Product
    Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no Probe, Ref ASC1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2493-2018·2018-07-25

    Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect

    Cardinal Health is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.

    Product
    Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Double Spike, Ref ASU1211, packaged 1/box, 12 boxes/case, single use, RX, Sterile. Manufactured For Cardinal Health, Waukegan, IL.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2381-2018·2018-07-18

    Intuitive Surgical Recalls da Vinci Xi Stapler Reloads Due to Missing Component

    Intuitive Surgical is recalling da Vinci Xi Stapler 45 Reloads because a missing knife mechanism component may prevent the device from cutting tissue during surgery.

    Product
    da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2387-2018·2018-07-18

    GE Medical Systems Recalls Innova IGS Fluoroscopic X-ray Systems

    GE Medical Systems is recalling 102 Innova IGS fluoroscopic X-ray systems due to a defect that may cause X-ray abort errors, resulting in the loss of imaging mode during use.

    Product
    Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2388-2018·2018-07-18

    GE Medical Systems Recalls Discovery IGS 740 X-ray Systems

    GE Medical Systems is recalling 102 Discovery IGS 740 systems because X-ray abort errors may cause loss of imaging mode during fluoroscopic use.

    Product
    Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2376-2018·2018-07-11

    Implant Direct Sybron Recalls Out-of-Specification Dental Abutments

    Implant Direct Sybron is recalling 60 REPLANT 5.0mmD Abutments because they are out of specification and cannot be properly fitted to implants.

    Product
    REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2062-2018·2018-06-13

    Siemens ADVIA Chemistry Urea Nitrogen Reagent Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Urea Nitrogen Reagent due to increased calibration failures that prevent the system from generating results.

    Product
    ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2054-2018·2018-06-13

    Siemens ADVIA Centaur TSH3-Ultra Assay Recalled for Analyzer Compatibility Issues

    Siemens is recalling specific lots of ADVIA Centaur TSH3-Ultra assays because they may cause reduced dilution recovery or inoperability when used with Multi-Diluent 15 on certain analyzers.

    Product
    ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-1353-2018·2018-04-18

    Certified Safety Mfg Recalls First Aid Kits with Leaking Honeywell Eyewash

    Certified Safety Mfg Inc is recalling 748 first aid and emergency kits containing Honeywell eyewash due to leaking bottles. The affected units were distributed nationwide.

    Product
    First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash# Size: Honeywell Part# K206125 LXXV - 75V " Economy Cabinet 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K 206154 LXXV - 75V " Deluxe Cabinet ¿3 Shelf RS08016 Eye…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0608-2018·2018-02-21

    Keystone Dental Recalls Multi-Unit Abutments Due to Screw Fit Issues

    Keystone Dental Inc is recalling 20 units of Multi-Unit Abutments because they are unable to accept the final abutment screw.

    Product
    Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or…
    Category
    Medical Device
    Distribution
    Distributed nationwide