The Recall Desk

Hazard

Functional Failure recalls

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

What the numbers show

Total
127
Critical
0
Severe
3
Most recent
2026-04-29

Of the 127 functional failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (2%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all functional failure 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.

76–100 of 127

  • ModerateFDA (Devices)·Z-0283-2018·2017-12-27

    Implant Direct Recalls Spectra Guided Surgery Handle Kits for Dimensional Defects

    Implant Direct is recalling 560 Spectra System/Legacy Guided Surgery Handle Kits because some guide inserts do not meet specifications, preventing proper drill passage.

    Product
    Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0281-2018·2017-12-27

    Zimmer Dental Implant Surgical Kits Recalled for Manufacturing Defect

    Zimmer Dental Inc. is recalling 166 surgical kits because a manufacturing defect may prevent the driver from properly engaging dental implants.

    Product
    Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3104-2017·2017-09-13

    Stanmore JTS Distal Femoral Implant Recalled Due to Extension Failure

    Stanmore Implants Worldwide Ltd. is recalling 15 JTS Distal Femoral Extendible Implants because they may fail to extend as intended due to incorrect orientation or settings.

    Product
    JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-3100-2017·2017-09-06

    Smith & Nephew Recalls Polarstem Cardan Joints Due to Fracture Risk

    Smith & Nephew is recalling 402 Polarstem Cardan joints because the device may fracture or fail after multiple uses.

    Product
    smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2017·2017-04-26

    Laerdal Compact Suction Unit 4 Recalled for Electronic Component Damage

    Laerdal Medical Corporation is recalling 4,377 Compact Suction Unit 4 devices because an electronic component may be damaged, potentially affecting the On/Off functionality.

    Product
    Laerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 ml (3.3 lbs) canister version - CATALOG #(s): 88006101 - LCSU 4, 300 ml Complete unit (US), 88006103 - LCSU 4, 300 ml Complete unit (UK), 88006140 - LCSU 4, 300 ml Complete unit (EUR), 881151 - Replacement unit,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1481-2017·2017-03-22

    Philips BrightView X Nuclear Imaging System Recalled for Four Software and Hardware Issues

    Philips Medical Systems is recalling 1,218 BrightView X nuclear imaging systems worldwide due to four issues: motion controller failures, door interlock problems, detector contact risks, and software freezes.

    Product
    882478: BrightView X designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and noncircular)studi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0321-2017·2016-11-09

    Mindray TD60 Display Telemetry Transmitter Recalled for Bezel Cracking and Power Issues

    Mindray is recalling 1,278 TD60 Display Telemetry Transmitters because the bezel may crack or the device may fail to power on.

    Product
    TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2350-2016·2016-08-17

    Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments

    Intuitive Surgical is recalling da Vinci EndoWrist Stapler 30 instruments and reloads due to an increased trend of firing failures.

    Product
    CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or cr
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2145-2016·2016-07-20

    Ortho VITROS AFP Reagent Pack Recall Due to Calibration Failure

    Ortho Clinical Diagnostics is recalling specific lots of VITROS AFP Reagent Packs because they may fail to calibrate, potentially affecting test results.

    Product
    VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1994-2016·2016-06-22

    Anspach Universal Battery Charger II Recalled for Failure to Charge

    The Anspach Effort, Inc. is recalling 1,992 Universal Battery Charger II units because they enter safe mode and fail to charge batteries.

    Product
    Universal Battery Charger II (UBC II)
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-1874-2016·2016-06-08

    Philips Ingenuity Core 128 CT Systems Recalled for Drive Mapping Issue

    Philips Medical Systems is recalling 424 Ingenuity Core 128 CT systems because the system may not map the Varian drive after a user logout and login.

    Product
    Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1566-2016·2016-05-04

    Stryker PneumoSure Insufflators Recalled for Flow Rate Drop

    Stryker Endoscopy is recalling PneumoSure insufflators because the flow rate drops to zero when connected to a house gas source, suspending insufflation.

    Product
    PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator; High pressure units (HPU) (40L and 45L). Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 620-040-601, 620-040-602, 620-040-604, 105-210-684 The Pneumo Sure XL High F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1097-2016·2016-03-23

    Collagen Matrix Recalls NuOss XC Sinus Dental Grafts for Shelf Life Failure

    Collagen Matrix Inc is recalling 347 units of NuOss XC Sinus dental grafts distributed in Massachusetts because some products failed to expand properly during shelf life testing.

    Product
    NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) Manufacturer:- Collagen Matrix, Distributor:- ACE Surgical Supply Co, Inc, Intended use for dental surgery such as -augme
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1066-2016·2016-03-16

    Philips Allura Xper X-Ray Systems Recalled for Fluoroscopy Failure

    Philips is recalling 196 Allura Xper X-ray systems because they may display a 'Fluoro failed' error message when initiating fluoroscopy.

    Product
    Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and athere
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1026-2016·2016-03-09

    Ivoclar Vivadent Recalls Helioseal Clear Pit and Fissure Sealant

    Ivoclar Vivadent is recalling Helioseal Clear dental sealant because a production error may prevent the material from curing properly under specific lights.

    Product
    Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1018-2016·2016-03-02

    Sorin Group Recalls CDI H/S Cuvettes Due to Connection Error

    Sorin Group USA is recalling CDI H/S Cuvettes because they may fail to connect properly with the probe, causing the monitor to display an error and preventing blood parameter values from displaying.

    Product
    CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surger
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0213-2016·2015-11-11

    Ivoclar Recalls Helioseal F Dental Sealant Due to Production Defect

    Ivoclar A. G. is recalling specific lots of Helioseal F dental sealant because a production defect caused particles to be larger than defined, resulting in difficulties during extrusion.

    Product
    Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded fiss
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0210-2016·2015-11-11

    Steris Recalls AMSCO Steam Sterilizers Due to Foot Pedal Software Issue

    Steris Corporation is recalling 32 AMSCO 400 and AMSCO C Small Steam Sterilizers because a software defect prevents the foot pedal from operating the door.

    Product
    AMSCO 400 and AMSCO C Small Steam Sterilizers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0172-2016·2015-11-04

    Spacelabs CardioCall ECG Event Recorders Recalled for Battery Defect

    Spacelabs Healthcare is recalling CardioCall ECG Event Recorders because a battery defect causes continuous ringing and prevents normal operation.

    Product
    Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2448-2015·2015-09-02

    Alcon Recalls LX3 Microscope Floor Stands Due to Cabling Issues

    Alcon is voluntarily recalling LX3 Microscope Floor Stands because cabling issues may cause loss of functionality or illumination failure.

    Product
    LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Microscope with Q-VUE 3-D Assistant Visualization and provides a portable sus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2475-2015·2015-09-02

    Synthes Sternal ZIPFIX Application Instrument Recalled Due to Detaching End Cap

    Synthes (USA) Products LLC is recalling 451 Sternal ZIPFIX Application Instruments because the end cap may loosen and detach, rendering the instrument non-functional.

    Product
    Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2015·2014-10-29

    DeRoyal and Novaplus Suction Canisters Recalled for Insufficient Seal

    DeRoyal Industries is recalling 13,900 non-sterile suction canisters and lids because they may have an insufficient seal under low or intermittent suction conditions.

    Product
    Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only general hospital
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2268-2014·2014-08-27

    Ansar ANX-3.0 Autonomic Monitor Blood Pressure Circuit Recall

    Ansar Group is recalling 351 ANX-3.0 Autonomic Monitor systems because the blood pressure circuit may fail to inflate the cuff or activate, resulting in no blood pressure measurement.

    Product
    Blood pressure (BP) circuit of the ANSAR ANX-3.0 Autonomic Monitor system. The ANX 3.0 system is comprised of these components. 1. Patient Physiological Monitor, 2. Laptop Computer, 3. Stand w/wheels, 4. Patient cables, 5. Software components (Respiratory and Cardiac Spectral
    Category
    Medical Device
    Distribution
    Distributed nationwide