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.

176–200 of 293

  • HighFDA (Devices)·Z-0419-2016·2015-12-23

    Teleflex Medical Recalls Hudson RCI Adult Universal Ventilator Circuits

    Teleflex Medical is recalling 2,600 Hudson RCI Adult Universal Ventilator Circuits because the inspiratory and expiratory tubes are transposed.

    Product
    Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-0024-2016·2015-10-14

    Synthes Periarticular Insertion Handles and Aiming Arms Recalled for Fit Issues

    Synthes (USA) Products LLC is recalling 172 units of Periarticular Insertion Handles and Aiming Arms because they cannot be secured to subsequent device versions as intended.

    Product
    Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2804-2015·2015-09-30

    Leica ASP6025 Tissue Processor Recalled for Incomplete Bottle Filling

    Leica Microsystems is recalling ASP6025 Tissue Processors because they may incorrectly detect empty bottles during filling, preventing the completion of a 5-liter fill.

    Product
    The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2490-2015·2015-09-09

    Trilliant Surgical Recalls Out-of-Specification Fibula Plates

    Trilliant Surgical Ltd. is recalling 28 units of VL Gridlock Fibula Plates because insufficient thread depth may limit locking screw functionality.

    Product
    7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive pr
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2456-2015·2015-09-02

    Trilliant Surgical Reamer Heads Recalled for Guide Pin Fit Issues

    Trilliant Surgical Ltd. is recalling 638 Concave and Convex Reamer Heads because the cannulation may be too small to allow the Guide Pin to pass through freely.

    Product
    Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and recons
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2452-2015·2015-09-02

    Trilliant Surgical Recalls 3.0/4.0 Cannulated Drill Bits Due to Sizing Issue

    Trilliant Surgical Ltd. is recalling 121 units of 3.0/4.0 Cannulated Drill Bits because the inner diameter is too small for the guide wire to pass through.

    Product
    3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wire
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2465-2015·2015-09-02

    Tornier Recalls Salto Talaris Tibial Guide Due to Assembly Defect

    Tornier is voluntarily recalling five units of the Salto Talaris Tibial Guide because they cannot be assembled to the Talar Pin Setting guide.

    Product
    Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2083-2015·2015-07-22

    Maquet Recalls FLOW-i Anesthesia System Modules Due to Suction Failure

    Maquet is recalling 104 FLOW-i Anesthesia System Auxiliary O2 and Suction Modules because the suction function may not activate or be controlled by the switch.

    Product
    The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2074-2015·2015-07-22

    Nobel Biocare Recalls Zirconia Abutment Retrieval Instruments Due to Dimensional Error

    Nobel Biocare is recalling 149 units of Zirconia Abutment Retrieval Instruments and Kits because a dimensional error prevents the instruments from removing metal adapters as intended.

    Product
    Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2091-2015·2015-07-22

    Synthes Recalls Helical Blade Inserter for TFNA Due to Sizing Defect

    Synthes (USA) Products LLC is recalling 32 units of the Helical Blade Inserter for TFNA because an oversized pin prevents the tool from passing through the guide sleeve.

    Product
    Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1674-2015·2015-06-03

    DePuy Spine Recalls EXPEDIUM Offset Conical Lock Nut Devices

    DePuy Spine, Inc. is recalling 183 EXPEDIUM Offset Conical Lock Nut 8mm devices because they do not mate as intended.

    Product
    EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1584-2015·2015-05-13

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Image Loss

    Siemens Medical Solutions USA is recalling 476 ACUSON SC2000 ultrasound systems because post-exercise images may be lost during Stress Echo procedures.

    Product
    ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, A
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1501-2015·2015-04-29

    SenTec Recalls V-Sign Sensor 2 Due to Premature PCO2 Unit Deterioration

    SenTec AG is voluntarily replacing V-Sign Sensor 2 units because a part of the PCO2 measuring unit deteriorates prematurely, disabling PCO2 monitoring. The recall affects 129 units in the US and 59 outside the US.

    Product
    Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. The SenTec Digital Monitoring System (SDMS) is used for continuous and non-invasive monitoring of transcutaneous carbon dioxide tension (tcPCO2), oxygen saturati
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1444-2015·2015-04-22

    Hardy Diagnostics Recalls HardyCHROM SS Agar Due to Color Development Issue

    Hardy Diagnostics is recalling HardyCHROM SS Agar (Lot 15037) due to a report of possible lack of color development in Shigella organisms.

    Product
    Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2 to 8 degrees C. on receipt in dark A selective chromogenic medium for the primary screening isolati
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1319-2015·2015-04-01

    In2Bones Recalls DUAFIT Interphalangeal Implants Due to Dimensional Non-Conformity

    In2Bones is recalling 15 DUAFIT interphalangeal implants because dimensional non-conformity prevents them from fitting into their dedicated holders.

    Product
    DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1315-2015·2015-04-01

    Leica CD15 Antibody Recalled for Decreasing Staining Intensity

    Leica Microsystems is recalling 309 units of CD15 antibody because staining intensity decreases over shelf life.

    Product
    Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any sta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1268-2015·2015-03-25

    Med-logics Recalls ML 7090 Calibrated LASIK Blades Due to Fit Issues

    Med-logics Inc is recalling 360 units of ML 7090 Calibrated LASIK Blades because they do not fit into the AMO Amadeus Metal Blade Holder.

    Product
    ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated LASIK Blade (CLB) is to be used as replacement blades for the AMO Amadeus Microkeratome, to perform lamellar keratectomy procedures.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1277-2015·2015-03-25

    US Infusion Recalls Medstream IV Sets Due to Leaking

    US Infusion is recalling 62,700 Medstream IV infusion sets because they may leak at the Y site. The sets were distributed in six states.

    Product
    Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1263-2015·2015-03-18

    Ortho-Clinical VITROS Hand-held Barcode Scanner Recall for Sample Skipping

    Ortho-Clinical Diagnostics is recalling VITROS Hand-held Barcode Scanners because they may skip sample cup positions when using the Batch Programming option.

    Product
    VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS 3600 Immunodiagnostics System, VITROS 4600 Chemistry System, VITROS 5600 Integrated System. This product is an accessory for use with VITRO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1115-2015·2015-02-18

    Zimmer Dental Recalls GemLock Long Hex Driver Due to Fit Issues

    Zimmer Dental Inc is recalling 627 GemLock Long Hex Drivers because they may not fit into the Fixture Mount Transfer or the implant's internal hex.

    Product
    GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical Kit, Complete, Catalog TSVKIT. Used as a manual delivery tool that engages t
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0952-2015·2015-01-21

    Medtronic Spinal Surgical Instrument Recall Due to Component Sizing Issue

    Medtronic is recalling 24 units of the POWEREASE Set Screw Breakoff Instrument because oversized retaining tabs may prevent proper mating with the set screw.

    Product
    POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0986-2015·2015-01-21

    Stryker Recalls SurgiCounter Charging Cradles Due to Charging Defects

    Stryker is recalling 3,625 SurgiCounter Charging Cradles because they may fail to charge the scanner or download data after surgical procedures.

    Product
    The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of the SurgiCount Safety-Sponge System. The SurgiCount Safety-Sponge System is indicated for use in counting and recording the number of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0941-2015·2015-01-14

    CSA Medical truFreeze System Recalled for Timer Sound Loss

    CSA Medical is recalling 46 truFreeze cryogenic surgical devices because the timer may lose its audible sound, potentially affecting surgical procedures.

    Product
    CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by serial number. *** The truFreeze is intended for cryogenic destruction of t
    Category
    Medical Device
    Distribution
    25 states
  • ModerateFDA (Devices)·Z-0877-2015·2015-01-07

    Perouse Medical Recalls Synthes Inflation System Due to Pressure Limitations

    Perouse Medical is recalling 2,184 units of the Synthes Inflation System because the device may fail to raise pressure above 10 atm, potentially delaying procedures.

    Product
    Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to def
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0851-2015·2014-12-31

    Zimmer NexGen Knee Implant Drill Guide Recalled for Fit Issues

    Zimmer Trabecular Metal Technology is recalling 8 units of NexGen Complete Knee Solution drill guides because two units did not fit the handle during cleaning.

    Product
    NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular Metal Technology, Inc 10 Pomeroy Road, Parsippany, NJ 07054 USA
    Category
    Medical Device
    Distribution
    0 states