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.

176–200 of 299

  • ModerateFDA (Devices)·Z-0616-2016·2016-01-13

    Siemens Acute Care CCRP CalPak Recall for Barcode Scanning Issues

    Siemens is recalling 65 units of Acute Care CCRP CalPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus CS analyzer Catalog Number: CCCRP-C SMN:10445067
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0615-2016·2016-01-13

    Siemens Acute Care BHCG TestPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics is recalling 590 units of Acute Care BHCG TestPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0617-2016·2016-01-13

    Siemens Acute Care BHCG CalPak Recalled Due to Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc. is recalling 196 units of the Acute Care BHCG CalPak because the cartridge barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus¿ CS Acute Care rM ~ h CG method Catalog Number: CBHCG-C SMN:10445061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0619-2016·2016-01-13

    Siemens Acute Care CKMB DilPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc. is recalling 146 units of the Acute Care CKMB DilPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction with the Acute Care CKMB TestPak Catalog Number: CCKMB-D SMN: 10445070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0614-2016·2016-01-13

    Siemens Acute Care CCRP TestPak Recalled for Barcode Scanning Issues

    Siemens Healthcare Diagnostics Inc is recalling 78 units of the Acute Care CCRP TestPak because barcode labels may not scan on Stratus CS systems.

    Product
    Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of the CCRP method on the Stratus¿ CS analyzer Catalog Number: CCCRP SMN:10445066
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0469-2016·2015-12-30

    Instratek Recalls Angled Hook Blades for Endoscopic Tarsal Tunnel Decompression

    Instratek is recalling 39 sterile angled hook blades that do not fit into the handle of the Endoscopic Tarsal Tunnel Decompression system.

    Product
    Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
    Category
    Medical Device
    Distribution
    4 states
  • 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…
    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…
    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…
    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…
    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…
    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…
    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…
    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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide