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.

76–100 of 293

  • ModerateFDA (Devices)·Z-2495-2019·2019-09-18

    Philips 5-Lead ECG Set Recalled Due to Connector Thickness Issue

    Philips is recalling 5-Lead ECG sets because the connector thickness may prevent or impede I 2-Lead ECG measurements.

    Product
    Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2357-2019·2019-08-28

    Cambridge Sensors Recalls Microdot Xtra Blood Glucose Test Strips

    Cambridge Sensors Limited is recalling Microdot Xtra blood glucose test strips in Illinois because faulty manufacturing equipment prevented the strips from fitting into the meter.

    Product
    Microdot Xtra blood glucose test strips
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1769-2019·2019-06-19

    Terumo Electronic Patient Gas System Recalled for Control Slider Failure

    Terumo is recalling 72 Electronic Patient Gas Systems used in cardio-pulmonary bypass because a fault disables control sliders, forcing use of local knobs.

    Product
    Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS), Electronic Gas Blender, Catalog #: 801188, UDI 00886799000588. Used in cardio-pulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1396-2019·2019-05-29

    Boston Scientific Recalls Auriga 30 Laser Systems Due to Power Degradation

    Boston Scientific is recalling specific Auriga 30 laser systems because a mechanical cooling issue may cause faster-than-normal power degradation and low power errors.

    Product
    AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform inc
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1391-2019·2019-05-29

    Boston Scientific Recalls Auriga XL 4007 Laser System for Cooling Defect

    Boston Scientific is recalling specific Auriga XL 4007 laser systems due to a mechanical cooling issue that may cause premature power degradation and low power errors.

    Product
    AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform inc
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1274-2019·2019-05-22

    Ethicon Endo-Surgery Recalls 33 mm Endoscopic Curved Intraluminal Staplers

    Ethicon Endo-Surgery Inc is recalling 434,614 Model ECS33A staplers worldwide because they may have an insufficient firing stroke to break the washer and form staples.

    Product
    Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1269-2019·2019-05-22

    Ethicon Curved Intraluminal Staplers Recalled for Insufficient Firing Stroke

    Ethicon Endo-Surgery Inc is recalling 434,614 Curved Intraluminal Staplers (Model CDH29A) because they may have an insufficient firing stroke to break the washer and completely form staples.

    Product
    Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1140-2019·2019-04-24

    Philips Medical Systems Recalls Foot Switches for Imaging Systems

    Philips Medical Systems is recalling 7,209 foot switches used with specific imaging systems because bent pedals may prevent live fluoroscopy images or exposures.

    Product
    Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1141-2019·2019-04-24

    Philips Medical Systems Recalls Foot Switches for Allura Xper Systems

    Philips Medical Systems is recalling 7,209 foot switches used with Allura Xper systems because pedals may bend, causing an inability to make live fluoroscopy images or exposures.

    Product
    Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005 Allura Xper FD10/10 722006 Allura Xper FD20 722008 Allura Xper FD20 Biplane 722010 Allura Xper FD10 722011 Allura Xper FD10/10 722012 All
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1063-2019·2019-04-03

    Keystone Dental Recalls Paltop 1.25 Hex Drivers Due to Sizing Issue

    Keystone Dental Inc is recalling Paltop 1.25 Hex Drivers because the hex driving feature may be slightly oversized, making it difficult to engage screws and abutments.

    Product
    Paltop 1.25 Hex Drivers, Long Part Number: 60-70101
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1062-2019·2019-04-03

    Keystone Dental Recalls Paltop Surgical Kits Due to Oversized Hex Driver

    Keystone Dental Inc. is recalling Paltop Fully Guided Surgical Kits because the included 1.25mm Hex Driver may be oversized, making it difficult to engage screws and abutments.

    Product
    Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1064-2019·2019-04-03

    Keystone Dental Recalls Paltop 1.25 Hex Drivers Due to Sizing Issue

    Keystone Dental Inc is recalling Paltop 1.25 Hex Drivers because the oversized feature makes it difficult to engage screws and abutments.

    Product
    Paltop 1.25 Hex Drivers, Short Part Number: 60-70102
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1061-2019·2019-04-03

    Keystone Dental Recalls Paltop Surgical Kits with Oversized Hex Drivers

    Keystone Dental Inc is recalling 13 Paltop Premium Surgical Kits because the 1.25mm Hex Drivers may be slightly oversized, making it difficult to engage screws and abutments.

    Product
    Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0935-2019·2019-03-06

    Becton Dickinson Recalls Phoenix AP AST Indicator Bags Due to Test Aborts

    Becton Dickinson is recalling Phoenix AP AST Indicator Bags because certain lots cause increased test aborts. The products were distributed to 40 US states and 33 foreign countries.

    Product
    Phoenix AP AST Indicator Bag, Catalog Number 246006
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-0757-2019·2019-01-30

    Fetzer De Lee Obstetric Forceps Recalled Due to Functional Defect

    Fetzer Medical is recalling 10 units of De Lee Obstetric Forceps because doctors reported being unable to pull the instruments apart.

    Product
    16600 / Fetzer Surgical De Lee Obstetric Forceps, 11" (30cm), Item No./Product Code 46-5034 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to faci
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0756-2019·2019-01-30

    Fetzer Medical Recalls Wrigley Obstetric Forceps Due to Functional Defect

    Fetzer Medical is recalling 10 units of Wrigley Obstetric Forceps because doctors reported being unable to pull the instruments apart.

    Product
    12002 / Boss Instruments Ltd. Wrigley Obstetric Forceps, 11" (28cm), Item No./Product Code 46-5004 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order t
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0758-2019·2019-01-30

    Fetzer Medical Recalls Simpson OB Forceps Due to Functional Defect

    Fetzer Medical is recalling 2 units of Simpson OB Forceps because doctors reported being unable to pull the instruments apart.

    Product
    12002 / Boss Instruments Simpson OB Forceps, short model, 13" (33cm), Item No./Product Code 46-5040 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0755-2019·2019-01-30

    Fetzer Medical Recalls Obstetrical Forceps Due to Functional Defect

    Fetzer Medical is recalling 174 units of Luikart Simpson OB Forceps because doctors reported being unable to pull the instruments apart.

    Product
    16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm), Item No./Product Code 46-5050 Fetzer Medical Obstetrical Forceps is a hand-held instruments intended to assist the birth of a foetus during difficult vaginal births through grasping the foetal head in order to f
    Category
    Medical Device
    Distribution
    2 states
  • 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 fl
    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-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-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-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