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.

76–100 of 299

  • HighFDA (Devices)·Z-0342-2020·2019-11-13

    Western Grab n Go Opti VIPR System Recalled for Control Knob Defect

    Western / Scott Fetzer Company is recalling 25,840 Grab n Go Opti VIPR systems because the control knob may rotate beyond its functional range, limiting access to flow settings.

    Product
    Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0340-2020·2019-11-13

    Western / Scott Fetzer Recalls Grab n Go Opti VIPR Oxygen Systems

    Western / Scott Fetzer is recalling 143,164 Grab n Go Opti VIPR oxygen systems because the control knob may rotate beyond its functional range, limiting access to flow settings.

    Product
    Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is an integrated delivery system intended to provide supplemental oxygen, by Rx only, to patients. When administered by properly trained personnel for oxygen deficiency and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0242-2020·2019-11-06

    Alto Development Recalls Thorecon Plating System Kits Due to Molding Defect

    Alto Development Corp is recalling 209 Thorecon Plating System Kits because a molding defect renders the disposable tensioners inoperable.

    Product
    A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0261-2020·2019-11-06

    Implant Direct Scan Adapter Assembly Recalled for Incorrect Assembly

    Implant Direct is recalling 107 Scan Adapter Assemblies due to incorrect assembly that may prevent clinicians from capturing implant positions, causing patient delays.

    Product
    Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0189-2020·2019-10-30

    Smiths Medical Recalls GRIPPER Needles Due to Potential Occlusion

    Smiths Medical ASD Inc. is recalling GRIPPER Needles because some may be occluded or blocked, posing a risk to patients.

    Product
    GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL, GRIPPER, 20G X 1.25" (32MM), 12/BX; 4. NDL, GRIPPER, 19G X 1" (25MM), 12/BX; 5.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2765-2019·2019-10-09

    Roche Recalls Accu-Chek Aviva II Meters Due to Damaged Capacitor

    Roche Diabetes Care is recalling 26,600 Accu-Chek Aviva II meters because a damaged capacitor may cause short battery life or prevent the device from turning on.

    Product
    Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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…
    Category
    Medical Device
    Distribution
    0 states
  • 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…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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…
    Category
    Medical Device
    Distribution
    2 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…
    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…
    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