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.

126–150 of 299

HighFDA (Devices)·Z-0530-2018·2018-02-14
Angiodynamics Recalls Accu2i Microwave Tissue Ablation Applicators
Angiodynamics is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering microwave energy.
Product
Accu2i pMTA Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) H787900601US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0404-2018·2018-01-31
Intuitive Surgical Recalls da Vinci Xi EndoWrist Stapler 45 Instruments
Intuitive Surgical is recalling 60 da Vinci Xi EndoWrist Stapler 45 instruments due to a manufacturing variation that may prevent the release wrench from unclamping the device.
Product
daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0278-2018·2017-12-27
Philips HeartStart MRx Defibrillators Recalled for EtCO2 Module Contamination
Philips is recalling 20 HeartStart MRx defibrillators because EtCO2 module contamination may prevent the device from displaying the CO2 waveform.
Product
Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0237-2018·2017-12-20
Beckman Coulter UniCel DxH600 Hematology Analyzer Recall for Sample Aspiration Issue
Beckman Coulter is recalling the UniCel DxH600 automated hematology analyzer because a shield may interfere with sample aspiration.
Product
UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0046-2018·2017-11-01
Beckman Coulter Recalls Power Processor 1K Stockyard Due to Software Error
Beckman Coulter is recalling 27 Power Processor 1K Stockyard units because a software error may cause sample tubes to be retrieved during rack loading.
Product
Power Processor 1K Stockyard. The Power Processor performs all pre-analytical sample tube preparation.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0039-2018·2017-10-25
Teleflex Pilling Knife Handles Recalled for Blade Fit Issues
Teleflex Medical is recalling Pilling Knife Handles because the slot depth is out of specification, which may prevent blades from fitting properly.
Product
Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0012-2018·2017-10-25
Toshiba Medical Kalare Fluoroscopic X-Ray System Recalled for Image Display Failure
Toshiba American Medical Systems Inc is recalling 96 Kalare Fluoroscopic X-Ray Systems because images may fail to display on the system monitor or save to the hard disk.
Product
Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3238-2017·2017-10-11
BOMImed Laryngoscope Handle Recalled for Intermittent Lighting
Bomimed is recalling specific lots of Disposable Fiber Optic Medium Laryngoscope Handles due to a potential for intermittent lighting during use.
Product
BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel pouch, 20 handles per box. The rigid laryngoscope handle is a device used along with a blade to examine and visualize a patient's airway and aid placement of a tracheal…
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-2725-2017·2017-07-19
AMS Diagnostics Recalls Medica ISE Module Calibrant A Due to Physical Defects
AMS Diagnostics is recalling 9 units of Medica ISE Module Calibrant A because the lot was not functioning properly and did not exhibit correct physical properties.
Product
Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2183-2017·2017-06-21
GE Healthcare LightSpeed VCT X-ray System Recalled for Scan Timing Defect
GE Healthcare is recalling 10,884 LightSpeed VCT X-ray systems because a defect may cause scans to start before the prescribed delay completes.
Product
GE Healthcare LightSpeed VCT X-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2188-2017·2017-06-21
GE Healthcare Recalls BrightSpeed X-ray Systems Due to Scan Timing Defect
GE Healthcare is recalling 10,884 BrightSpeed X-ray systems because a defect may cause scans to start before a prescribed delay completes.
Product
GE Healthcare BrightSpeed X-ray system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2091-2017·2017-05-24
Vortran VARPlus Automatic Resuscitator Recalled Due to Connector Assembly Error
Vortran is recalling 35 cases of VARPlus Automatic Resuscitators because a connector was assembled in the reverse direction, preventing it from screwing onto the oxygen tubing.
Product
VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2033-2017·2017-05-10
Terumo Destination Renal Guiding Sheath Recalled for Missing Coating
Terumo Medical Corporation is recalling Destination Renal Guiding Sheaths because the distal end may lack the labeled 5 cm of coating, potentially making device navigation difficult.
Product
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1831-2017·2017-04-26
Neodent CM Intraoral Scanbody Recalled for Incompatibility with CM Implants
Instradent USA is recalling 170 Neodent CM Intraoral Scanbodies because the body diameter is incompatible with CM Implants when positioned subcrestally.
Product
NEODENT CM Intraoral Scanbody, Article Number: 108.139
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1709-2017·2017-04-12
Beckman Coulter Recalls Access 2 Immunoassay Systems Due to Circuit Board Defect
Beckman Coulter is recalling Access 2 Immunoassay Systems because a defective circuit board can cause the device to stop running and cancel tests in process.
Product
Access 2 Immunoassay Systems, Part No. 81600N Product Usage: The Access 2 and UniCel DxI Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1690-2017·2017-04-05
Nonin 8500M Handheld Pulse Oximeters Recalled for Incorrect Memory Board
Nonin Medical is recalling 15 units of the 8500M Handheld Pulse Oximeter because some devices may contain an incorrect pulse oximetry board lacking the integrated memory feature.
Product
8500M Handheld Pulse Oximeter
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1681-2017·2017-04-05
Merge Eye Care Systems Software Recall Due to Image Acquisition Failure
Merge Healthcare is recalling Eye Care Systems software because incompatible versions prevent the downloading or acquisition of new images.
Product
Merge Eye Care Systems, consisting of Merge Eye Station, Merge Eye Care PACS, and Merge Eye Station Import Utility (ESIU).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1394-2017·2017-03-08
BD AffirM VPIII Microbial Identification Test Recalled for Invalid Results
Becton Dickinson is recalling specific lots of the BD AffirM VPIII Microbial Identification Test because blue speckles or fibers may cause invalid test results.
Product
BD AffirM VPIII Microbial Identification Test
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1100-2017·2017-02-01
PerkinElmer AutoDELFIA Plate Processor Recalled for Potential Loading Failures
PerkinElmer is recalling AutoDELFIA Plate Processors with Version 3.0 software due to potential plate loading failures that could affect clinical assay results.
Product
AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number: 1235-5110 Product Usage: The Wallac 1235 AutoDELFIA automatic immunoassay system is designed to automatically perform assays using the DELFIA technology. DELFIA technology is based on the proven…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0957-2017·2017-01-18
Straumann Dental Implant Drills Recalled for Tolerance Specification Failures
Straumann Manufacturing is recalling 165 dental implant drills because they cannot be inserted into handpieces due to tolerance specification failures.
Product
Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Number: 044.210 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0958-2017·2017-01-18
Straumann Twist Drill PRO Recalled for Tolerance Specification Defects
Straumann Manufacturing is recalling 120 units of Twist Drill PRO dental implant accessories because they cannot be inserted into handpieces due to tolerance specification failures.
Product
Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0949-2017·2017-01-11
Merit PreludeEASE Hydrophilic Sheath Introducer Dilator Recall
Merit Medical Systems is recalling 335 PreludeEASE Hydrophilic Sheath Introducer Dilators because the tips are undersized and cannot pass a 0.021-inch guide wire.
Product
PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0943-2017·2017-01-11
MicroPort Orthopedics Recalls Profemur R Rasp Handles Due to Machining Issues
MicroPort Orthopedics is recalling 20 units of Profemur R Rasp Handles because machining issues may prevent them from properly mating with broaches.
Product
PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants. Broach handles mate to the broach to allow for preparation of the femoral canal for the stem component to be implanted. This
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0717-2017·2016-12-14
Ivoclar Vivadent Recalls Virtual XD Dental Impression Material
Ivoclar Vivadent is recalling Virtual XD Refill Light Body Fast Set Wash Material because the dental impression material may fail to set up properly.
Product
Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0718-2017·2016-12-14
Ivoclar Vivadent Recalls Virtual XD Dental Impression Material Due to Setting Failures
Ivoclar Vivadent is recalling Virtual XD Refill Light Body dental impression material because it may fail to set properly as it ages.
Product
Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material
Category
Medical Device
Distribution
Distributed nationwide