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.

276–299 of 299

LowFDA (Devices)·Z-1025-2013·2013-04-10
Viscot Medical Recalls Dual Tip Markers Due to Inconsistent Ink Flow
Viscot Medical LLC is recalling 458,589 sterile dual tip markers because the black permanent ink side has inconsistent ink flow.
Product
Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0922-2013·2013-03-20
Instratek Recalls Endotrig Trigger Release Blades Due to Cannula Advancement Issues
Instratek is recalling 235 Endotrig Trigger Release Sterile Micro Hook Blades because they could not be advanced into the cannula during procedures.
Product
Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0941-2013·2013-03-20
Synthes Large Combination Clamp Recalled Due to Oversized Hex Nuts
Synthes USA is recalling 136 Large Combination Clamps because oversized hex nuts prevent standard 11 mm sockets and wrenches from fitting.
Product
Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0738-2013·2013-02-06
bioMerieux Recalls BacT/ALERT SA Blood Culture Bottles with Uncured Sensors
bioMerieux, Inc. is recalling BacT/ALERT SA Blood Culture Bottles because some units may contain uncured sensors, potentially affecting the detection of microorganisms.
Product
BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
Category
Medical Device
Distribution
29 states
ModerateFDA (Devices)·Z-0739-2013·2013-02-06
Becton Dickinson Recalls BBL Fildes Enrichment Tubes for Growth Failure
Becton Dickinson is recalling BBL Fildes Enrichment tubes because they may fail to support the growth of Haemophilus species, potentially affecting laboratory test results.
Product
BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA*** Intended Use: Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms. Fildes Enrichment…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0483-2013·2012-12-19
Hospira Recalls Plum A+ Infusion Pumps Due to Volume Knob Defect
Hospira is recalling Plum A+ infusion pumps because the volume control knob may reverse the alarm volume direction.
Product
Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0505-2013·2012-12-19
ConMed Recalls WANG Transbronchial Aspiration Needles Due to Fit Issues
ConMed is recalling WANG Transbronchial Aspiration Needles because they may not fit through a 2.0 mm bronchoscope, causing minor inconvenience.
Product
WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use…
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-0503-2013·2012-12-19
ConMed Recalls WANG Transbronchial Aspiration Needles for Fit Issues
ConMed is recalling WANG Transbronchial Aspiration Needles because they may not fit through a 2.0 mm bronchoscope channel, causing minor inconvenience.
Product
WANG Transbronchial Aspiration Needles Cat. No. MW-322, WANG Cytology Needles, Central, Mediastinal and Hilar Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed…
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-0481-2013·2012-12-19
Hospira Recalls Plum A+ Infusion Pumps Due to Reversed Volume Knob
Hospira is recalling Plum A+ single channel infusion pumps because the volume control knob may function in reverse, causing alarm volume to increase when turned clockwise.
Product
Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0138-2013·2012-10-31
Nipro AquaLiner Hydrophilic Guidewire Recalled for Insufficient Lubricity
Nipro Medical Corporation is recalling AquaLiner Hydrophilic Guidewires because insufficient lubricity causes them to get stuck in the housing and become nonfunctional.
Product
AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0134-2013·2012-10-31
Nipro AquaLiner Hydrophilic Guidewire Recalled for Insufficient Lubricity
Nipro Medical Corporation is recalling AquaLiner Hydrophilic Guidewires because insufficient lubricity causes them to get stuck in the housing and become nonfunctional.
Product
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2376-2012·2012-09-19
GE Healthcare Recalls Innova 2121IQ and 3131IQ X-ray Systems
GE Healthcare is recalling Innova 2121IQ and 3131IQ systems due to a potential loss of imaging mode requiring a restart.
Product
GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and…
Category
Medical Device
Distribution
33 states
HighFDA (Devices)·Z-2234-2012·2012-08-29
Exactech Recalls Optetrak Proximal Tibial Spacers Due to Dimensional Incompatibility
Exactech, Inc. is recalling 70 Optetrak Proximal Tibial Spacers because they are dimensionally incompatible with the Logic Tibial Tray.
Product
OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508. The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2210-2012·2012-08-22
Maquet Pediatric Arterial Cannula Recall for Limited Flexibility
Maquet Inc. is recalling certain pediatric arterial cannulas because the hardened tip may be too long, limiting flexibility during extracorporeal circulation procedures.
Product
Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 [email protected] www.maquet.com Used to introduce blood and sterile solution to the circulation system during…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2137-2012·2012-08-15
Transenterix Recalls SPIDER Flexible Clip Applier Surgical Instruments
Transenterix is recalling SPIDER Flexible Clip Applier surgical instruments because some units may fail to close clips properly during minimally invasive procedures.
Product
SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER¿ Surgical Instruments are intended for use in minimally invasive surgical procedures for grasping, mobilizing, dissecting, retracting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2101-2012·2012-08-08
Intuitive Surgical Recalls Instrument Arm Drapes Due to Adaptor Engagement Issues
Intuitive Surgical is recalling specific lots of Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument during surgical procedures.
Product
INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2103-2012·2012-08-08
Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes
Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.
Product
KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2084-2012·2012-08-01
Stryker Recalls Tibial Punch Tower Assembly Due to Undersized Slot
Stryker Howmedica Osteonics is recalling 152 units of Tibial Punch Tower Assemblies because an undersized slot may prevent keel punches from being inserted.
Product
Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ 07401. During primary Scorpio TKA procedures, the Scorpio Tibial Punch Tower (8000-1089) is used in conjunction with Scorpio Tibial Keel Punches…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1964-2012·2012-07-18
Terumo Advanced Perfusion System 1 Gas Control Recall
Terumo is recalling 992 Advanced Perfusion System 1 units due to reported difficulty adjusting the gas flow control knob.
Product
Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1934-2012·2012-07-11
Aesculap S4 Cervical Revision Instruments Recalled for Tolerance Issues
Aesculap Implant Systems LLC is voluntarily removing S4 Cervical Revision Instruments because they may not thread into screws properly during surgery.
Product
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1812-2012·2012-06-27
Tripath PrepStain GYN 480 Test Kits Recalled for Leaking Pipettes
Tripath Imaging is recalling PrepStain GYN 480 Disposable Test Kits because the syringing pipettes may leak and fail to dispense the required sample volume.
Product
PrepStain GYN 480 Disposable Test Kit with PreCoat Slides (Catalog #490523
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1811-2012·2012-06-27
Tripath PrepStain Syringing Pipettes Recalled for Leaking Defect
Tripath Imaging is recalling PrepStain Syringing Pipettes 240 because they may leak and fail to dispense the minimum required sample volume.
Product
PrepStain Syringing Pipettes 240 (Catalog #490517)
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1851-2012·2012-06-27
Boston Scientific Pediatric Snare Recalled for Extension Difficulty
Boston Scientific is recalling 1,970 Profile Single-Use Pediatric Snares because the loop may be difficult to extend from the catheter.
Product
Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1815-2012·2012-06-27
Tripath PrepStain Syringing Pipettes Recalled for Leaking Defect
Tripath Imaging is recalling PrepStain Syringing Pipettes because they may leak and fail to dispense the minimum required volume of 7.5 mL.
Product
PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240)
Category
Medical Device
Distribution
0 states