Hazard

Defective Component recalls

100 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 100
Critical: 1
Severe: 5
Most recent: 2025-06-11

Of the 100 defective component recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (5%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all defective component 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 100

ModerateFDA (Devices)·Z-1754-2014·2014-06-18
Stryker Round Fluted Bur Recall Due to Missing Notches
Stryker is recalling 609 sterile 3.0mm Round Fluted Burs because some units have missing or partial notches, which may affect their use with Elite Attachments.
Product
Stryker 3.0mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appli
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1771-2014·2014-06-18
Stryker Lindemann Drill Short Recalled for Missing Notches
Stryker is recalling 12 Lindemann Drill Short units because some cutting accessories may have missing or partial notches.
Product
Lindemann Drill Short, 1.6mm Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications inclu
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1768-2014·2014-06-18
Stryker 5.0mm Barrel Bur Recall Due to Missing Notches
Stryker is recalling 15 units of 5.0mm Barrel Bur Sterile because some units may have missing or partial notches.
Product
Stryker 5.0mm Barrel Bur Sterile
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1750-2014·2014-06-18
Stryker Round Fluted Bur Recalled for Missing Notches
Stryker is recalling 72 sterile 1.0mm Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.
Product
Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications in
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1769-2014·2014-06-18
Stryker 5.0mm Acorn Bur Recalled for Missing Notches
Stryker is recalling 71 units of 5.0mm Acorn Bur sterile cutting accessories due to missing or partial notches.
Product
Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1777-2014·2014-06-18
Stryker Neuro Drill Recall Due to Missing Notches on Cutting Accessories
Stryker is recalling 497 sterile neuro drills because some cutting accessories may have missing or partial notches, which could affect their use with Elite attachments.
Product
Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1779-2014·2014-06-18
Stryker 5.0mm Barrel Bur Recall for Missing Notches
Stryker is recalling 5.0mm Barrel Bur devices because some units have missing or partial notches, which may affect their use with Elite Attachments.
Product
Stryker 5.0mm Barrel Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1755-2014·2014-06-18
Stryker 5.5mm Round Fluted Bur Recall Due to Missing Notches
Stryker is recalling 99 sterile 5.5mm Round Fluted Bur Soft Touch devices because some units may have missing or partial notches.
Product
Stryker 5.5mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical appli
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1192-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling G2001 Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip. The devices are sterile, single-use in-vitro diagnostic tools used for drawing arterial blood.
Product
G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, Needle-Pro¿ Device and 23G x 1 needle Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of art
Category
Medical Device
Distribution
40 states
ModerateFDA (Devices)·Z-1190-2014·2014-03-19
Smiths Medical Recalls Arterial Blood Sampling Line Draw Syringes
Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to a defect in the plunger tip.
Product
G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap, and 5 mL Luer lock syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-0931-2014·2014-02-12
CareFusion Recalls Trifurcated Extension Sets Due to Potential Component Leak
CareFusion 303, Inc. is recalling Trifurcated Extension Sets (models ME 1224 and MP 9230) because a defect in the trifurcated component could result in a leak.
Product
Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0424-2014·2013-12-04
B. Braun addEASE Binary Connector Recalled for Possible Solution Leakage
B. Braun Medical is recalling addEASE Binary Connectors because a misaligned needle may cause solution to leak from the PAB bag.
Product
20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0062-2014·2013-10-30
Integra Licox Brain Tissue Oxygen Monitoring Kit Recall for Defective Hex Wrench
Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because some contain a hex wrench that may fail to loosen the set screw on the drill bit.
Product
Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0061-2014·2013-10-30
Integra Licox Brain Tissue Oxygen Monitoring Kits Recalled for Defective Hex Wrench
Integra LifeSciences is recalling Licox Brain Tissue Oxygen Monitoring Kits because some lots contain a hex wrench that may not loosen the set screw on the drill bit.
Product
Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2263-2013·2013-10-02
Steris Reliance Endoscope Processing System Recalled for Air Pipe Defect
Steris is recalling 266 Reliance Endoscope Processing Systems because an air pipe defect prevents forced flow during the disinfection cycle.
Product
Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-criti
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2104-2013·2013-09-04
Medtronic Perfusion Tubing Packs Recalled Due to Defective Suction Wand
Medtronic is recalling specific Perfusion Tubing Packs because they contain Rigid Suction Wands recalled by Edwards Lifesciences.
Product
Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1561-2013·2013-06-26
Linde Gas Recalls MEDICYL-e Portable Oxygen Systems Due to Valve Defect
Linde Gas North America is recalling MEDICYL-e Portable Oxygen Systems because some units may have misapplied valve flow knobs.
Product
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when admi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0687-2013·2013-01-23
Perkinelmer Recalls NEOBASE MSMS Kits Due to Defective Microplate Wells
Perkinelmer is recalling NEOBASE Non-Derivatized MSMS Kits because the microplate wells used in the assays are defective. This may affect the accuracy of newborn metabolic disorder screening.
Product
NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0690-2013·2013-01-23
Perkinelmer Recalls Defective Truncated V-Bottomed Microplates
Perkinelmer is recalling specific lots of truncated V-bottomed microplates because the wells are defective. These products are used for preparing and examining human body specimens.
Product
Microplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465. DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0686-2013·2013-01-23
Perkinelmer Recalls Defective NEOGRAM Tandem Mass Spectrometry Kits
Perkinelmer is recalling 180 NEOGRAM Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kits because they contain defective microplate wells.
Product
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0688-2013·2013-01-23
Perkinelmer Recalls Neonatal Total Galactose Kits Due to Defective Microplate Wells
Perkinelmer is recalling Neonatal Total Galactose Kits because the microplate wells used in the assays are defective, which may affect the accuracy of newborn screening results.
Product
NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper a
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0689-2013·2013-01-23
Perkinelmer Recalls Defective DBS Microplates for Assay Use
Perkinelmer is recalling 56 kits of DBS Microplates, Truncated V-Bottomed, due to defective wells that may affect assay results.
Product
DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0522-2013·2012-12-19
Roche Recalls Cobas b 123 Fluid Pack Cuvettes Due to Thickness Defect
Roche Diagnostics is recalling specific lots of Cobas b 123 Fluid Pack COOX cuvettes because a production error caused a change in layer thickness, leading to a higher failure rate.
Product
Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COH
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2131-2012·2012-08-08
ICU Medical Flush Kits Recalled for Stopcock Molding Defect
ICU Medical is recalling Flush Kits with 3 Way Off Stopcocks due to a molding defect that may occlude side ports.
Product
Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2129-2012·2012-08-08
ICU Medical Recalls Cardiac Catheterization Waste Management Systems
ICU Medical is recalling Cardiac Catheterization Waste Management Systems due to a molding defect in a high pressure stopcock that could cause side ports to become occluded.
Product
Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
Category
Medical Device
Distribution
Distributed nationwide