Medtronic Grafton DBM and Grafton Plus DBM Bone Grafts
Grafton DBM and Grafton Plus DBM may cause infection if implanted.
Medical device recalls
Medical device recalls from FDA, newest first.
1 recall
1 recall
AVID Medical Custom Surgical Procedure Kits
Davinci Trucustom Bundle may be contaminated with a lubricant used during manufacturing.
15 products
2 recalls
American Contract Systems BD Urinary Catheter Trays
Medical convenience kits with BD CliniClean Pericare Wipes may contain contaminated wipes causing skin irritation or infection risk.
3 products
American Nitrile Blue Nitrile Patient Examination Gloves
Blue Nitrile Patient examination gloves may have tears, missing fingers, and debris, which can expose people to infectious pathogens or chemical agents.
3 products
1 recall
Medline Convenience Kits
The kits contain neurological sponges with potential for unexpected variability of endotoxin levels.
5 products
2 recalls
AVID Medical Halyard IV Start Kits
Halyard IV Start Kit NON-Sterile may be contaminated with Aspergillus penicillioides.
Baxter Volara System
Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate.
1 recall
Cardinal Health 200 Presource Convenience Kits
Presource Convenience Kits contain applicators with open or incomplete seals, which could cause infection.
2 products
1 recall
Medline Convenience Kits for Anesthesia, Minor Procedures, Myringotomy and Cataract Surgery
Convenience kits may have open seals in sterile pouch packaging, which can compromise sterility and lead to contamination or patient infection.
4 products
2 recalls
AVID Medical Halyard IV Start Kits
Halyard IV Start Kit contains applicators contaminated with Aspergillus penicillioides.
Medline Convenience Kits
Medline Convenience Kits contain sterile applicators that may have fungal contamination, potentially causing serious infections.
7 products
1 recall
MedicaLyte and Citric Complete Concentrates
Hemodialysis concentrates contain high endotoxin levels.
4 products
2 recalls
Getinge PVC Thoracic Catheter
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
3 products
Bard Foley Catheter Trays and Intermittent Catheter Trays
Products that contain the Pericare Wipes may be contaminated on the surface.
6 products
1 recall
Cardinal Health 200 Presource Packs Containing CliniClean Pericare Wipes Within BD Urinary Catheter Trays
The wipes in these catheter trays may be contaminated with a lubricant, causing skin irritation.
12 products
2 recalls
Medline Convenience Kits with BD ChloraPrep Applicators
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators may have an open or incomplete seal, leading to infection.
13 products
Medline Convenience Kits
Medline Convenience Kits contain applicators with a potential breach of sterility in the packaging.
16 products1 recall
Halyard Medical Convenience Kits
Halyard medical convenience kits may contain neurological sponges with unexpected variability of endotoxin levels.
3 products
1 recall
Medline Convenience Kits
Medline convenience kits contain a potentially contaminated component.
11 products
1 recall
Medline Medical Convenience Kits
Medline medical convenience kits contain neurosponges with potential out-of-specification endotoxin levels.
4 products
1 recall
American Contract Systems Medical Procedure Kits and Trays
Medical procedure kits and trays may have unexpected variability of endotoxin levels on included sponges.
2 products1 recall
Cardinal Health Presource Kits
Procedure kits contain neurological sponges with unexpected variability in endotoxin levels.
8 products
1 recall
Spectra Medical Devices Sodium Chloride Injection
Sodium Chloride Injection, 0.9%, USP 10mL Ampule may have compromised sterility, exposing patients to microorganisms, endotoxins, or foreign matter.
1 recall
Medline Micro-Kill Bleach Germicidal Bleach Wipes
Medline Micro-Kill Bleach Germicidal Bleach Wipes may have reduced bleach concentration before the end of their shelf life.
4 products
1 recall
AMS Aligned Medical Solutions Surgical Procedure Packs
Medical convenience kits contain neurological sponges with potentially variable endotoxin levels.
4 products
1 recall
Medline Medical Convenience Kits
Medline medical convenience kits may be contaminated with low levels of Bacillus species.
4 products
1 recall
Medtronic Ventriculostomy Kit
Ventriculostomy kits may have endotoxin levels above the acceptable limit, which can cause an acute inflammatory process.
2 recalls
Aligned Medical Solutions Surgical Convenience Kits
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
4 products
Pilling Wecksorb Neurosponges and Neurosponge Strips
Pilling Wecksorb Neurosponges and Neurosponge Strips may have out-of-specification levels of endotoxins.
1 recall
AMD Medicom Ritmed Neurological Sponges
Ritmed Neurological Sponges may not consistently meet endotoxin specification for devices that contact cerebrospinal fluid.
2 products
1 recall
Codman CerebroFlo EVD Catheter with Endexo Technology
The CerebroFlo EVD Catheter has an out-of-specification endotoxin result that did not meet acceptance criteria.
1 recall
BioFire Joint Infection (JI) Panel
The BioFire Joint Infection Panel may be contaminated, leading to false positives.
2 recalls
Medline and Centurion Medical Convenience Kits
Medical convenience kits containing Webcol Large Alcohol Prep Pads may not be sterile due to a contaminant.
7 productsMedline Neuro Sponges
Medline Neuro Sponges may have higher-than-expected endotoxin levels.
31 products
1 recall
Immuno-Mycologics Myco DDR Trident Neutralization Buffer B
Neutralization Buffer may contain contaminants.
1 recall
Cytal Wound and Burn Matrices
Cytal Wound Matrix and Cytal Burn Matrix have an increased rate of out-of-specification endotoxin results.
5 products
1 recall
Puracol and Puracol Plus Collagen Wound Dressings
Puracol and Puracol Plus Collagen Wound Dressings have elevated endotoxin levels that may cause strong inflammatory response.
1 recall
International Life Sciences Artelon FlexBand Dynamic Matrix and FlexBand Plus
Artelon FlexBand devices failed bacterial endotoxin testing.
3 products
1 recall
Medline Kits with Tego Connectors
Medline kits containing Tego Connectors may have silicone seal issues that can cause fluid leakage or air infusion.
6 products