Getinge PVC Thoracic Catheter
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
3 products
Medical device recalls
Medical device recalls from FDA, newest first.
1 recall
2 recalls
American Contract System Convenience Kits
American Contract System Convenience Kits did not meet applicable performance specifications.
4 products
Medline Medical Convenience Kits
Medline medical convenience kits contain neurosponges with potential out-of-specification endotoxin levels.
4 products
1 recall
Thermo Fisher Diagnostics Neisseria Meningitidis Gp C Tests
Neisseria meningitidis Gp C 2ml/VL is not performing to IFU criteria, not positive to ATCC13102 within 60 seconds.
1 recall
Aniara Diagnostica 5-PLASMA Bivalirudin Kits, Calibrators and Controls
The 5-Plasma Bivalirudin AMR Verification Kit has stability issues that degrade measurable bivalirudin.
3 products
2 recalls
Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls have out-of-specification sodium azide concentration, causing low health risk.
Syva Emit Disopyramide Assay Enzyme Immunoassay
The Syva Emit Disopyramide Assay has an out-of-specification sodium azide concentration, which can cause mild skin or eye irritation.
1 recall
Terex Utilities Power Over Fiber Base Module
The Power Over Fiber Base Module is not certified and is improperly labeled.
1 recall
Vasoview Hemopro 2 Endoscopic Vessel Harvesting System
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System was exposed to an out-of-specification sterilization dose.
1 recall
ConvaTec Aquacel Ag Surgical SP
Surgical dressing manufactured out of specification (greater thickness).
2 recalls
Zeiss Intrabeam Spherical Applicator 1.5 cm
The Zeiss Intrabeam Spherical Applicator 1.5 cm failed to meet manufacturing specifications.
Pilling Wecksorb Neurosponges and Neurosponge Strips
Pilling Wecksorb Neurosponges and Neurosponge Strips may have out-of-specification levels of endotoxins.
1 recall
Medline Urethral Catheters and Procedure Kits
Medline urethral catheters and kits may have surface irregularities or connector issues.
30 products
1 recall
Halyard Purezero Ultraviolet Nitrile Exam Gloves
Nitrile exam gloves failed to meet chemical permeation performance specifications.
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
Medline Neuro Sponges
Medline Neuro Sponges may have higher-than-expected endotoxin levels.
31 products
1 recall
Oxoid Agglutinating Sera, Salmonella 9-0
Oxoid Agglutinating Sera, Salmonella 9-0 is not performing to IFU criteria, showing cross reactions.
2 recalls
Cytal Wound and Burn Matrices
Cytal Wound Matrix and Cytal Burn Matrix have an increased rate of out-of-specification endotoxin results.
5 products
React Health PHOENIX 5L Oxygen Concentrator
The React Health PHOENIX 5L Oxygen Concentrator was distributed without meeting internal quality specifications.
1 recall
OrthAlign Lantern Knee System Drill Plates
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm).
2 products