Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Microtek Medical
Class I - Dangerous
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
Ventana Medical Systems
Class I - Dangerous
Their is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive results.
Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
GM60A. Digital Diagnostic Mobile X-Ray System.
NeuroLogica
Class I - Dangerous
Potential for the anti-fall system of the device arm to fail.
Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
Medline medical procedure kits labeled as follows: a) C-SECTION CDS, REF CDS983998C
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Class I - Dangerous
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Microtek Medical
Class I - Dangerous
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Microtek Medical
Class I - Dangerous
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Medline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b) MINOR BREAST, REF DYNJ905002B; c) SUCTION MEDI VAC, REF DYKM2033
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Class I - Dangerous
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class I - Dangerous
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class I - Dangerous
Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients.
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Class I - Dangerous
Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results.