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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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A
Alcon Research
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.
1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 Software Version: N/A Component: N/A
Alcon Research
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.
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.
Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations.
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
BioFire Diagnostics
Class I - Dangerous
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
Vial Decanter, REF 2006S. 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) TURNOVER KIT, REF DYKC1289F
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
IFU update to address device's battery handling information.
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.
Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: 8065000093 Software Version: N/A Component: N/A
Alcon Research
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.
Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450 Software Version: N/A Component: N/A
Alcon Research
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.
1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
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
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF DYKM2169
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.