🏥 Medical Devices 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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95,018 total recalls in our database
🏥 Medical Devices 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: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 Software Version: N/A Component: N/A
Alcon Research
🏥 Medical Devices 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.
🏥 Medical Devices Class I - Dangerous
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
🏥 Medical Devices Class I - Dangerous
A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
🏥 Medical Devices 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+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106 Software Version: N/A Component: N/A
Alcon Research
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices 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.
🏥 Medical Devices 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.
🏥 Medical Devices 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.
ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011
Inari Medical - Oak Canyon
🏥 Medical Devices Class I - Dangerous
Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter bag 2) Catheter pulled through internal jugular vein access site or not pulled away from heart; may lead to device entrapment, pulmonary embolism, venous cutdown, abdominal surgery.
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.
🏥 Medical Devices Class I - Dangerous
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
🏥 Medical Devices 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
🏥 Medical Devices 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
🏥 Medical Devices Class I - Dangerous
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA) Catalog Number: 245128
Becton Dickinson &
🏥 Medical Devices Class I - Dangerous
May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility testing of Mycobacterium tuberculosis isolates.
🏥 Medical Devices Class I - Dangerous
The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.
🏥 Medical Devices Class I - Dangerous
IFU update to address device's battery handling information.