Class IOngoingZ-0939-2026
Alcon Research LLC recalls Brand Name: Alcon Laboratories
Ophthalmic procedure packs may have incomplete seals affecting sterility.
Alcon Research LLCTXDec 31, 2025
Recalls: Packaging
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 15 recalls
Class IIOngoingZ-0483-2026
Olympus Corporation Of The Americas recalls Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: S…
Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
Olympus Corporation of…PANov 19, 2025
Class IIOngoingZ-0482-2026
Olympus Corporation Of The Americas recalls Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use E…
Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
Olympus Corporation of…PANov 19, 2025
Class IIOngoingZ-0432-2026
Total Joint Orthopedics, Inc. recalls Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar…
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Total Joint Orthopedic…UTNov 12, 2025
Class IIOngoingZ-1889-2025
Mozarc Medical US LLC recalls MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
Potential breach of sterile barrier packaging.
Mozarc Medical US LLCMAJun 11, 2025
Class IIOngoingZ-1888-2025
Mozarc Medical US LLC recalls Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane ca…
Potential breach of sterile barrier packaging.
Mozarc Medical US LLCMAJun 11, 2025
Class IIOngoingZ-1887-2025
Mozarc Medical US LLC recalls Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane c…
Potential breach of sterile barrier packaging.
Mozarc Medical US LLCMAJun 11, 2025
Class IIOngoingZ-1886-2025
Mozarc Medical US LLC recalls Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane…
Potential breach of sterile barrier packaging.
Mozarc Medical US LLCMAJun 11, 2025
Class IIOngoingZ-1885-2025
Mozarc Medical US LLC recalls Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane cath…
Potential breach of sterile barrier packaging.
Mozarc Medical US LLCMAJun 11, 2025
Class IIOngoingZ-1173-2025
MEDLINE INDUSTRIES, LP - Northfield recalls Medline RR-LIVER TRNS ACCESSORY PEDS
Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testi…
MEDLINE INDUSTRIES, LP…ILFeb 26, 2025
Class IIOngoingZ-0986-2025
Medtronic Perfusion Systems recalls Select Series Angled Tip Arterial Cannula
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Medtronic Perfusion Sy…MNJan 29, 2025
Class IIOngoingZ-0985-2025
Medtronic Perfusion Systems recalls EOPA Arterial Cannula
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Medtronic Perfusion Sy…MNJan 29, 2025