Class IOngoingZ-0939-2026
Alcon Research LLC recalls Brand Name: Alcon Laboratories
Ophthalmic procedure packs may have incomplete seals affecting sterility.
- General Surgery Tray
- Packaging
Alcon Research LLCTXDec 31, 2025
Packaging
An FDA-recorded root-cause determination. The FDA lists 15 recalls with this root cause since 2025, 1 of them Class I (most serious). Most recent report: Dec 31, 2025.
Class I: 1Class II: 14
Latest recalls
View all 15 in the recall browser →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.
- Flexible Snare
- Packaging
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.
- Flexible Snare
- Packaging
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.
- Cemented Or Uncemented Metal/Polymer Femoral Hemi- Hip Prosthesis
- Packaging
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.
- Implanted Hemodialysis Catheter
- 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.
- Implanted Hemodialysis Catheter
- 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.
- Implanted Hemodialysis Catheter
- 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.
- Implanted Hemodialysis Catheter
- 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.
- Implanted Hemodialysis Catheter
- 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…
- General Surgery Tray
- Packaging
MEDLINE INDUSTRIES, LP…ILFeb 26, 2025
Class IIOngoingZ-0984-2025
Medtronic Perfusion Systems recalls DLP Pediatric One-Piece Arterial Cannulae
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
- Cardiopulmonary Bypass Vascular Cannula And Tubing Catheter
- Packaging
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.
- Cardiopulmonary Bypass Vascular Cannula And Tubing Catheter
- Packaging
Medtronic Perfusion Sy…MNJan 29, 2025
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.