Palindrome Precision SI Chronic Hemodialysis Catheter Sterile Barrier Recall
Mozarc Medical US LLC is recalling Palindrome Precision SI Chronic Hemodialysis Catheters (Sport Pack) due to a potential breach of sterile barrier packaging. Approximately 95,938 units distributed nationwide and in Canada and Mexico are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a sterile barrier breach—a risk-of-harm hazard for infection in hemodialysis patients. No reported illnesses or injuries are stated in the source, so the score is at most 3 per the rubric.
Plain-English summary
Mozarc Medical US LLC is recalling Palindrome Precision SI Chronic Hemodialysis Catheters (Sport Pack), radiopaque urethane catheters used for chronic hemodialysis. The recall was initiated due to a potential breach of sterile barrier packaging.
Approximately 95,938 units have been distributed worldwide, including throughout the United States, Canada, and Mexico. The affected catheters are identified by Model Numbers 8888133508P, 8888123408P, 8888119368P, and 8888128458P, along with specific serial numbers and UDI codes documented in the recall notice.
A compromised sterile barrier could potentially allow microbial contamination of the device, which could lead to serious infections in patients who rely on these catheters for hemodialysis treatment. Consumers and healthcare providers who have received affected units should contact Mozarc Medical US LLC or refer to the FDA recall notice for instructions on product return or replacement.
The recalled product
- Product
- Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.
- Manufacturer
- Mozarc Medical US LLC
- Hazard
- sterile-barrier-breach
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model No.8888133508P
- 8888123408P
- 8888119368P
- 8888128458P
- UDI: 20884521157931
- 20884521157795
- 20884521157726
- 20884521157863
- Serial No. 2234800132
- 2302500141
- 2302500148
- 2305300142
- 2305300144
- 2305300177
- 2313800083
- 2324100168
- 2324100310
- 2324100311
- 2405800229
- 2426300218
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22