Medtronic DLP Vessel Cannula Recalled for Incorrect Labeling
Medtronic is recalling 4,343 units of DLP Vessel Cannula (Model REF 30000) due to incorrect labeling on three manufactured lots distributed globally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a labeling error on an FDA Class II medical device with no reported illnesses or injuries. Per the severity rubric, minor labeling errors without reported harm are classified as Moderate (2).
Plain-English summary
Medtronic Perfusion Systems is recalling 4,343 units of its DLP Vessel Cannula, Model Number REF 30000, due to incorrect labeling affecting three manufactured lots.
The affected lot numbers are 2023020890, 202305C126, and 2023020889. These units were distributed to the United States and internationally to Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy, Malaysia, South Africa, and the United Kingdom.
Healthcare providers and facilities that received affected units should verify that they have received this notice and take appropriate action regarding their inventory.
The recalled product
- Product
- Medtronic DLP Vessel Cannula, Model Number REF 30000
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device — Vessel Cannula
- Hazard
- Affected units
- 4,343
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 (4)
- UDI/DI 20613994646211
- Lot Numbers: 2023020890
- 202305C126
- 2023020889
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Medtronic Perfusion Systems
See all →- HighArterial Cannula Recall: EOPA 3D 22FR May Develop Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recalled Due to Risk of Pinhole Leaks During Bypass
FDA (Devices) · 2026-08-05
- HighArterial Cannula Recalled Due to Pinhole Leaks During Cardiopulmonary Bypass
FDA (Devices) · 2026-08-05
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- ModerateMedtronic Pediatric Arterial Cannulae Recalled for Incorrect Labeling
FDA (Devices) · 2025-01-29
- HighMedtronic Venous Cannulae: Wrong Product in Incorrect Packaging
FDA (Devices) · 2024-09-18
- HighMedtronic Vessel Cannulae Recalled for Potential Unsealed Sterile Packaging
FDA (Devices) · 2024-05-22
- ModerateMedtronic Arterial Cannula Recall Due to Incorrect Labeling
FDA (Devices) · 2025-01-29
- HighMedline Heart CABG Cannulae Recalled Due to Incorrect Model Labeling
FDA (Devices) · 2024-10-23
- HighMedtronic Recalls EOPA Arterial Cannula Models for Labeling Errors
FDA (Devices) · 2025-01-29