Medtronic Disposable Pressure Display Sets recalled for unsealed sterile packaging
Medtronic Perfusion Systems recalls 1,624 Disposable Pressure Display Sets (Models 61000 and 62000) distributed worldwide due to potential for unsealed sterile packing. No illnesses or injuries have been reported.
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 3/5 (High).
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 recall scores High (3) because it involves a risk-of-harm medical device with potential for sterility compromise, but no illnesses or injuries have been reported. The FDA Class II designation indicates the defect requires correction; however, the theoretical nature of the hazard and absence of reported adverse events place it at Score 3 rather than higher.
Plain-English summary
Medtronic Perfusion Systems recalls 1,624 Disposable Pressure Display Sets (Models 61000 and 62000) distributed worldwide due to potential for unsealed sterile packing.
Unsealed sterile packing may compromise the sterility of the medical devices. No illnesses or injuries have been reported in connection with this recall.
Affected lot numbers are listed in the FDA recall notice. Healthcare providers and consumers with these products should contact Medtronic Perfusion Systems for guidance on device replacement or return.
The recalled product
- Product
- Medtronic Disposable Pressure Display Sets: a) DLP¿ 114.3 cm (45 in), Model Number 61000; b) DLP¿ 114.3 cm (45 in), Model Number 62000
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device
- Affected units
- 1,624
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 (17)
- a) Model Number 61000
- GTIN 00643169880955
- Lot Numbers: 2023030432
- 2023030433
- GTIN 20643169880959
- Lot Numbers: 2023030431
- 2023030432
- 2023030734
- 202305C226
- 202307C176
- 202307C177
- b) Model Number 62000
- GTIN 20613994846642
- Lot Numbers: 2023030223
- 2023030736
- 2023031580
- 202305C225
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 13 recalled by Medtronic Perfusion Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →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 · unsealed packaging
See all →- HighMedtronic Cardioplegia Adapters recalled for potential unsealed sterile packaging
FDA (Devices) · 2024-05-22
- HighMedtronic Vessel Cannulae Recalled for Potential Unsealed Sterile Packaging
FDA (Devices) · 2024-05-22
- HighMedtronic Left Heart Vent Catheters recalled for unsealed sterile packaging
FDA (Devices) · 2024-05-22
- HighMedtronic Venous Cannulae Recalled for Unsealed Sterile Packaging
FDA (Devices) · 2024-05-22
- HighMedtronic Aortic Root Cannulae and Cardioplegia Needles Recalled for Unsealed Sterile Packing
FDA (Devices) · 2024-05-22
Similar recalls
- ModerateMedtronic Recalls DLP Pressure Display Sets Due to Packaging Pinholes
FDA (Devices) · 2017-08-02
- HighMedtronic Recalls Disposable Sterile Surgical Devices Due to Sterility Concerns
FDA (Devices) · 2014-11-26
- HighMedtronic Recalls Disposable Surgical Devices Due to Sterility Control Issues
FDA (Devices) · 2014-11-26
- HighSterile Surgical Drape Recalled Due to Potential Packaging Breach
FDA (Devices) · 2025-03-26
- HighMedline Medical Procedure Drape Packs Recalled Due to Non-Sterile Packaging Risk
FDA (Devices) · 2024-10-30
- HighLivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach
FDA (Devices) · 2017-08-09