FDA Device recall Z-0067-2025
IntelliSystem Inflation Device, REF: IN1525/D
- FDA Device
- Class II
- ongoing
- Published 2024-10-23
On 2024-10-23 the FDA classified a Class II recall of IntelliSystem Inflation Device, REF: IN1525/D by Merit Medical Systems, citing inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0067-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-19 |
| Published | 2024-10-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
IntelliSystem Inflation Device, REF: IN1525/D
Reason
Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.
Identifiers
| code_info | REF/UDI-DI/Lot(Expiration): IN1525/D/00884450298015/ H2918426(4/22/2027), H2934697(1/31/2027) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0067-2025%22
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