FDA Device recall Z-0069-2025
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
- FDA Device
- Class II
- ongoing
- Published 2024-10-23
On 2024-10-23 the FDA classified a Class II recall of MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B 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-0069-2025 |
| 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
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
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): IN2430/B/00884450298053/H2918428(4/22/2027). IN2530/B/00884450298060/H2918429(4/22/2027),…REF/UDI-DI/Lot(Expiration): IN2430/B/00884450298053/H2918428(4/22/2027). IN2530/B/00884450298060/H2918429(4/22/2027), H2925194(4/22/2027), H2929405(4/29/2027), H2934699(5/5/2027), H2937986(5/12/2027), H2943479(5/26/2027), H2978085(6/3/2027), H2982496(6/10/2027). IN2130/B/00884450298022/H2918427(4/22/2027), H2925193(4/22/2027), H2929404(4/29/2027), H2934698(5/5/2027), H2937984(5/12/2027), H2943477(6/3/2027), H2972585(5/26/2027), H2982494(6/10/2027). |
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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-0069-2025%22
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