FDA Device recall Z-0064-2025
Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
- FDA Device
- Class II
- ongoing
- Published 2024-10-23
On 2024-10-23 the FDA classified a Class II recall of Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C 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-0064-2025 |
| 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
Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
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): IN7152/C/00884450381168/H2918432(4/15/2027), H2925197(4/22/2027), H2929406(4/29/2027), H292…REF/UDI-DI/Lot(Expiration): IN7152/C/00884450381168/H2918432(4/15/2027), H2925197(4/22/2027), H2929406(4/29/2027), H2929407(4/29/2027, H2934708(5/5/2027), H2937991(6/3/2027), H2937992(5/19/2027), H2943482(5/19/2027), H2972588(6/3/2027), H2972589(5/26/2027).: . IN7352/C/00884450409879/H2934710(5/5/2027). IN7403/C/00884450409886/H2943483(4/30/2027). IN7802/C/00884450498743/H2918435(4/22/2027), H2929409(4/29/2027), H2934711(5/5/2027), H2937995(5/12/2027), H2943485(5/19/2027), H2978087(6/3/2027). IN7852/C/00884450498750/H2937355(9/30/2025). IN7130/C/00884450409855/H2918431(4/15/2027), H2925196(4/22/2027), H2934706(5/5/2027), H2937988(6/3/2027), H2943481(5/19/2027), H2972587(5/26/2027), H2978086(6/3/2027). |
|---|
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-0064-2025%22
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