FDA Device recall Z-0072-2025
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
- FDA Device
- Class II
- ongoing
- Published 2024-10-23
On 2024-10-23 the FDA classified a Class II recall of basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/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-0072-2025 |
| 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
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/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): IN8130/JPC/00884450621073/H2929530(4/29/2027). IN8152/C/00884450621301/H2925219(4/22/2027)…REF/UDI-DI/Lot(Expiration): IN8130/JPC/00884450621073/H2929530(4/29/2027). IN8152/C/00884450621301/H2925219(4/22/2027), H2929412(4/29/2027), H2938005(5/12/2027), H2938006(5/12/2027), H2943498(5/19/2027), H2943499(5/19/2027), H2972593(5/26/2027), H2972594(5/26/2027), H2978092(6/3/2027). IN8302/C/00884450621325/H2925221(4/22/2027). IN8352/C/00884450621349/H2934719(5/5/2027). IN8802/C/00884450621417/H2925222(4/22/2027), H2934720(5/12/2027), H2943517(5/19/2027), H2972598(5/26/2027). IN8130/C/00884450621059/H2925215(4/22/2027), H2929410(4/29/2027), H2934714(5/5/2027), H2937998(5/12/2027), H2938000(5/12/2027), H2943487(5/19/2027). IN8130/C/00884450621059/H2972590(5/26/2027), H2978089(6/3/2027), H2978090(6/3/2027), H2978091(6/3/2027), H2989571(6/17/2027). |
|---|
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-0072-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.