FDA Device recall Z-0070-2025
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-…
- FDA Device
- Class II
- ongoing
- Published 2024-10-23
On 2024-10-23 the FDA classified a Class II recall of Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-… 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-0070-2025 |
| 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
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G
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): K05-00052M/00884450138120/H2934735(5/5/2027), H2943603(5/19/2027). K05-00053H/008844500529…REF/UDI-DI/Lot(Expiration): K05-00052M/00884450138120/H2934735(5/5/2027), H2943603(5/19/2027). K05-00053H/00884450052921/H2918538(4/22/2027), H2934736(5/5/2027). K05-00109G/00884450464533/H2918443(4/15/2027), H2925236(4/22/2027), H2943604(5/19/2027). K05-00137K/00884450290316/H2925237(12/31/2026), H2934737(5/12/2027). K05-00296L/00884450467824/H2918499(4/29/2027), H2925271(4/29/2027). K05-00399D/00884450138298/H2929510(4/29/2027), H2934739(5/12/2027). K05-00404C/00884450138304/H2918500(4/29/2027). K05-00410G/00884450142295/H2918501(4/15/2027), H2934833(5/12/2027). K05-00438G/00884450142301/H2918502(4/15/2027), H2934834(5/5/2027), H2978145(6/3/2027). K05-00502F/00884450138427/H2918505(4/15/2027), H2934837(5/5/2027). K05-00564L/00884450257166/H2934839(5/5/2027). K05-00587D/00884450052952/H2918446(4/22/2027), H2934744(5/5/2027), H2938620(5/12/2027). K05-00612Q/00884450138519/H2925240(4/22/2027), H2934746(5/5/2027), H2943608(5/26/2027). K05-00704F/00884450138588/H2918508(4/15/ |
|---|
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-0070-2025%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.