Access-9 Large Bore Hemostasis Valves — Class II medical device recall Z-0903-2022
Ongoing recall by Merit Medical Systems, Inc., reported 2022-04-20, distributed in AK, AL, AR, AZ, CA, CO, DC, DE…. A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rot
| Recall number | Z-0903-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2022-03-01 |
| Classified | 2022-04-11 |
| Reported by FDA | 2022-04-20 |
| Distributed | AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AT, BE, CA, CH, CO, CZ, DE, ES, FR, GB, GR, HN, IE, IT, JP, KR, LU, NL, PL |
| Quantity | 36,445 |
| Lot numbers | 580775001/I2219771, H2278279, H2281404, H2283742, H2287440, H2295556, H2295661, H2298626, H2302394, H2302474, H2302507, H2305047, H2305048, H2309356, I2176725, I2215955, I2226790, I2259657, I2278741, I2279884, I2279894, I2279895, I2279915, I2289610, I2289611, I2289612, I2289613, IN8112/C/H2292357, K05-00053H/H2305217, K05-00109G/H2304656, K05-00137K/H2304653, K05-00410G/H2305216, K05-00438G/H2309130, K05-00502F/H2309122, K05-00587D/H2309211, K05-01052/H2304607, K05-01140D/H2304611, K05-01706C, K05-01706C/H2309133, K05-01880K/H2306962 and 22 more |
| Model numbers | 580775001, 580775001/I2219771, I2226790, I2278741, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-01052, K05-01140D, K05-01706C, K05-01880K, K05-02130, K05-02595, K08-YP085A, K08-YS017B, K08-YS055A, K09-12599A, K09-YS029A, K09-YS040F and 15 more |
Product
Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-02130, K05-02595, K09-12599A, K10-05487P, K12-00264, MAP111/F, MAP112/B, MAP112/F, K08-YP085A, K08-YS017B, K08-YS055A, K09-YS029A, K09-YS040F, K12-YP002A, K12-YP030A, K12-YP060A, K12-YP061A, K12-YP063C, K12-YP072, K12-YS018A, K12-YS019A, K12-YS026A, K05-01140D, K05-01706C***, K05-02595, MAP112, K05-00564L, K12-YP002A,
Reason for recall
A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get caught, resulting in difficulty advancing the guidewire through the device. This defect may result in a delay of procedure.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0903-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.