Swan-Ganz Catheter — Class II medical device recall Z-2202-2026
Ongoing recall by Becton, Dickinson and Company, reported 2026-05-27, distributed nationwide. Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal inject
| Recall number | Z-2202-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton, Dickinson and Company, Irvine, CA, United States |
| Recall initiated | 2026-04-08 |
| Classified | 2026-05-15 |
| Reported by FDA | 2026-05-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BH, BR, CA, CH, CL, CO, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IL, IR, IS, IT, JP, KW, LB, LU, MA, MT, NL, NO, NZ, OM, PL, PT, QA, RO, SA, SE, SI, SK, TN, TR, ZA |
| Quantity | 589,223 |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 00690103000245, 00690103000405, 00690103000412, 00690103000467, 00690103000504, 00690103000566, 00690103005134, 00690103018295, 00690103146554, 00690103146998, 00690103151756, 00690103153132, 00690103197303, 00690103217094, 00690103218282, 00690103218602 |
| Lot numbers | 096F6, 096F6P/00690103000245, 131F7/00690103000405, 141F7/00690103000504, 151F7/00690103000566, 831F75P/831F75-00690103003031, 834F75/00690103151756, C146F7/00690103153132, TS105F5/00690103018295 |
| Model numbers | 096F6/096F6P, 131F7/131F7P, 131F7J, 132F5, 141F7, 151F7, 774F75, 777F8, 782F75M, 831F75/831F75P, 834F75, AIQSGF8, C144F7, C146F7, TS105F5 |
Product
Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;
Reason for recall
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
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-2202-2026. 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.