BD gravity sets — Class II medical device recall Z-0350-2024
Ongoing recall by Becton Dickinson & Company, reported 2023-11-29, distributed nationwide. Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
| Recall number | Z-0350-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2023-10-11 |
| Classified | 2023-11-17 |
| Reported by FDA | 2023-11-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BR, CA, DO, IN, KW, MX, NZ, PH, PL, SA, SG, TW |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07613203020855, 10885403240867 |
| Model numbers | 32-IN, 4030B-07T, 42081E |
| Expiration dates | 2026-07-31 |
Product
BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.
Reason for recall
Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
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-0350-2024. 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.