3M Tube Securement Device — Class II medical device recall Z-1475-2024
Ongoing recall by 3M Company - Health Care Business, reported 2024-04-10, distributed nationwide. Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top film layer may b
| Recall number | Z-1475-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | 3M Company - Health Care Business, Saint Paul, MN, United States |
| Recall initiated | 2024-02-20 |
| Classified | 2024-04-03 |
| Reported by FDA | 2024-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CN, DE, FI, GB, IE, NO, NZ, PL, SE |
| Quantity | 265,435 eaches |
| UPC / GTIN / UDI-DI | 30707387792399, 30707387792405 |
| Lot numbers | 33KND8, 33KNJD, 33KNWC, 33KP6M, 33KT9M, 33KTDY, 33KTFP, 33KTLA, 33KTWT, 33KWHE, 33KWM3, 33TNDC, 33TNH3, 33TNMH, 33TNNN |
| Model numbers | 1500U, 1501U |
| Expiration dates | 2024-05-31, 2024-06-01, 2024-06-02, 2024-06-03, 2024-06-10, 2024-06-11, 2024-06-12, 2024-06-13, 2024-06-14, 2024-06-15, 2025-11-07, 2025-11-08, 2025-11-09 |
Product
3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 IN/PO x 3.5 IN/PO, REF 1501U, Sterile. Product is packaged 1 device per pouch, 25 pouches per primary carton, and 4 primary cartons per shipper box.
Reason for recall
Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top film layer may be partially or completely missing and some devices may exhibit the appearance of an incorrect shape due to excess material not being removed from the product liner.
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-1475-2024. 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.