Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with… — Class II medical device recall Z-0951-2026
Ongoing recall by Rocket Medical Plc, reported 2025-12-24, distributed in CO, CT, IL, MA, ME, NH, NJ, NM…. IFU and device kit labeling contains misleading statements leading to improper securing of the device resultin
| Recall number | Z-0951-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Rocket Medical Plc, Tyne & Wear, United Kingdom |
| Recall initiated | 2025-11-07 |
| Classified | 2025-12-18 |
| Reported by FDA | 2025-12-24 |
| Distributed | CO, CT, IL, MA, ME, NH, NJ, NM, OH, RI, SC, TX |
| Countries outside the US | AE, AT, AU, CA, DE, DK, FI, FR, GB, GR, HK, IE, IL, IN, IT, KE, LK, MT, NL, NO, NZ, PT, SA, SG, SI, ZA |
| Quantity | 240 units |
| Reason classes | labeling |
| Lot numbers | 497012, 497561, 497763, 498069, 499335, 499541, 499903, 500405, 500630, 500706, 500812, 501030, 501615, 502660, 502780, 502978, 503202, 503384, 503406, 503536, 503733, 503900, 504179, 504397, 504628, 504822 |
| Model numbers | R54544-12-SG |
Product
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Product Description: Chest tube manufactured from PVC, with fenestrations and a barium stripe to the indicated French gauge size. Supplied with a procedure pack to allow percutaneous insertion, supplied with connectors to allow attachment to chest drain bottle devices. Component: N/A
Reason for recall
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
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-0951-2026. 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.