Centeze Centesis Catheter — Class II medical device recall Z-0568-2021
Terminated recall by Galt Medical Corporation, reported 2020-12-23, distributed in FL, GA, MA, NC, NJ, OH, PA, PR…. Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse
| Recall number | Z-0568-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Galt Medical Corporation, Garland, TX, United States |
| Recall initiated | 2020-11-16 |
| Classified | 2020-12-14 |
| Reported by FDA | 2020-12-23 |
| Terminated | 2022-11-07 |
| Distributed | FL, GA, MA, NC, NJ, OH, PA, PR, UT |
| Countries outside the US | AE, CA, GB, NL, TR |
| Lot numbers | 20080351, 20217235, 20217236, 20217237, 20234573, 20297230, 21008452 |
| Model numbers | DRC-002-06, DRC-006-16 |
Product
Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16
Reason for recall
Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.
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-0568-2021. 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.