Freeman Pancreatic Flexi-Stent Kits: Single Pigtail — Class II medical device recall Z-0050-2023
Ongoing recall by Hobbs Medical, Inc., reported 2022-10-19, distributed nationwide. Device label display an incorrect expiration date, extends the shelf life of the product. Affected product dis
| Recall number | Z-0050-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hobbs Medical, Inc., Stafford Springs, CT, United States |
| Recall initiated | 2022-07-29 |
| Classified | 2022-10-07 |
| Reported by FDA | 2022-10-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, FI, NO |
| Quantity | 3 units |
| Reason classes | labeling |
| Lot numbers | H05-20-155, H06-20-022 |
| Model numbers | 6503 |
Product
Freeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Catalog Number: 6503
Reason for recall
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
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-0050-2023. 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.