Class II — Hobbs Medical, Inc.
| Recalling firm | Hobbs Medical Inc |
|---|---|
| Registered facility | HOBBS MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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.) |
| Product | Hobbs Medical Flex-Ez Guide Wire Disposable For endoscopy procedures Ref: 3412 |
| Quantity | 32 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway. |
| Initiated | 2022-07-29 |
| Classified | 2022-10-07 |
| Recall number | Z-0012-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hobbs Medical, Inc. (Z-0012-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90769/
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