Recall record at a glance
| Official record | Z-0010-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Hobbs Medical, Inc. |
| Report date | Oct 19, 2022 |
| Recall initiation date | Jul 29, 2022 |
| Quantity | 275 units |
| Location | Stafford Springs, CT, United States |
Official product description
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Why the product was recalled
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.)
Distribution information
Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.