CLASS II ONGOING Device recall · Reported 19 Oct 2022 · FDA Enforcement Report
Hobbs Biliary Pigtail Stent Kits (containing 3412) recalled
Hobbs Medical is recalling Hobbs Biliary Pigtail Stent Kits (containing 3412), distributed nationwide in the US. The recall was initiated on 29 Jul 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0038-2023
- FDA event ID
- 90769
- Recalling firm
- Hobbs Medical, Stafford Springs, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jul 2022
- FDA classified
- 7 Oct 2022
- Reported
- 19 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 29 Jul 2022 | Recall initiated by company | |
| 7 Oct 2022 | Classified by FDA | +70 days |
| 19 Oct 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.)
Product as listed by the FDA
Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
Questions about this recall
Is Hobbs Biliary Pigtail Stent Kits (containing 3412) recalled?
Yes. Hobbs Medical recalled Hobbs Biliary Pigtail Stent Kits (containing 3412) on 29 Jul 2022. The recall is Class II and its status is Ongoing. Recall number Z-0038-2023.
Why was it 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.)
Which lots are affected?
UDI-DI: M84960040 Lot Numbers: H02-19-022
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Austria, Belgium, Finland, Norway.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hobbs Medical
All 73| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Posi-Stop Injection Needle recalled by Hobbs Medical | Hobbs Medical | Other | Nationwide |
| Device | CLASS II | Posi-Stop Injection Needle recalled by Hobbs Medical | Hobbs Medical | Other | Nationwide |
| Device | CLASS II | Posi-Stop Injection Needle recalled by Hobbs Medical | Hobbs Medical | Other | Nationwide |
| Device | CLASS II | Posi-Stop Injection Needle recalled by Hobbs Medical | Hobbs Medical | Other | Nationwide |
| Device | CLASS II | Posi-Stop Injection Needle recalled by Hobbs Medical | Hobbs Medical | Other | Nationwide |
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