CLASS II ONGOING Device recall · Reported 27 Nov 2024 · FDA Enforcement Report
Posi-Stop Injection Needle recalled by Hobbs Medical
Hobbs Medical is recalling Posi-Stop Injection Needle, distributed nationwide in the US. The recall was initiated on 4 Oct 2024 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-0470-2025
- FDA event ID
- 95577
- Recalling firm
- Hobbs Medical, Stafford Springs, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Oct 2024
- FDA classified
- 15 Nov 2024
- Reported
- 27 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 4 Oct 2024 | Recall initiated by company | |
| 15 Nov 2024 | Classified by FDA | +42 days |
| 27 Nov 2024 | 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
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Product as listed by the FDA
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706
Where it was distributed
Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
Nationwide ConnecticutGeorgiaIndianaMichiganMinnesotaMississippiNew HampshireNew JerseyNew YorkOhioTennesseeVermontWashingtonWisconsinWest Virginia
Questions about this recall
Why was it recalled?
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Which lots are affected?
Catalog Number: 4706; UDI-DI: M84947060; Lot Number: SD09-23-089.
Where was it sold?
Worldwide - US Nationwide distribution in the states of CT, GA, IN, MI, MN, MS, NH, NJ, NY, OH, TN, VT, WA, WI, WV and the country of Canada.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 95577This product is part of a recall event; the main page for the event is Posi-Stop Injection Needle recalled by Hobbs Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Posi-Stop Injection Needle recalled by Hobbs Medical | Hobbs Medical | Other | Nationwide | |
| CLASS II | Posi-Stop Injection Needle recalled by Hobbs Medical | Hobbs Medical | Other | Nationwide | |
| CLASS II | Posi-Stop Injection Needle recalled by Hobbs Medical | Hobbs Medical | Other | Nationwide | |
| CLASS II | Posi-Stop Injection Needle recalled by Hobbs Medical | Hobbs Medical | Other | Nationwide | |
| CLASS II | Posi-Stop Injection Needle recalled by Hobbs Medical | Hobbs Medical | Other | Nationwide | |
| CLASS II | Posi-Stop Injection Needle recalled by Hobbs Medical | Hobbs Medical | Other | Nationwide | |
| CLASS II | Posi-Stop Injection Needle recalled by Hobbs Medical | Hobbs Medical | Other | Nationwide | |
| CLASS II | Posi-Stop Injection Needle recalled by Hobbs Medical | Hobbs Medical | Other | Nationwide |
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 |
Other Syringes & Needles recalls
All 1,060| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |