CLASS II Device recall · Reported 24 Jun 2015 · FDA Enforcement Report
T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous recalled
Vidacare is recalling T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 10 Needle Set Sterile EO, distributed nationwide in the US. The recall was initiated on 12 May 2015 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-1801-2015
- FDA event ID
- 71247
- Recalling firm
- Vidacare, Shavano Park, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 May 2015
- FDA classified
- 15 Jun 2015
- Reported
- 24 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Syringes & Needles
Timeline
| 12 May 2015 | Recall initiated by company | |
| 15 Jun 2015 | Classified by FDA | +34 days |
| 24 Jun 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential breach in sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation
Where it was distributed
US Distribution to the states of : NC, MD, MS, TX and MO., and Internationally to Canada and Denmark.
Questions about this recall
Is T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 10 Needle Set Sterile EO recalled?
Yes. Vidacare recalled T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 10 Needle Set Sterile EO on 12 May 2015. The recall is Class II and its status is Terminated. Recall number Z-1801-2015.
Why was it recalled?
Potential breach in sterility
Which lots are affected?
3103376, 3103377, 3103378, 3524557, 3547157, 3693167, 3843307, 3868998, 3986753, 3991994, 3991995, 3999583, 4011996, 4023525, 4040723, 4040724
Where was it sold?
US Distribution to the states of : NC, MD, MS, TX and MO., and Internationally to Canada and Denmark.
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 Vidacare
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ez-io & up) Needle Set recalled by Vidacare | Vidacare | 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 |