CLASS II Device recall · Reported 24 Mar 2021 · FDA Enforcement Report
Magellan Syringe with Hypodermic Safety Needle x recalled
Cardinal Health 200 is recalling Magellan Syringe with Hypodermic Safety Needle x. A single lumen needle intended to, distributed nationwide in the US. The recall was initiated on 9 Feb 2021 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-1252-2021
- FDA event ID
- 87313
- Recalling firm
- Cardinal Health 200, Mansfield, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Feb 2021
- FDA classified
- 15 Mar 2021
- Reported
- 24 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 9 Feb 2021 | Recall initiated by company | |
| 15 Mar 2021 | Classified by FDA | +34 days |
| 24 Mar 2021 | 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
Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens
Product as listed by the FDA
Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 8881833558
Where it was distributed
Worldwide distribution - US Nationwide distribution and the countries of AE, Japan.
Questions about this recall
Why was it recalled?
Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens
Which lots are affected?
Lot Code: 028610, 028611
Where was it sold?
Worldwide distribution - US Nationwide distribution and the countries of AE, Japan.
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
2 other products · FDA event 87313This product is part of a recall event; the main page for the event is McKesson Prevent M Needle (Magellan Technology) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | McKesson Prevent M Needle (Magellan Technology) recalled | Cardinal Health 200 | Other | Nationwide | |
| CLASS II | Magellan Hypodermic Safety Needle x recalled by Cardinal Health 200 | Cardinal Health 200 | Other | Nationwide |
More recalls from Cardinal Health 200
All 283| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | 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 |