Cardinal Health Recalls Magellan Syringes Due to Safety Shield Defect
Cardinal Health is recalling Magellan 3 mL syringes with hypodermic safety needles because the safety shield may fail to lock, posing a needlestick risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (needlestick exposure to bloodborne pathogens) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Cardinal Health 200, LLC is recalling 6,800 units of Magellan 3 mL Syringes with Hypodermic Safety Needles, 25 G x 5/8". The affected product is identified by Lot Codes 028610 and 028611. These syringes were distributed worldwide, including in the United States, the United Arab Emirates, and Japan.
The recall was initiated because the safety shield may fail to lock into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur, creating the potential for exposure to bloodborne pathogens.
Healthcare providers and consumers should stop using the affected syringes immediately. Users should check their inventory for the specific lot numbers listed above. For more information, contact Cardinal Health 200, LLC or refer to the FDA recall notice Z-1252-2021.
The recalled product
- Product
- 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
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 6,800
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Code: 028610
- 028611
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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