Agency classClass IIOur severity:High FDA (Devices)·Z-1250-2021·Announced 2021-03-24

Cardinal Health Recalls Magellan Hypodermic Safety Needles Due to Locking Failure

Cardinal Health is recalling Magellan Hypodermic Safety Needles because the safety shield may fail to lock, creating a risk of needlestick injuries and exposure to bloodborne pathogens.

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 (medical device) where injury has not yet been reported, and the hazard involves high-risk pathogens (bloodborne pathogens), which aligns with the High severity criteria.

Plain-English summary

Cardinal Health 200, LLC is recalling 243,250 units of Magellan Hypodermic Safety Needles, 25 G x 5/8" (0.508 mm x 1.6 cm), under FDA recall number Z-1250-2021. The product is a single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

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, resulting in the potential for exposure to bloodborne pathogens.

The affected units are identified by Lot Code 025221. The products were distributed nationwide in the United States and in the countries of AE and Japan. Users should stop using the affected needles and contact Cardinal Health for further instructions.

The recalled product

Product: Magellan 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: 8881850558
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Needles
Hazard: needlestick
bloodborne-pathogens
Affected units: 243,250

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 (1)

Lot Code: 025221

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.

See all 3 products in this recall →

Same manufacturer · Cardinal Health 200, LLC

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Same hazard · needlestick