The Recall Desk
HighFDA (Devices)·Z-0898-2015·Announced 2015-01-07

Smiths Medical Recalls Hypodermic Needles Due to Safety Sheath Failure

Smiths Medical ASD, Inc. is recalling specific lots of Needle Pro Edge safety hypodermic needles because the needle is not captured in the safety sheath.

What this means for you

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 medical device with a safety mechanism failure that poses a risk of harm (needlestick injury), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Smiths Medical ASD, Inc. is recalling 47,200 units of the Needle Pro Edge Safety Device with Syringe (20G x1 10mL Luer lock syringe). The recall affects specific lots, identified by lot numbers 2756526 and 2771498, which were distributed nationwide in the states of AZ, CA, FL, GA, IL, IN, LA, MA, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OR, PA, RI, TN, TX, VA, WA, WI, and WV.

The recall is being conducted because the needle is not captured in the needle safety sheath in the affected lots. This failure of the safety mechanism could potentially expose users to the needle.

Consumers and healthcare facilities should check their inventory for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to the supplier or the manufacturer for further instructions.

The recalled product

Product
Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe.
Manufacturer
Smiths Medical ASD, Inc.
Category
Medical Device — Hypodermic Needles
Hazard
Affected units
47,200

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 Numbers: 2756526
  • 2771498

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Smiths Medical ASD, Inc. 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 →

Related recalls

Same manufacturer · Smiths Medical ASD, Inc.

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Same hazard · needlestick injury

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