The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0899-2015·Announced 2015-01-07

Smiths Medical Recalls Hypodermic Needles Due to Safety Sheath Failure

Smiths Medical ASD, Inc. is recalling 10,000 units of Needle Pro Edge Safety Hypodermic Needles because the needle may not be captured in the safety sheath.

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 medical device where a safety mechanism failure (needle not captured in sheath) poses a risk of harm (needlestick injury), but no injuries or illnesses have been reported in the source text.

Plain-English summary

Smiths Medical ASD, Inc. is recalling 10,000 units of the Needle Pro Edge Safety Device with Syringe, 20G x 1 5/8 inch, 5mL Luer lock syringe (Reorder Number: 452010). The recall affects Lot Number 2755713.

The recall was initiated because the needle is not captured in the needle safety sheath in specific lots. This defect may compromise the safety features of the device intended for injection or aspiration of fluids.

The affected products 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. Users should stop using the affected needles and contact Smiths Medical ASD, Inc. for further instructions.

The recalled product

Product
Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010 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
10,000

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 Number: 2755713

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 →

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