The Recall Desk
HighFDA (Devices)·Z-2004-2019·Announced 2019-07-31

Terumo 18G Needles Recalled for Potential Loss of Package Integrity

Terumo Medical Corporation is recalling 810,000 18G needles due to a potential loss of package integrity that may compromise sterility.

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 risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Terumo Medical Corporation is recalling 810,000 units of Terumo Needle, 18G x 1", Product Code NN1825R. The recall affects Lot Numbers 180714C and 180723C.

The recall was initiated because there is a potential for a loss of package integrity that may compromise the sterility of the product. The products were distributed to the following US states: FL, IN, KS, KY, MA, MO, NH, NV, PA, SC, TN, and TX.

Healthcare providers and consumers should stop using the affected needles and contact Terumo Medical Corporation for further instructions.

The recalled product

Product
Terumo Needle, 18G x 1", Product Code NN1825R
Affected units
810,000

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 (2)

  • Lot Numbers 180714C
  • 180723C

Distribution

Distributed in 12 states:

Part of a larger recall action

This product is one of 9 recalled by Terumo Medical Corporation 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 9 products in this recall →