The Recall Desk
HighFDA (Devices)·Z-0189-2020·Announced 2019-10-30

Smiths Medical Recalls GRIPPER Needles Due to Potential Occlusion

Smiths Medical ASD Inc. is recalling GRIPPER Needles because some may be occluded or blocked, posing a risk to patients.

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 is classified as FDA Class II, and the hazard involves a functional defect in a medical device (occluded needle) that poses a risk of harm, although no injuries have been reported.

Plain-English summary

Smiths Medical ASD Inc. is recalling GRIPPER Needles sold individually. The recall involves 3,952,425 devices distributed nationwide to all 50 states, the District of Columbia, Puerto Rico, and internationally. The affected products include various sizes and types of GRIPPER, GRIPPER PLUS, and GRIPPER MICRO needles, identified by specific item numbers and lot numbers listed in the official recall notice.

The reason for the recall is the potential for certain needles to contain an occluded or blocked needle. This defect could prevent the needle from functioning as intended during medical procedures. The source text does not report any illnesses or injuries associated with this defect.

Healthcare facilities and consumers should stop using the affected GRIPPER Needles immediately. Users should check their inventory against the specific item numbers and lot numbers provided in the full recall details to identify affected units. Smiths Medical ASD Inc. is the firm responsible for the recall.

The recalled product

Product
GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL, GRIPPER, 20G X 1.25" (32MM), 12/BX; 4. NDL, GRIPPER, 19G X 1" (25MM), 12/BX; 5. ND
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Needles
Hazard
Affected units
3,952,425

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 (20)

  • 1. Item Number 21-2714-24
  • Lot Numbers: 3655327
  • 3666475
  • 3671671
  • 3674631
  • 3675844
  • 3715667
  • 3716111
  • 3725093
  • 3731211
  • 3749579
  • 3749580
  • 3749581
  • 3769909
  • 2. Item Number 21-2715-24
  • Lot Numbers: 3674630
  • 3675843
  • 3677350
  • 3716110
  • 3725091

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Smiths Medical ASD Inc.

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Same hazard · occlusion

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