The Recall Desk
ModerateFDA (Devices)·Z-2056-2015·Announced 2015-07-15

Integra Recalls Tuohy Needles Due to Incorrect Gauge and Length Labeling

Integra LifeSciences is voluntarily recalling 123 Tuohy needles because they were incorrectly labeled as 18 gauge, 3.5 inch instead of 20 gauge, 5 inch.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding gauge and length, which fits the rubric for moderate severity.

Plain-English summary

Integra LifeSciences Corp. d.b.a. Integra Pain Management is voluntarily recalling 123 units of the Integra Long Epidural Steroid Injection Needle (Tuohy Needle). The affected needles are 20 gauge and 5 inches long, but they were incorrectly packaged and labeled as 18 gauge and 3.5 inches.

The recall is due to this packaging and labeling error. The needles are sterile, single-use devices used in pain management procedures to administer steroid medication in the epidural space. The affected lots were distributed nationwide.

Healthcare providers and consumers should stop using the affected needles and contact the manufacturer for instructions on return or replacement. The specific lot codes associated with this recall are W1404274, W1407165, W1409136, W1410082, W1412056, W1501065, and W1501181.

The recalled product

Product
Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra¿ Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra¿ Long Epidural Steroid Injection Needle is packaged
Affected units
123

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 (7)

  • W1404274
  • W1407165
  • W1409136
  • W1410082
  • W1412056
  • W1501065
  • W1501181

Distribution

Distributed nationwide across the United States.

Same manufacturer · Integra LifeSciences Corp. d.b.a. Integra Pain Management

See all →