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.
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 2/5 (Moderate).
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…
- Hazard
- 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.
Related recalls
Same manufacturer · Integra LifeSciences Corp. d.b.a. Integra Pain Management
See all →- ModerateIntegra Recalls Spinal Tray Kits Missing Needle Introducer
FDA (Devices) · 2016-09-28
- HighIntegra Cranial Access Kits Recalled Due to Potential Sterility Compromise
FDA (Devices) · 2016-09-14
- HighIntegra Recalls Spinal Trays Due to Lidocaine Component Issue
FDA (Devices) · 2016-09-07
- HighIntegra Bone Marrow Biopsy Trays Recalled Due to Lidocaine Particulate
FDA (Devices) · 2015-11-04
- ModerateIntegra Tuohy Needles Recalled for Incorrect Length Labeling
FDA (Devices) · 2015-05-06
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateIntegra Tuohy Needles Recalled for Incorrect Length Labeling
FDA (Devices) · 2015-05-06
- HighEpimed Recalls TUOHY Epidural Needles Due to Potential Sterility Seal Issues
FDA (Devices) · 2017-11-15
- ModerateArrow International Recalls Tuohy Needles With Incorrect Expiration Dates
FDA (Devices) · 2020-02-26
- ModerateIntegra Recalls TS Series Depth Gauges for Incorrect Markings
FDA (Devices) · 2016-06-22
- ModerateIntegra LifeSciences Recalls Tibial Total Ankle Prosthesis Trays Due to Labeling Error
FDA (Devices) · 2019-04-24
- ModerateIntegra Tibial Total Ankle Prosthesis Tray Recalled for Labeling Error
FDA (Devices) · 2019-04-24