CLASS II Device recall · Reported 15 Jul 2015 · FDA Enforcement Report
Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle)ch recalled
Integra LifeSciences Corp. d.b.a. Integra Pain Management is recalling Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle)ch, distributed nationwide in the US. The recall was initiated on 1 May 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2056-2015
- FDA event ID
- 71147
- Recalling firm
- Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 May 2015
- FDA classified
- 9 Jul 2015
- Reported
- 15 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Syringes & Needles
Timeline
| 1 May 2015 | Recall initiated by company | |
| 9 Jul 2015 | Classified by FDA | +69 days |
| 15 Jul 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Needles (20 Gauge, 5 inch) due to incorrect packaging (labeled as 18 Gauge, 3. 5 inch).
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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 in a labeled and sterilized sealed tyvek / plastic pouch. The sterilized pouches are subsequently packaged in a case of 10 that is labeled, sealed and distributed to customers. Pain management procedure trays contain Tuohy Epidural Injection Needles to administer steroid medication in the epidural space. The needles are also available as an individually packaged single use, sterile device, as was the case with the affected lot in question.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle)ch recalled?
Yes. Integra LifeSciences Corp. d.b.a. Integra Pain Management recalled Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle)ch on 1 May 2015. The recall is Class II and its status is Terminated. Recall number Z-2056-2015.
Why was it recalled?
Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Needles (20 Gauge, 5 inch) due to incorrect packaging (labeled as 18 Gauge, 3. 5 inch).
Which lots are affected?
W1404274, W1407165, W1409136, W1410082, W1412056, W1501065, W1501181
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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