Integra Disposable — Class II medical device recall Z-0533-2014
Terminated recall by Integra LifeSciences Corp. d.b.a. Integra Pain Management, reported 2013-12-25, distributed nationwide. Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administrat
| Recall number | Z-0533-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT, United States |
| Recall initiated | 2013-10-28 |
| Classified | 2013-12-17 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2014-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 359,250 |
| Model numbers | 10-2433, 13-2595, 13-2616, 13-2628, 3104195, 3403061, 3403150, 3403316, 3403579, 3403727, 3403776, 3403813, 3403989, 3404131, 3404269, 3404293, 3404417, 3404468, 3404578, 3503559, CUS025, CUS1121-01, CUS1164-02, CUS1202-04, CUS1298-03 and 21 more |
Product
Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.
Reason for recall
Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may stall or stick when travelling within the syringe.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0533-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.