Needle, Conduction, Anesthetic (w/wo Introducer)
Anesthesiology · 21 CFR 868.5150
Recent MDR events
1,308 adverse event reports on file
- PENCAN SPINAL NEEDLEJul 30, 2026OtherMW6000123
- NEEDLE SPINAL BNS 22GA 3-1/2IN QUINCKEJul 29, 2026MalfunctionBd Caribe Ltd.2618282-2026-00151
- Portex Pain Management KitJul 27, 2026MalfunctionIcu Medical, Inc.3012307300-2026-07675
- NEEDLE SPINAL S/SU 27GA 3-1/2IN QUINCKEJul 27, 2026MalfunctionBd Caribe Ltd.2618282-2026-00118
- SPROTTE®Jul 21, 2026InjuryPajunk Gmbh Medizintechnologie9611612-2026-00020
- MEDLINEJul 16, 2026MalfunctionProductos Medline S.a. De C.v.1417592-2026-05838
- MEDLINEJul 16, 2026MalfunctionProductos Medline S.a. De C.v.1417592-2026-05835
- SPROTTE® 2.GJul 15, 2026InjuryPajunk Gmbh Medizintechnologie9611612-2026-00016
- TUOHY NRFITJul 15, 2026InjuryPajunk Gmbh Medizintechnologie9611612-2026-00018
- TuohyJul 15, 2026InjuryPajunk Gmbh Medizintechnologie9611612-2026-00015
Event type breakdown
Recalls
17 recall events for this product code
- ARROW INTERNATIONAL, LLCOpen, ClassifiedJun 13, 2026
Description/REF:
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Z-2389-2026 · View FDA record ↗ - Integra LifeSciences Corp. d.b.a. Integra Pain ManagementTerminatedJul 9, 2015
Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra Long Epidural Steroid
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).
Z-2056-2015 · View FDA record ↗ - Integra LifeSciences Corp. d.b.a. Integra Pain ManagementTerminatedApr 29, 2015
Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850.
A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles.
Z-1544-2015 · View FDA record ↗ - B. Braun Medical, Inc.TerminatedMay 28, 2014
Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer
B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.
Z-1666-2014 · View FDA record ↗ - RM Temena GmbHTerminatedMay 12, 2014
Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultras
Ultrasound needles may be defective and leak at the needle hub.
Z-1608-2014 · View FDA record ↗ - RM Temena GmbHTerminatedMay 12, 2014
Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under u
Ultrasound needles may be defective and leak at the needle hub.
Z-1609-2014 · View FDA record ↗ - Kyphon IncTerminatedFeb 5, 2008
Functional Anaesthetic Discography (F.A.D.) Catheter
Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure.
Z-0948-2008 · View FDA record ↗ - Kyphon IncTerminatedFeb 5, 2008
Kyphon, Functional Anaesthetic Discography (F.A.D.) Introducer Needle, Catalog Number: D01B, Kyphon, Inc., Sunnyvale, Ca 94089
Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure.
Z-0949-2008 · View FDA record ↗ - Becton Dickinson & CompanyTerminatedJun 25, 2005
BD 25G Spinal Needles. (Spinal Anesthesia Needle)
A significant level of 25G spinal needle hub leakage complaints was observed. Subsequent investigation found the leakage to be attributable to improper formation of the spinal needle hub, specifically an undersized taper and the prescence of a slight sink in the taper surface.
Z-0928-05 · View FDA record ↗ - B. Braun Medical, Inc.TerminatedSep 9, 2004
Standard and Custom Spinal Trays with 5% Lidocaine Hydrochloride 2 ml ampul
drug ampuls in kits contain particulates
Z-1439-04 · View FDA record ↗
Registered firms
360 firms currently registered for this product code
Teleflex Medical Llc
Morrisville, NC, US
Isomedix Operations, Inc.
Temecula, CA, US
Sterigenics U.s., Llc
Atlanta, GA, US
Icu Medical Healthcare Manufacturing S.a. De C.v.
Tijuana, B.C. C.P. Baja California, MX
Ningbo Linstant Polymer Materials Co.,ltd
Ningbo Zhejiang, CN
Medline Industries, Lp - Mexicali (mxc)
Mexicali Baja California, MX
Custom Tube Manufacturing Llc
Yangju-si Gyeonggi, KR
Pajunk Gmbh Medizintechnologie
GEISINGEN Baden-Wurttemberg, DE
Ych Distripark Sdn Bhd
Prai Pulau Pinang, MY
Carefusion 2200, Inc.
Vernon Hills, IL, US
Sterigenics U.s., Llc
Queensbury, NY, US
International Medical Development, Inc.
HUNTSVILLE, UT, US
Argon Medical Devices, Inc.
WHEELING, IL, US
Cbr Enterprise Limited
Hong Kong, HK
Eagle Labs, Llc
Saint Paul, MN, US
Jiangsu New Pentastar Medical Products Co. Ltd.
Changzhou Jiangsu, CN
B. Braun Melsungen Ag
MELSUNGEN Hesse, DE
Unisis Corp
Kita-Hiroshima-shi Hokkaido, JP
510(k) clearances
152 clearances for this product code
- PAJUNK GmbH MedizintechnologieJul 1, 2025
K243690 · SonoMSK
- PAJUNK GmbH MedizintechnologieJun 27, 2025
K243682 · SonoPlex STIM; SonoPlex II
- PAJUNK GmbH MedizintechnologieJun 25, 2025
K250774 · SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture
- PAJUNK GmbH MedizintechnologieMar 24, 2025
K243525 · SonoTAP and SonoTAP II
- PAJUNK GmbH MedizintechnologieNov 22, 2024
K241953 · SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology
- PAJUNK GmbH MedizintechnologieSep 11, 2024
K241954 · SonoBlock; SonoBlock II
- Aerin Medical, Inc.Mar 21, 2024
K240253 · Reach Needle
- Global Medikit LimitedJul 29, 2022
K212982 · Medispine - Spinal Needle, Glospine - Spinal Needle