Needle, Conduction, Anesthetic (W/Wo Introducer)
FDA adverse event reports and recall history for needle, conduction, anesthetic (w/wo introducer) (product code BSP), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,295
- Deaths
- 3
- Injuries
- 376
- Malfunctions
- 807
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-06-13Open, ClassifiedNonconforming Material/Component
Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANESTHESIA KIT/ASA-25090-SB; SPINAL ANESTHESIA KIT: 24 GA X 9 CM/ASK-24090-SA; SPINAL ANESTHESIA KIT: 25 GA X 9 CM/ASK-24090-SPH; SPINAL ANESTHESIA KIT/ASK-25090-BIDMC; SPINAL ANESTHESIA KIT/ASK-25090-UF
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.
- 2015-07-09TerminatedLabeling design
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.
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).
- 2015-04-29TerminatedEmployee error
Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850. Used to administer steroid medication in the epidural space.
A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles.
- 2014-05-28TerminatedNonconforming Material/Component
Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia
B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.
- 2014-05-12TerminatedProcess design
Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultrasound guidance.
Ultrasound needles may be defective and leak at the needle hub.
- 2014-05-12TerminatedProcess design
Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance
Ultrasound needles may be defective and leak at the needle hub.
- 2008-02-05TerminatedLabeling design
Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca 94089
Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure.
- 2008-02-05TerminatedLabeling design
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.
- 2005-06-25TerminatedOther
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.
- 2004-09-09TerminatedOther
Standard and Custom Spinal Trays with 5% Lidocaine Hydrochloride 2 ml ampul
drug ampuls in kits contain particulates
Monitor needle, conduction, anesthetic (w/wo introducer) automatically
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