Needle, Aspiration And Injection, Disposable
FDA adverse event reports and recall history for needle, aspiration and injection, disposable (product code GAA), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,778
- Deaths
- 1
- Injuries
- 333
- Malfunctions
- 1,402
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
- 2023-09-19TerminatedDevice Design
TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
- 2023-09-19TerminatedDevice Design
TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-310
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
- 2023-09-19TerminatedDevice Design
TyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-317
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
- 2022-10-07Open, ClassifiedProcess control
Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2022-10-07Open, ClassifiedProcess control
Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
- 2015-08-10TerminatedDevice Design
Perfectum Tuberculin Glass Syringe, Non sterile Catalog numbers 5202, 5205, 5212
Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.
- 2015-08-10TerminatedDevice Design
Micro-Mate Tuberculin Glass Syringe, Non-sterile Catalog numbers 5208, 5209
Graduation marks of the syringe are not centered with the numeric position marks on the syringe barrel.
- 2013-08-27TerminatedNo Marketing Application
SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.
- 2011-02-08TerminatedEmployee error
Inrad sample master aspiration biopsy needle with hiliter sharp bevel needle, 22 ga x 2 3/8'' (6 cm), model 41222, Inrad, Inc. Kentwood, MI. The device is intended for use during percutaneous biopsy and drainage procedures to obtain tissues or fluid specimens.
This lot of product has the wrong expiration date on the carton label. The pouches contained the correct expiration date.
- 2010-10-07TerminatedPending
BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
There have been reports of blocked/clogged needles for the 30 gauge PrecisionGlide Needles
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