Introducer, Syringe Needle
FDA adverse event reports and recall history for introducer, syringe needle (product code KZH), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,079
- Deaths
- 1
- Injuries
- 238
- Malfunctions
- 829
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
- 2015-04-02TerminatedProcess control
Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs as prescribed by their doctor.
The syringe carrier is missing components: a damper and spring.
- 2011-11-07TerminatedLabeling mix-ups
1.0mL 28 G x 1/2" blister packaged insulin syringe Catalog Number 329424; Lot Number 0039920 Intended use: Subcutaneous injection of insulin.
Experiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes.
- 2005-04-08TerminatedOther
Centurion brand sterile Huber needle infusion set, 20 GA x 1 inch; product EXHN010S.
Some of the needles in these sets are 3/4 inches in length instead of the labeled 1 inch.
- 2003-11-01TerminatedOther
Arrow Howes multi-lumen central venous catheterization kit 7 Fr x 20 cm
wrong product in box
- 2003-11-01TerminatedOther
Arrow central venous catheterization kit, 14 ga x 20 cm
wrong product in box
- 2003-11-01TerminatedOther
Cannon catheter hemodialysis catheterization set, 15 Fr x 36 cm
wrong product in box
- 2003-11-01TerminatedOther
10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set
package lid identifies the contents incorrectly
- Open, ClassifiedEmployee error
Autoject EI, REF AJ1310
There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches V14.V976 & V14.W107
- Open, ClassifiedEmployee error
Petfine Auto Injector, REF 3310VET
There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches V14.V976 & V14.W107
- TerminatedUnder Investigation by firm
Syringe Bulb, 60 CC 50 pcs per case. The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body.
Insufficient documentation to support product sterility claims.
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