Syringe, Piston
FDA adverse event reports and recall history for syringe, piston (product code FMF), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 52,412
- Deaths
- 66
- Injuries
- 5,189
- Malfunctions
- 46,395
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
- 2026-06-26Open, ClassifiedProcess control
SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Piston
A single lot of expired syringes were distributed due to a distribution system control failure.
- 2026-06-13Open, ClassifiedNonconforming Material/Component
Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-04711
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.
- 2026-04-02Open, ClassifiedUnder Investigation by firm
Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.
- 2026-03-06Open, ClassifiedUnder Investigation by firm
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case.
During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
- 2025-06-20Open, ClassifiedProcess change control
Extended Tip Applicator, 8CM, Box of 5.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
- 2025-06-20Open, ClassifiedProcess change control
Extended Tip Applicator, 15 CM, Box of 5.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
- 2025-06-20Open, ClassifiedProcess change control
Extended Tip Applicator 8CM, Box of 1.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
- 2025-06-20Open, ClassifiedProcess change control
MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.
Lack of sterility assurance.
- 2025-06-12Open, ClassifiedProcess control
BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
- 2025-06-12Open, ClassifiedProcess control
BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006
Sterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male luer component and the needle-free connector, which may cause procedure delay, treatment interruptions, exposure to hazardous drugs, and/or underdosing of medication.
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