FDA Device Intelligence
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Syringe, Piston

FDA product code FMF · Class 2 · General Hospital

5,997
Registered devices
52,759
Adverse events
305
Recalls
750
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-04-28Mentor Texas LPA single lot of expired syringes were distributed due to a distribution system control failure.
2026-04-21ARROW INTERNATIONAL, LLCLidocaine, 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 iss
2026-02-27Cardinal Health 200, LLCThe outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained
2026-01-27Becton Dickinson & CompanyDuring the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
2025-05-23Integra LifeSciences Corp. (NeuroSciences)Lack of sterility assurance.
2025-05-22Integra LifeSciences Corp. (NeuroSciences)Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
2025-05-22Integra LifeSciences Corp. (NeuroSciences)Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
2025-05-22Integra LifeSciences Corp. (NeuroSciences)Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
2025-05-12BD SWITZERLAND SARLSterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male lu
2025-05-12BD SWITZERLAND SARLSterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the closed male lu

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.