FDA Device Intelligence
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Syringe, Irrigating (Non Dental)

FDA product code KYZ · Class 1 · General Hospital

450
Registered devices
586
Adverse events
20
Recalls
41
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-06-30Boston Scientific CorporationDevices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifo
2024-01-04MEDLINE INDUSTRIES, LP - NorthfieldPackaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the ste
2023-12-04Cardinal Health 200, LLCConvenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
2022-12-07MEDLINE INDUSTRIES, LP - NorthfieldThe recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are st
2018-02-06Baxter Healthcare CorporationAffected lot of 5 mL oral dispensers was packaged in individual pouches that are mislabeled with the incorrect product code (H93876101) and volume (1mL).
2017-12-19Cook Inc.Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may
2017-06-01Shippert Medical TechnologiesSeal integrity of the Tissu-Trans product sterile packages cannot be assured.
2017-06-01Shippert Medical TechnologiesSeal integrity of the Tissu-Trans product sterile packages cannot be assured.
2016-08-03C.R. Bard, Inc.Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.
2016-08-03C.R. Bard, Inc.Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.

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