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KYWClass 1

Container, Liquid Medication, Graduated

FDA adverse event reports and recall history for container, liquid medication, graduated (product code KYW), from the public MAUDE/AEMS corpus and the live FDA recall database.

Total reports
209
Deaths
0
Injuries
18
Malfunctions
185

Reports per year

07
10
11
15
16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 2007–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

  • 2025-11-14Open, ClassifiedUnder Investigation by firm

    BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;

    BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.

  • 2024-09-06Open, ClassifiedOther

    Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A

    Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

  • 2022-10-20Open, ClassifiedNonconforming Material/Component

    Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD

    Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

  • 2022-10-20Open, ClassifiedNonconforming Material/Component

    Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05

    Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

  • 2022-10-20Open, ClassifiedNonconforming Material/Component

    Medicina Oral Tip Syringe 0.5ml Code: OT005

    Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

  • 2022-10-20Open, ClassifiedNonconforming Material/Component

    Medicina Oral Tip Syringe 1ml Code: OT01

    Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

  • 2022-10-20Open, ClassifiedNonconforming Material/Component

    Medicina Oral Tip Syringe 2.5ml Code: OT25

    Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

  • 2022-10-20Open, ClassifiedNonconforming Material/Component

    Medicina Reusable Oral syringe 1ml Code: OTH01

    Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

  • 2022-10-20Open, ClassifiedNonconforming Material/Component

    Medicina Reusable Oral syringe 5ml Code: OTH05

    Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

  • 2022-10-20Open, ClassifiedNonconforming Material/Component

    Medicina Reusable Oral syringe 2.5ml Code: OTH25

    Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

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