Home › Device types › KDD
Kit, Surgical Instrument, Disposable
FDA product code KDD · Class 1 · General, Plastic Surgery
0
Registered devices
579
Adverse events
252
Recalls
62
510(k) clearances
Devices with this code
Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.EKCOMED — Ekcomed, Inc.Disposable Kit for MIRO Procedure Gmreis — GM DOS REIS INDUSTRIA E COMERCIO LTDACustomEyes® — Beaver-Visitec International, Inc.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC. — MEDLINE INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.CustomEyes® — Beaver-Visitec International, Inc.CustomEyes® — Beaver-Visitec International, Inc.SegWAY ECTR-d — TRICE MEDICAL, INC.DeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.Readypak Kit — Beaver-Visitec International, Inc.Y-Knot — Conmed CorporationBioseal Inc. — BIOSEALJones/5th Metatarsal Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS LLCCustomEyes® — Beaver-Visitec International, Inc.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Custom Healthcare Systems Inc. — Manus Medical, LLCCustom Healthcare Systems Inc. — Manus Medical, LLCDeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-02 | Medline Industries, LP | Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaki |
| 2026-07-29 | Windstone Medical Packaging, Inc. | The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have |
| 2026-07-20 | Medline Industries, LP | Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the |
| 2026-05-21 | Medline Industries, LP | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocai |
| 2026-05-04 | Medline Industries, LP | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie |
| 2026-04-21 | ARROW INTERNATIONAL, LLC | 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 iss |
| 2026-03-19 | Medline Industries, LP | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market |
| 2026-03-11 | Windstone Medical Packaging, Inc. | The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump |
| 2026-03-11 | Windstone Medical Packaging, Inc. | The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump |
| 2026-03-11 | Windstone Medical Packaging, Inc. | The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump |
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