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Obstetrical Kit

FDA product code OKV · Class 2 · Obstetrics/Gynecology

8,543
Registered devices
22
Adverse events
91
Recalls
0
510(k) clearances

Devices with this code

Halyard — AVID MEDICAL, INC.Halyard — AVID MEDICAL, INC.CARDINAL HEALTH — Cardinal Health 200, LLCMEDLINE INDUSTRIES, INC. — MEDLINE INDUSTRIES, INC.Halyard — AVID MEDICAL, INC.Halyard — AVID MEDICAL, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Halyard — AVID MEDICAL, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.Halyard — AVID MEDICAL, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.AVID TruCustom — AVID MEDICAL, INC.AVID TruCustom — AVID MEDICAL, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCHalyard — AVID MEDICAL, INC.AVID TruCustom — AVID MEDICAL, INC.AVID TruCustom — AVID MEDICAL, INC.AVID TruCustom — AVID MEDICAL, INC.Halyard — AVID MEDICAL, INC.AVID TruCustom — AVID MEDICAL, INC.Halyard — AVID MEDICAL, INC.Halyard — AVID MEDICAL, INC.AVID TruCustom — AVID MEDICAL, INC.

Recent recalls

DateFirmReason
2026-07-10AVID Medical, Inc.A customer complaint reported that the Clearify Visualization System (5303907) leaked in a kit. As a result of Avid s investigation, it was determined that the
2026-07-10Medline Industries, LPKits contain a potentially contaminated component which were recalled by the manufacturer
2026-06-08Medline Industries, LPAffected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the sur
2026-05-04Medline Industries, LPDuring an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularitie
2026-04-27Medline Industries, LPKits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for applicat
2026-03-19Medline Industries, LPDuring an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market
2026-02-25Medline Industries, LPThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
2026-01-07Medline Industries, LPMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster
2026-01-07Medline Industries, LPMedline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster
2025-12-16Medline Industries, LPMedline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and

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