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Implant Kit

OMNIA SRL · Model 12.XYYYY.00 · UDI-DI 08056646500840

LRO KKX FYA FXX Prescription

510(k) clearances

20,596

Adverse events (2 deaths)

1,057

Recalls

158

Facilities

Description

The sterile "Procedural Packages for Diagnosis and Surgery" are intended for use by specialized personnel and are composed of consumables and devices intended for the preparation of the operating field, maintenance of cleanliness (ensuring the hygiene of the field and limiting the risk of contamination) and the performance of various types of surgery. The devices provided can be: - non-invasive devices, for the preparation of the operating field - for example: drapes, gowns, masks and accessories (bandages, sheaths, tool pockets, bags for collecting liquids, fixed pliers for drapes, etc.) - invasive surgical devices for temporary use not in contact with the central circulatory system and with the nervous system - for example: needles and syringes with needle, disposable scalpels and gauze. - devices for channeling liquids intended for irrigation. Possible combination of any of the devices mentioned are identified with different UDI code listed in the section "Package DI" Model number : X = alphabetic character YYYY=n° of 4 number character.

Recalls

Date	Firm	Reason
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 packaging of the ap
2026-07-14	Cardinal Health 200, LLC	Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability o
2026-07-10	Medline Industries, LP	Kits contain a potentially contaminated component which were recalled by the manufacturer
2026-07-09	AVID Medical, Inc.	Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
2026-07-09	AVID Medical, Inc.	Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
2026-07-09	AVID Medical, Inc.	Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
2026-07-09	AVID Medical, Inc.	Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
2026-07-09	AVID Medical, Inc.	Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
2026-07-09	AVID Medical, Inc.	Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
2026-07-09	AVID Medical, Inc.	Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.