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SURGICAL PROCEDURE PACK

OMNIA SRL · Model 12.XYYYY.00 · UDI-DI 08056646500222

LRO KKX FYA FXX Prescription

510(k) clearances

20,596

Adverse events (2 deaths)

1,057

Recalls

158

Facilities

Description

Indication For Use: Surgical Procedure Packs is a kit for oral implantology, used by dental professionals when performing surgical procedures. Surgical Procedure Packs are composed of disposable devices intended for professional use in preparing the operating environment with protective coverings and clothes that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries. Surgical Procedure Packs may be packages as a combination of any of the following components: - Surgical gowns (various models) with or without hand towels - Surgical Drapes: - Mayo drape - Absorbent/liquid proof drapes (with or without adhesive) - Adhesive side drape - Liquid repellent drape with or without adhesive - Face mask - Protective caps - Sheath/tubing sleeve - Surgical aspirator with adaptor - Surgical gauze - Disinfection sponge and/or basin - Adhesive films - Syringe - Needles - Single-use scalpel - Small dental mirror/dental explorer/tweezer - Irrigation/infusion line - Stopcock and ramp for infusion - Waste bag for contaminated material - Bone collector - Saliva ejector - Basin - Medical paper 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.