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DeRoyal

DEROYAL INDUSTRIES, INC. · Model 30-0705NS · UDI-DI 00749756586641

MMP

510(k) clearances

Adverse events

Recalls

Facilities

Description

Microscope Drape

Recalls

Date	Firm	Reason
2023-05-18	MEDLINE INDUSTRIES, LP - Northfield	Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
2023-05-15	MEDLINE INDUSTRIES, LP - Northfield	Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
2020-01-07	Stryker Corporation	Sterile drapes packaged in an unsealed pouch.
2020-01-07	Stryker Corporation	Sterile drapes packaged in an unsealed pouch.
2017-06-27	NOVADAQ TECHNOLOGIES INC.	The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
2017-06-27	NOVADAQ TECHNOLOGIES INC.	The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
2017-06-27	NOVADAQ TECHNOLOGIES INC.	The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
2017-01-23	Covidien LLC	Sterility compromised due to breach in sterile barrier
2017-01-23	Covidien LLC	Sterility compromised due to breach in sterile barrier
2015-02-11	Sybron Dental Specialties	Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associate

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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.