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V. Mueller

STERIS CORPORATION · Model OS5000-003 · UDI-DI 10885403105166

GEA Prescription

510(k) clearances

1,037

Adverse events (1 deaths)

Recalls

377

Facilities

Description

CRAIG CALIBRATED BLUNT TROCAR ONLY FOR CRAIG BIOPSY SET OVERALL LENGTH 10 inches25.4CM

Recalls

Date	Firm	Reason
2024-12-03	Sklar Instruments	Reports of various packaging issues that may result in a breach of the sterile barrier.
2021-04-01	CLINICAL LASERTHERMIA SYSTEMS AB	single use devices labeled as sterile may not have been adequately sterilized
2020-01-15	Cardinal Health 200, LLC	Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile
2019-07-16	TeDan Surgical Innovations LLC	There was incorrect raw material used in the production of the identified lot.
2018-08-21	Genicon, Inc.	There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21	Genicon, Inc.	There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21	Genicon, Inc.	There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21	Genicon, Inc.	There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21	Genicon, Inc.	There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21	Genicon, Inc.	There is potential for the plastic optical tip to become detached from the metal shaft.

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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.