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AESCULAP

AESCULAP, INC. · Model MD569 · UDI-DI 04046963365578

HTD Prescription

510(k) clearances

2,217

Adverse events (1 deaths)

Recalls

667

Facilities

Description

Dissecting Forceps, angled, 90 °, 5 1/2", (140 mm), non-sterile, reusable

Recalls

Date	Firm	Reason
2025-01-31	Aesculap Inc	The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
2024-12-03	Sklar Instruments	Reports of various packaging issues that may result in a breach of the sterile barrier.
2022-07-25	Stradis Medical, LLC dba Stradis Healthcare	The sterile barrier may be compromised.
2022-07-25	Stradis Medical, LLC dba Stradis Healthcare	The sterile barrier may be compromised.
2019-01-09	ConvaTec, Inc	An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
2018-11-02	Baxter Healthcare Corporation	Potential presence of rust on Coupler Forceps (GEM4183C).
2013-11-26	Biomet, Inc.	Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium.
2013-11-20	Edwards Lifesciences, LLC	Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scissors standard curved labeled as a Double Acting DeBakey forcep. Edwards control con
2009-09-03	Synthes USA (HQ), Inc.	The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.
2009-09-03	Synthes USA (HQ), Inc.	The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.

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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.