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MONDEAL

MONDEAL Medical Systems GmbH · Model 77-TA4-3004 · UDI-DI 04050435117602

FMS Prescription

510(k) clearances

1,272

Adverse events (2 deaths)

Recalls

Facilities

Description

Basket complete incl. 4 silicone instrument racks and lid 273 x 84 x 41

Recalls

Date	Firm	Reason
2026-02-18	Stryker Medical Division of Stryker Corporation	Cribs sold in the USA are missing two access door warning labels.
2021-05-12	Stryker Medical Division of Stryker Corporation	Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately iden
2019-07-03	PediaLift LLC	The firm was unsuccessful in obtaining a satisfactory Certificate of Conformance from the original vendor of the mattress showing that they are in compliance with labeling require
2003-12-19	Hill-Rom, Inc.	The caster/wheel may come off of the bassinet, causing the bassinet to tip.
2003-12-19	Hill-Rom, Inc.	The caster/wheel may come off of the bassinet, causing the bassinet to tip.

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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.