Dutch Ophthalmic USA, Inc. FDA Recalls

2 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALCClass IIApr 14, 2021Barcode label extended expiration date. Barcode located at t	Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 wh	Class IIDevices	Apr 14, 2021
Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeledClass IIFeb 25, 2021Mislabeled: 1281.B1D Disposable Replacement Backflush Brush	Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 mm) instead of	Class IIDevices	Feb 25, 2021