Abbott Medical Optics Inc. (AMO): Medical Device Recall in 2017 - (Recall #: Z-2096-2017)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2017.
Data Source: FDA.
Product Description:
AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.
Product Classification:
Class II
Date Initiated: March 30, 2017
Date Posted: May 24, 2017
Recall Number: Z-2096-2017
Event ID: 77024
Reason for Recall:
Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package.
Status: Terminated
Product Quantity: 360 units total
Code Information:
Part Number NGP0025 Lot CA06182 (72 units) Part Number NGP0020 Lot CA06180 (288 units)
Distribution Pattern:
Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK.
Voluntary or Mandated:
Voluntary: Firm initiated