Data Foundry

Medical device recalls 2017

AMO 25GA Vitrectomy Cutter — Class II medical device recall Z-2096-2017

Terminated recall by Abbott Medical Optics Inc. (AMO), reported 2017-05-24, distributed in AZ. Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be fou

Recall numberZ-2096-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmAbbott Medical Optics Inc. (AMO), Santa Ana, CA, United States
Recall initiated2017-03-30
Classified2017-05-16
Reported by FDA2017-05-24
Terminated2017-08-23
DistributedAZ
Quantity360 units
Lot numbersCA06180, CA06182
Model numbersNGP0020, NGP0025

Product

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2096-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.