Abbott AMO Vitrectomy Cutters Recalled for Packaging Error
Abbott Medical Optics is recalling 360 AMO Vitrectomy Cutters because 20GA and 25GA models may be packaged in the wrong sizes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because the source text identifies the issue as a 'Packaging error' with no reported injuries, illnesses, or deaths, fitting the rubric criteria for packaging-only problems.
Plain-English summary
Abbott Medical Optics Inc. (AMO) is recalling 360 units of AMO 25GA Vitrectomy Cutters (Model Number NGP0025) and AMO 20GA Vitrectomy Cutters and Irrigation Sleeves (Model Number NGP0020). These devices are used with the AMO Whitestar Signature System for ophthalmic use.
The recall is due to a packaging error where 20GA Vitrectomy Cutters may be found in a 25GA package, and 25GA Vitrectomy Cutters may be found in a 20GA package. The affected units include 72 units of Part Number NGP0025 (Lot CA06182) and 288 units of Part Number NGP0020 (Lot CA06180).
The products were distributed worldwide to South Africa, Turkey, Arizona, Netherlands, Portugal, Singapore, Australia, Japan, and Hong Kong. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these specific units.
The recalled product
- 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.
- Manufacturer
- Abbott Medical Optics Inc. (AMO)
- Hazard
- Affected units
- 360
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Abbott Medical Optics Inc. (AMO)
See all →- HighAbbott Recalls Healon Pro Due to Possible Glass Particles
FDA (Devices) · 2017-05-17
- HighAbbott Recalls Healon V Due to Possible Microscopic Glass Particles
FDA (Devices) · 2017-05-17
- HighAbbott Recalls Healon Medical Device Due to Glass Particle Risk
FDA (Devices) · 2017-05-17
- HighAbbott Recalls Healon GV Due to Possible Microscopic Glass Particles
FDA (Devices) · 2017-05-17
- HighAbbott Recalls Healon 5 Pro Due to Possible Glass Particles
FDA (Devices) · 2017-05-17
Same hazard · packaging error
See all →- ModerateTerumo Glidesheath Slender A-Kit Recalled for Incorrect Guidewire Packaging
FDA (Devices) · 2026-08-19
- LowRio II Nasal Pillows Interface Packaging and Labeling Discrepancy Recall
FDA (Devices) · 2026-07-22
- ModerateEMPOWR 3D KNEE insertion instruments recalled for incorrect product size packaging
FDA (Devices) · 2026-07-15
- ModerateArtegraft vascular graft recalled over incorrect lot outer packaging labeling
FDA (Devices) · 2026-03-25
- ModerateBD syringe batch may contain Luer Slip instead of Luer Lok
FDA (Devices) · 2026-03-18
Similar recalls
- ModerateRecall of 25GA Vitrectomy Cutters Due to Packaging Error
FDA (Devices) · 2019-07-10
- HighDutch Ophthalmic Vitrectomy Pack Contains Mismatched Infusion Line Gauge
FDA (Devices) · 2021-08-18
- HighCardiovascular Systems Recalls ViperWire Advance Guide Wires Due to Packaging Error
FDA (Devices) · 2017-05-03
- HighWindstone Medical Packaging Recalls Augmentation Mammoplasty Kits Due to Sterility Concerns
FDA (Devices) · 2016-10-26
- ModerateAbbott Recalls Mislabeled AMO Sensar Intraocular Lenses
FDA (Devices) · 2013-03-20
- HighWindstone Medical Recalls Laparoscopy Packs Due to Sterility Concerns
FDA (Devices) · 2016-10-26