The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1790-2017·Announced 2017-04-19

Windstone Eye Cataract Kits Recalled for Sterile Packaging Compromise

Windstone Medical Packaging is recalling Eye Cataract Packs because the sterile packaging of the included eye pad may be compromised.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (compromised sterile packaging) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling Eye Cataract Packs, part numbers AMS1359 and AMS1359-1. The recall involves 1,520 kits that were distributed nationwide to locations in California, Colorado, Florida, Georgia, Iowa, Kentucky, Massachusetts, Minnesota, Missouri, North Dakota, New Jersey, Nevada, Ohio, South Dakota, Texas, Utah, Wisconsin, and Wyoming.

The recall was initiated due to the potential for the sterile packaging of the Medtronic Covidien Curity Eye Pad included in the kits to be compromised. The agency has classified this as a Class II recall.

Healthcare providers and consumers should stop using the affected kits and contact Windstone Medical Packaging, Inc. for further instructions or a replacement.

The recalled product

Product
Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a convenient manner for use in a general clinical procedure
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
1,520

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Part of a larger recall action

This product is one of 18 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 18 products in this recall →

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