The Recall Desk
HighFDA (Devices)·Z-1794-2017·Announced 2017-04-19

Windstone Medical Ophthalmic Packs Recalled for Sterile Packaging Compromise

Windstone Medical Packaging is recalling 169 ophthalmic packs containing Medtronic Curity Eye Pads because the sterile packaging may be compromised.

What this means for you

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 involves a risk-of-harm product (compromised sterile packaging) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 169 Ophthalmic Packs, part numbers WAL1107(A and WAL1190, which contain Medtronic Covidien Curity Eye Pads. The recall is due to the potential for the sterile packaging of the eye pads to be compromised.

The affected products were distributed nationwide, including in California, Colorado, Florida, Georgia, Iowa, Kentucky, Massachusetts, Minnesota, Missouri, North Dakota, New Jersey, Nevada, Ohio, South Dakota, Texas, Utah, Wisconsin, and Wyoming. The specific lot numbers involved are 87223, 88773, 89837, 95552, 97215, 97765, 100154, 100984, and 102837.

Healthcare providers and consumers should stop using these products and contact Windstone Medical Packaging for further instructions or a return.

The recalled product

Product
Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure
Affected units
169

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 →