RecallReported September 16, 2026
Class II recall by Windstone Medical Packaging, Inc.
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
FDA's enforcement report of September 16, 2026 lists a Class II recall by Windstone Medical Packaging, Inc. of Billings, MT. Product: AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B. Status: Ongoing.
On the record
- Recalling firm
- Windstone Medical Packaging, Inc.
- Location
- Billings, MT
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-3138-2026
- Product type
- Devices
- Recall initiated
- 2026-07-29
- Reported by FDA
- 2026-09-16
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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