Aligned Medical Solutions DSAEK Pack-RX Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Windstone Medical Packaging, Inc. recalls 1080 AMS DSAEK Pack-RX surgical kits distributed nationwide due to potential contamination.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 8, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Which Products Are Affected
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit. 1080 kits. Distribution in the states of PA, GA, CA, WA. Lot Codes: 237663, 237901, 237957, 238041, 238084, 238085, 238146, 238197, 238589, 239157, 239216, 239286, 239337, 239386, 239943, 240269, 240633, 240705, 240903, 240904, 241034, 241223, 241224, 241313. Recall number Z-2619-2026. Class I recall initiated May 21, 2026.
What You Should Do
Check lot codes against the listed codes. Affected products were distributed by Windstone Medical Packaging, Inc. of Billings, MT.
Why This Matters
This is a Class I recall involving 1080 kits with potential microbial contamination.
Source
FDA recall Z-2619-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (958 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 8, 2026.
Frequently Asked Questions
Common questions about this FDA recall.