Urgent site urgencyFDA Class I

A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit

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.

Agency
FDA Device
Recall date
May 21, 2026
Status
Ongoing
Company
Windstone Medical Packaging, Inc.

1. What product was recalled?

A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit

A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit

Quantity: 1080 kits

Code or lot text: UDI/DI none, 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.

LOT
237901
LOT
237957
LOT
238041
LOT
238084
LOT
238085
LOT
238146
LOT
238197
LOT
238589
LOT
239157
LOT
239216
LOT
239286
LOT
239337
LOT
239386
LOT
239943
LOT
240269
LOT
240633
LOT
240705
LOT
240903
LOT
240904
LOT
241034
LOT
241223
LOT
241224
LOT
241313.
LOT
Lot Codes: 237663
LOT
UDI/DI none
RECALL-NUMBER
Z-2619-2026

A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit

A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit

Quantity: 200 units

Code or lot text: UDI/DI none, 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.

LOT
237901
LOT
237957
LOT
238041
LOT
238084
LOT
238085
LOT
238146
LOT
238197
LOT
238589
LOT
239157
LOT
239216
LOT
239286
LOT
239337
LOT
239386
LOT
239943
LOT
240269
LOT
240633
LOT
240705
LOT
240903
LOT
240904
LOT
241034
LOT
241223
LOT
241224
LOT
241313.
LOT
Lot Codes: 237663
LOT
UDI/DI none
RECALL-NUMBER
Z-2621-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

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.

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

View source evidence for state distribution
  • California: US Nationwide distribution in the states of PA, GA, CA, WA.
  • Georgia: US Nationwide distribution in the states of PA, GA, CA, WA.
  • Pennsylvania: US Nationwide distribution in the states of PA, GA, CA, WA.
  • Washington: US Nationwide distribution in the states of PA, GA, CA, WA.

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

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10. Where is the official source?

Open the official FDA Device source

The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.