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

Class I FDA enforcement event 99189. Recall start date: 21 May 2026. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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.

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Windstone Medical Packaging, Inc. started this device recall on 21 May 2026. The firm address in the FDA record is in Billings, MT. FDA put the recall in Class I. FDA event 99189 has 4 product records. The first FDA enforcement report date is 8 Jul 2026. The record gives the status Ongoing.

FDA enforcement report The 4 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide distribution in the states of PA, GA, CA, WA.

Recalling firm

Windstone Medical Packaging, Inc., Billings, MT.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

4 product records in the event.

FDA event 99189: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2619-2026	A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit	1080 kits	Class I	Ongoing	8 Jul 2026
Z-2620-2026	A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit	200 units	Class I	Ongoing	8 Jul 2026
Z-2621-2026	A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit	200 units	Class I	Ongoing	8 Jul 2026
Z-2622-2026	A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit	45 units	Class I	Ongoing	8 Jul 2026

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2026: 572
Share of these events in Class I: 12%
Product records in this event: 4Median of the firm: 3
Events of the firm on the register: 20

Other events of the firm

Other FDA enforcement events of Windstone Medical Packaging, Inc.
Initiated	Product (first record)	Type	Class	Records
29 Jul 2026	AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B	Device	Class II	1
17 Jun 2026	AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A	Device	Class II	8
8 Jun 2026	AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part	Device	Class II	4
27 Apr 2026	Aligned Medical AMS16835 Fluids Kit RX	Device	Class II	1
2 Apr 2026	Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA S	Device	Class I	1
11 Mar 2026	Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433	Device	Class II	3
16 Aug 2024	Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a c	Device	Class II	5
22 Dec 2023	Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO	Device	Class I	4
24 Apr 2023	Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO	Device	Class II	3
1 Nov 2022	Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS104	Device	Class II	1

Windstone Medical Packaging, Inc.: all 20 events

Official channels

FDA enforcement report Z-2619-2026The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 99189. https://recallregister.com/fda/i/99189/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide distribution in the states of PA, GA, CA, WA.
What quantity of product is in FDA event 99189?: The event has 4 product records. The first record gives this quantity: 1080 kits
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2026 have the same class?: 12% of the 572 device events that started in 2026 are in Class I.