| | Class 2 Device Recall AMS ALIGNED MEDICAL SOLUTIONS |  |
| Date Initiated by Firm | June 08, 2026 |
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| Date Posted | July 24, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2802-2026 |
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| Recall Event ID |
99323 |
| Product Classification |
Orthopedic tray - Product Code OJH
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| Product | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) Laminectomy Pack, Pack Number AMS13574A;
2) ACDF/Fusion Pack, Pack Number AMS14710B;
3) Spine Pack, Pack Number AMS14991A;
4) Spine Pack, Pack Number AMS14991B;
5) Spinal Pack, Pack Number AMS16278;
6) Spine Pack, Pack Number AMS16499;
7) Spine Pack, Pack Number AMS16709;
8) Lumbar Spine Pack, Pack Number AMS17336;
9) Laminectomy Pack, Pack Number AMS17945;
10) Anterior Cervical Pack, Pack Number AMS17946;
11) Spine Pack, Pack Number AMS3150F;
12) Spine Pack, Pack Number AMS3150G;
13) Spine Pack, Pack Number AMS5451D;
14) ENT Pack, Pack Number AMS9771. |
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| Code Information |
1) Pack Number AMS13574A, UDI B098AMS13574A0, Lot Numbers: 235911, 236897.
2) Pack Number AMS14710B, UDI B098AMS14710B0, Lot Numbers: 224717, 230666, 213914, 236351.
3) Pack Number AMS14991A, UDI B098AMS14991A0, Lot Numbers: 215450, 230108.
4) Pack Number AMS14991B, UDI B098AMS14991B0, Lot Numbers: 233346.
5) Pack Number AMS16278, UDI B098AMS162780, Lot Numbers: 219872, 222999, 226497, 229309, 236465, 237544, 238613.
6) Pack Number AMS16499, UDI B098AMS164990, Lot Numbers: 215711, 218234, 224253, 226168, 226627, 227667, 228446, 230422, 233097, 233399, 233960, 234577, 234907, 236220, 236852, 237358, 238563, 239114, 240373, 241010, 241717.
7) Pack Number AMS16709, UDI B098AMS167090, Lot Numbers: 223361, 225039, 236666, 240344, 241412.
8) Pack Number AMS17336, UDI B098AMS173360, Lot Numbers: 233541, 240967.
9) Pack Number AMS17945, UDI B098AMS179450, Lot Numbers: 235478, 240779, 241565.
10) Pack Number AMS17946, UDI B098AMS179460, Lot Numbers: 235954, 239092, 241514.
11) Pack Number AMS3150F, UDI B098AMS3150F0, Lot Numbers: 211888, 216076, 216357, 218443, 219827, 221799, 223766, 227324,
228151, 229404, 229717, 230623, 231694, 233211, 234586, 234763, 236581, 241332.
12) Pack Number AMS3150G, UDI B098AMS3150G0, Lot Numbers: 242374.
13) Pack Number AMS5451D, UDI B098AMS5451D0, Lot Numbers: 222621, 224568, 238089, 238575, 242113.
14) Pack Number AMS9771, UDI B098AMS97710, Lot Numbers: 176784, 179837, 181956, 184890, 191784, 194017, 196708, 197543,
199137, 201956, 210134, 215434, 217352, 218696, 225332, 226657, 228224, 228678, 230472, 233592, 235614, 236684, 241927. |
| FEI Number |
1000125955
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Recalling Firm/
Manufacturer |
Windstone Medical Packaging, Inc.
1602 4th Ave N
Billings MT 59101-1521
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| For Additional Information Contact |
406-259-6387 |
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Manufacturer Reason
for Recall | The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products. |
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FDA Determined
Cause 2 | Material/Component Contamination |
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| Action | Aligned Medical Solutions (AMS) issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 6/8/2026 via email. The notice explained the issue, potential risk, and requested the following actions: identify and quarantine affected product, affix the sticker which reads: "RECALL NOTICE
Medicom announced the recall of Ritmed Neurological Sponges contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall."
" At the time the kit is opened for use any Medicom-Ritmed Neurological Sponges should be identified and set aside.
" The recalled Medicom-Ritmed Neurological Sponges should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution. Complete the recall reply form and return it via email to: fieldcorrectiveaction@alignedmedical.com even if you have no affected product on hand.
Those further distributing the product were directed to notify their distribution partners.
For questions contact fieldcorrectiveaction@alignedmedicalsolutions.com. |
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| Quantity in Commerce | 7306 units |
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| Distribution | US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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