FDA Medical devices recall ·
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1)… recall
- Recall number
- Z-2802-2026
- Date
- (initiated June 8, 2026)
- Company / brand
- Windstone Medical Packaging, Inc.
1602 4th Ave N, Billings, MT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7306 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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, 217
Distribution
US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
States: Arizona California Connecticut Georgia Illinois Massachusetts Maryland New York Ohio Pennsylvania Tennessee Texas Virginia Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2802-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.