FDAFDA recall Z-2802-2026 · Aug 5, 2026

Windstone Medical Packaging, Inc.: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack recall

Recall found

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.

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.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status: Ongoing
Codes, lots and dates: 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.
Quantity: 7306 units
Distribution: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
Recalling firm: Windstone Medical Packaging, Inc., Billings, MT
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-06-08

Source: openFDA enforcement record Z-2802-2026 · search recall number Z-2802-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.