AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack,
Summary
The FDA issued a Class II for AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pac by Windstone Medical Packaging, Inc.. Reason: The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-.
Details
Source
Device Recall
External ID
Z-2799-2026
Action Date
2026-08-05
Status
Ongoing
Category
device
Product Description
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part Number AMS10411C; 3) Rhinoplasty Pack, Part Number AMS11963A; 4) Spine Pack, Part Number AMS12636C; 5) Lumbar Lami Pack, Part Number AMS12731; 6) Septoplasty Pack, Part Number AMS13150; 7) Septoplasty Pack, Part Number AMS13150A; 8) Septoplasty Pack, Part Number AMS13150B; 9) Rhinoplasty Pack, Part Number AMS14496A; 10) Rhinoplasty Pack, Part Number AMS14496B; 11) Rhinoplasty Pack, Part Number AMS14496C; 12) Laryngoscopy Pack, Part Number AMS14736; 13) Nasal and Sinus Pack, Part Number AMS16417; 14) Major Pack, Part Number AMS16586; 15) Major Pack, Part Number AMS16586A; 16) Nasal and Sinus Pack, Part Number AMS7619A; 17) Sinus Pack, Part Number AMS7819A.
Lot/Code Info: 1) Pack Number AMS10411B, UDI B098AMS10411B0, Lot Numbers: 219316, 221418, 225796, 227963, 229410, 231465, 232835, 234875, 236009. 2) Pack Number AMS10411C, UDI B098AMS10411C0, Lot Numbers: 237159, 239012. 3) Pack Number AMS11963A, UDI B098AMS11963A0, Lot Numbers: 219232, 221841, 231180, 233233, 235232, 237047, 239415. 4) Pack Number AMS12636C, UDI B098AMS12636C0, Lot Numbers: 216052, 216353, 219607, 222572, 227336, 228169, 232135, 232908, 236235, 242190. 5) Pack Number AMS12731, UDI B098AMS127310, Lot Numbers: 211494, 219640, 224583, 225855, 226678, 228322, 231368, 241824. 6) Pack Number AMS13150, UDI B098AMS131500, Lot Numbers: 172113, 190090, 196504, 197866, 199463, 199844, 201971. 7) Pack Number AMS13150A, UDI B098AMS13150A0, Lot Numbers: 202549, 204081, 209263, 210230, 211511, 213173, 215672. 8) Pack Number AMS13150B, UDI B098AMS13150B0, Lot Numbers: 216273, 216809, 218664, 219473, 222602, 224670, 225793, 227885, 229995, 232849, 234167, 235630, 236695, 237697, 239909, 241667. 9) Pack Number AMS14496A, UDI B098AMS14496A0, Lot Numbers: 207772, 219739. 10) Pack Number AMS14496B, UDI B098AMS14496B0, Lot Numbers: 223681, 224699, 226316, 227598. 11) Pack Number AMS14496C, UDI B098AMS14496C0, Lot Numbers: 231376, 237310. 12) Pack Number AMS14736, UDI B098AMS147360, Lot Numbers: 192735, 204268, 222714, 226621. 13) Pack Number AMS16417, UDI B098AMS164170, Lot Numbers: 217216, 219433, 219463, 229357, 235439, 237701, 241666. 14) Pack Number AMS16586, UDI B098AMS16586, Lot Numbers: 229154, 230255. 15) Pack Number AMS16586A, UDI B098AMS16586A0, Lot Numbers: 233268, 233269, 233688, 233689, 235659, 236978, 237621, 238623, 239249, 241987. 16) Pack Number AMS7619A, UDI B098AMS7619A0, Lot Numbers: 176227, 179354, 184684, 186205, 187036, 188521, 189734, 191564, 195253, 197149, 202475, 202880, 205844, 206922, 210055, 211416, 212266, 215112, 217611, 218240, 219633, 221172, 223315, 225142, 226992, 229948, 231847, 232319, 234276, 235042, 239240, 241617. 17) Pack Number AMS7819A, UDI B098AMS7819A0, Lot Numbers: 173334, 176639, 177152, 180388, 182683, 186406, 190810, 192202, 192848, 194365, 197188, 199488, 202783, 205388, 206750, 211253, 212412, 215250, 216089, 217246, 220359, 223776, 225483, 226654, 229721, 232212, 233317, 233852, 236921, 238278, 242389.
Quantity Affected: 465 units
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.
Distribution
US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-08
Company
Billings, MT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 136 device recalls issued in the same week, part of 341 device-related FDA actions this month.
Windstone Medical Packaging, Inc. has 36 FDA actions in our database, including 36 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Windstone Medical Packaging, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Windstone Medical Packaging, Inc. have FDA actions?
Windstone Medical Packaging, Inc. has 36 FDA actions in our database, including 36 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2799-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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