FDAClass II · Medical device · Recall Z-2801-2026 · Recalled August 5, 2026

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.

Agency report date: August 5, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as
Company / brand: Windstone Medical Packaging
Lot / serial / date codes: 1) Pack Number AMS12195C, UDI B098AMS12195C0, Lot Numbers: 217757, 222686, 224418, 225587, 227439, 228598, 230569, 234138, 235331, 236869, 238356. 2) Pack Number AMS12195D, UDI B098AMS12195D0, Lot Numbers: 240974. 3) Pack Number AMS12307, UDI B098AMS12307, Lot Numbers: 220948, 234027, 234756, 235909, 238000, 239036, 241680. 4) Pack Number AMS16313, UDI B098AMS163130, Lot Numbers: 241787. 5) Pack Number AMS17958, UDI B098AMS179580, Lot Numbers: 235956, 237474. 6) Pack Number AMS6452B, UDI B098AMS6452B0, Lot Numbers: 212195, 217806, 220779, 222520, 223506, 224581, 225839, 226652, 227717, 233855, 234503, 236416, 240751. 7) Pack Number AMS9427C, UDI B098AMS9427C0, Lot Numbers: 216097, 216766, 217573, 219221, 222013, 222070, 223714, 225092, 226568, 227813, 230393, 231091, 233313, 236502, 238280, 242405.
Distribution: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.

Agency product description and boundaries

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C; 2) Neuro Pack, Pack Number AMS12195D; 3) Neuro Pack, Pack Number AMS12307; 4) Neuro Spine Pack, Pack Number AMS16313; 5) Lami Kukkar Pack, Pack Number AMS17958; 6) Neuro Pack, Pack Number AMS6452B; 7) Neuro Lami Pack, Pack Number AMS9427C.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2801-2026
Brand: Windstone Medical Packaging
Classification: Class II
Units affected: 927 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as

Companies & origin

Recalling firm location: Billings, MT, United States
Firm address: 1602 4th Ave N, N/A, 59101-1521

Identifying details (verbatim from the notice)

Product codes / lots: 1) Pack Number AMS12195C, UDI B098AMS12195C0, Lot Numbers: 217757, 222686, 224418, 225587, 227439, 228598, 230569, 234138, 235331, 236869, 238356. 2) Pack Number AMS12195D, UDI B098AMS12195D0, Lot Numbers: 240974. 3) Pack Number AMS12307, UDI B098AMS12307, Lot Numbers: 220948, 234027, 234756, 235909, 238000, 239036, 241680. 4) Pack Number AMS16313, UDI B098AMS163130, Lot Numbers: 241787. 5) Pack Number AMS17958, UDI B098AMS179580, Lot Numbers: 235956, 237474. 6) Pack Number AMS6452B, UDI B098AMS6452B0, Lot Numbers: 212195, 217806, 220779, 222520, 223506, 224581, 225839, 226652, 227717, 233855, 234503, 236416, 240751. 7) Pack Number AMS9427C, UDI B098AMS9427C0, Lot Numbers: 216097, 216766, 217573, 219221, 222013, 222070, 223714, 225092, 226568, 227813, 230393, 231091, 233313, 236502, 238280, 242405.
Distribution: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
Firm notified the public via: E-Mail
FDA event ID: 99323
Recall initiated: June 8, 2026
FDA classified: July 24, 2026
FDA report date: August 5, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.

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