MEDICAL DEVICE RECALLMODERATE

AMS Medical Convenience Kits

Windstone Medical recalls AMS medical convenience kits due to potential endotoxin variability in included sponges.

What to do

If you have an affected AMS medical convenience kit, stop using it immediately and contact Windstone Medical Packaging, Inc. for instructions on return and replacement.

Recalled

2026-06-08

Listed

2026-07-24

Updated

2026-09-07

Recall No.

Z-2800-2026

Agency

FDA

Firm

Windstone Medical Packaging, Inc.

Recall ID

99323

Status

ONGOING

Why it was recalled

Windstone Medical Packaging, Inc. is recalling AMS Aligned Medical Solutions medical convenience kits, including ENT, Rhinoplasty, Spine, Lumbar Lami, Septoplasty, Laryngoscopy, Nasal and Sinus, and Major Packs, due to potential for unexpected variability of endotoxin levels in Medicom Ritmed Neurological Sponges included in the kits. The affected kits come in a range of sizes and pack formats. The full list of affected part numbers is available on the FDA recall detail page.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled

Product	Lot code	Recall #	UDI-DI
as	201002, 205119, 206649, 211870, 215233, 217552, 218967, 219166, 222076, 224914, 227000, 228485, 230336, 231348, 232214, 238290, 239795, 241802, AMS15517, 215924, 218494, 235207, 241105, AMS15863A, 229370, 235320, 235699, 237597, 239311, 241458	Z-2800-2026	–
as	217757, 222686, 224418, 225587, 227439, 228598, 230569, 234138, 235331, 236869, 238356, AMS12195D, 240974, AMS12307, 220948, 234027, 234756, 235909, 238000, 239036, 241680, AMS16313, 241787, AMS17958, 235956, 237474, AMS6452B, 212195, 217806, 220779, 222520, 223506, 224581, 225839, 226652, 227717, 233855, 234503, 236416, 240751 (+17 more, see the official notice)	Z-2801-2026	–
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 AMS144	–	Z-2799-2026	–
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;	–	Z-2802-2026	–
as	219316, 221418, 225796, 227963, 229410, 231465, 232835, 234875, 236009, AMS10411C, 237159, 239012, AMS11963A, 219232, 221841, 231180, 233233, 235232, 237047, 239415, AMS12636C, 216052, 216353, 219607, 222572, 227336, 228169, 232135, 232908, 236235, 242190, AMS12731, 211494, 219640, 224583, 225855, 226678, 228322, 231368, 241824 (+136 more, see the official notice)	–	B098AMS10411B0, B098AMS10411C0, B098AMS11963A0, B098AMS12636C0, B098AMS127310, B098AMS131500, B098AMS13150A0, B098AMS13150B0, B098AMS14496A0, B098AMS14496B0, B098AMS14496C0, B098AMS147360, B098AMS164170, B098AMS16586, B098AMS16586A0, B098AMS7619A0, B098AMS7819A0
as	235911, 236897, AMS14710B, 224717, 230666, 213914, 236351, AMS14991A, 215450, 230108, AMS14991B, 233346, AMS16278, 219872, 222999, 226497, 229309, 236465, 237544, 238613, AMS16499, 215711, 218234, 224253, 226168, 226627, 227667, 228446, 230422, 233097, 233399, 233960, 234577, 234907, 236220, 236852, 237358, 238563, 239114, 240373 (+70 more, see the official notice)	–	B098AMS13574A0, B098AMS14710B0, B098AMS14991A0, B098AMS14991B0, B098AMS162780, B098AMS164990, B098AMS167090, B098AMS173360, B098AMS179450, B098AMS179460, B098AMS3150F0, B098AMS3150G0, B098AMS5451D0, B098AMS97710

Where it was sold

Distributed nationwide.

Timeline

2026-06-08Firm initiated recall
2026-07-24Publicly announced
2026-07-26Listed on Recall Canary
2026-09-07Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-07 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification