FDA recall, , Moderate risk
AMS Aligned Medical Solutions Surgical Procedure Packs
Medical convenience kits contain neurological sponges with potentially variable endotoxin levels.
Summary by Recall Canary from the FDA notice
What happened
Windstone Medical Packaging, Inc., of Billings, Montana, recalled AMS Aligned Medical Solutions medical convenience kits because they contain Medicom Neurological Sponges Non-Sterile Models 55992C to 55998C that may have unexpected variability of endotoxin levels.
The recall, initiated June 8, 2026, was added to the FDA's Enforcement Report on July 24, 2026, and covered kits distributed in Arizona, California, Connecticut, Georgia, Illinois, Massachusetts, Maryland, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, and Washington.
2 photos
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Match the list below, then check the codes the FDA notice also names.
Incomplete list: 356 of 373 lot codes shown.
AMS Aligned Medical Solutions medical convenience kits
- Lot code
- 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
- 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
- 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
- AMS13150
- 172113
- 190090
- 196504
- 197866
- 199463
- 199844
- 201971
- AMS13150A
- 202549
- 204081
- 209263
- 210230
- 211511
- 213173
- 215672
- AMS13150B
- 216273
- 216809
- 218664
- 219473
- 222602
- 224670
- 225793
- 227885
- 229995
- 232849
- 234167
- 235630
- 236695
- 237697
- 239909
- 241667
- AMS14496A
- 207772
- 219739
- AMS14496B
- 223681
- 224699
- 226316
- 227598
- AMS14496C
- 231376
- 237310
- AMS14736
- 192735
- 204268
- 222714
- 226621
- AMS16417
- 217216
- 219433
- 219463
- 229357
- 235439
- 237701
- 241666
- AMS16586
- 229154
- 230255
- AMS16586A
- 233268
- 233269
- 233688
- 233689
- 235659
- 236978
- 237621
- 238623
- 239249
- 241987
- AMS7619A
- 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
- AMS7819A
- 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
- 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
- 241010
- 241717
- AMS16709
- 223361
- 225039
- 236666
- 240344
- 241412
- AMS17336
- 233541
- 240967
- AMS17945
- 235478
- 240779
- 241565
- AMS17946
- 235954
- 239092
- 241514
- AMS3150F
- 211888
- 216076
- 216357
- 218443
- 219827
- 221799
- 223766
- 227324
- 228151
- 229404
- 229717
- 230623
- 231694
- 233211
- 234586
- 234763
- 236581
- 241332
- AMS3150G
- 242374
- AMS5451D
- 222621
- 224568
- 238089
- 238575
- 242113
- AMS9771
- 176784
- 179837
- 181956
- 184890
- 191784
- 194017
- 196708
- 197543
- 199137
- 201956
- 210134
- 215434
- 217352
- 218696
- 225332
- 226657
- 228224
- 228678
- 230472
- 233592
- 235614
- 236684
- 241927
From the FDA notice
1) ENT Pack, Part Number AMS10411B;
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Arizona, California, Connecticut, Georgia, Illinois, Massachusetts, Maryland, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington.
- Company
- Windstone Medical Packaging, Inc.Billings, Montana
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99323
- Recall numbers
- Z-2799-2026 to Z-2802-2026
All recalls from Windstone Medical Packaging, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
