AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206
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.
- Agency
- FDA Device
- Recall date
- Jun 8, 2026
- Status
- Ongoing
- Company
- Windstone Medical Packaging, Inc.
1. What product was recalled?
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Pack Number AMS15517; 3) ENT Facial Pack, Pack Number AMS15863A.
Quantity: 919 units
Code or lot text: 1) Pack Number AMS12206, UDI B098AMS122060, Lot Numbers: 201002, 205119, 206649, 211870, 215233, 217552, 218967, 219166, 222076, 224914, 227000, 228485, 230336, 231348, 232214, 238290, 239795, 241802. 2) Pack Number AMS15517, UDI B098AMS155170, Lot Numbers: 215924, 218494, 235207, 241105. 3) Pack Number AMS15863A, UDI B098AMS15863A0, Lot Numbers: 229370, 235320, 235699, 237597, 239311, 241458.
- LOT
- 1) Pack Number AMS12206
- LOT
- 205119
- LOT
- 206649
- LOT
- 211870
- LOT
- 215233
- LOT
- 217552
- LOT
- 218494
- LOT
- 218967
- LOT
- 219166
- LOT
- 222076
- LOT
- 224914
- LOT
- 227000
- LOT
- 228485
- LOT
- 230336
- LOT
- 231348
- LOT
- 232214
- LOT
- 235207
- LOT
- 235320
- LOT
- 235699
- LOT
- 237597
- LOT
- 238290
- LOT
- 239311
- LOT
- 239795
- LOT
- 241105. 3) Pack Number AMS15863A
- LOT
- 241458.
- LOT
- 241802. 2) Pack Number AMS15517
- LOT
- Lot Numbers: 201002
- LOT
- Lot Numbers: 215924
- LOT
- Lot Numbers: 229370
- LOT
- UDI B098AMS122060
- LOT
- UDI B098AMS155170
- LOT
- UDI B098AMS15863A0
- RECALL-NUMBER
- Z-2800-2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B
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.
Quantity: 465 units
Code or lot text: 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.
- LOT
- 1) Pack Number AMS10411B
- LOT
- 176639
- LOT
- 177152
- LOT
- 179354
- LOT
- 180388
- LOT
- 182683
- LOT
- 184684
- LOT
- 186205
- LOT
- 186406
- LOT
- 187036
- LOT
- 188521
- LOT
- 189734
- LOT
- 190090
- LOT
- 190810
- LOT
- 191564
- LOT
- 192202
- LOT
- 192848
- LOT
- 194365
- LOT
- 195253
- LOT
- 196504
- LOT
- 197149
- LOT
- 197188
- LOT
- 197866
- LOT
- 199463
- LOT
- 199488
- LOT
- 199844
- LOT
- 201971. 7) Pack Number AMS13150A
- LOT
- 202475
- LOT
- 202783
- LOT
- 202880
- LOT
- 204081
- LOT
- 204268
- LOT
- 205388
- LOT
- 205844
- LOT
- 206750
- LOT
- 206922
- LOT
- 209263
- LOT
- 210055
- LOT
- 210230
- LOT
- 211253
- LOT
- 211416
- LOT
- 211511
- LOT
- 212266
- LOT
- 212412
- LOT
- 213173
- LOT
- 215112
- LOT
- 215250
- LOT
- 215672. 8) Pack Number AMS13150B
- LOT
- 216089
- LOT
- 216353
- LOT
- 216809
- LOT
- 217246
- LOT
- 217611
- LOT
- 218240
- LOT
- 218664
- LOT
- 219433
- LOT
- 219463
- LOT
- 219473
- LOT
- 219607
- LOT
- 219633
- LOT
- 219640
- LOT
- 219739. 10) Pack Number AMS14496B
- LOT
- 220359
- LOT
- 221172
- LOT
- 221418
- LOT
- 221841
- LOT
- 222572
- LOT
- 222602
- LOT
- 222714
- LOT
- 223315
- LOT
- 223776
- LOT
- 224583
- LOT
- 224670
- LOT
- 224699
- LOT
- 225142
- LOT
- 225483
- LOT
- 225793
- LOT
- 225796
- LOT
- 225855
- LOT
- 226316
- LOT
- 226621. 13) Pack Number AMS16417
- LOT
- 226654
- LOT
- 226678
- LOT
- 226992
- LOT
- 227336
- LOT
- 227598. 11) Pack Number AMS14496C
- LOT
- 227885
- LOT
- 227963
- LOT
- 228169
- LOT
- 228322
- LOT
- 229357
- LOT
- 229410
- LOT
- 229721
- LOT
- 229948
- LOT
- 229995
- LOT
- 230255. 15) Pack Number AMS16586A
- LOT
- 231180
- LOT
- 231368
- LOT
- 231465
- LOT
- 231847
- LOT
- 232135
- LOT
- 232212
- LOT
- 232319
- LOT
- 232835
- LOT
- 232849
- LOT
- 232908
- LOT
- 233233
- LOT
- 233269
- LOT
- 233317
- LOT
- 233688
- LOT
- 233689
- LOT
- 233852
- LOT
- 234167
- LOT
- 234276
- LOT
- 234875
- LOT
- 235042
- LOT
- 235232
- LOT
- 235439
- LOT
- 235630
- LOT
- 235659
- LOT
- 236009. 2) Pack Number AMS10411C
- LOT
- 236235
- LOT
- 236695
- LOT
- 236921
- LOT
- 236978
- LOT
- 237047
- LOT
- 237310. 12) Pack Number AMS14736
- LOT
- 237621
- LOT
- 237697
- LOT
- 237701
- LOT
- 238278
- LOT
- 238623
- LOT
- 239012. 3) Pack Number AMS11963A
- LOT
- 239240
- LOT
- 239249
- LOT
- 239415. 4) Pack Number AMS12636C
- LOT
- 239909
- LOT
- 241617. 17) Pack Number AMS7819A
- LOT
- 241666. 14) Pack Number AMS16586
- LOT
- 241667. 9) Pack Number AMS14496A
- LOT
- 241824. 6) Pack Number AMS13150
- LOT
- 241987. 16) Pack Number AMS7619A
- LOT
- 242190. 5) Pack Number AMS12731
- LOT
- 242389.
- LOT
- Lot Numbers: 172113
- LOT
- Lot Numbers: 173334
- LOT
- Lot Numbers: 176227
- LOT
- Lot Numbers: 192735
- LOT
- Lot Numbers: 202549
- LOT
- Lot Numbers: 207772
- LOT
- Lot Numbers: 211494
- LOT
- Lot Numbers: 216052
- LOT
- Lot Numbers: 216273
- LOT
- Lot Numbers: 217216
- LOT
- Lot Numbers: 219232
- LOT
- Lot Numbers: 219316
- LOT
- Lot Numbers: 223681
- LOT
- Lot Numbers: 229154
- LOT
- Lot Numbers: 231376
- LOT
- Lot Numbers: 233268
- LOT
- Lot Numbers: 237159
- LOT
- UDI B098AMS10411B0
- LOT
- UDI B098AMS10411C0
- LOT
- UDI B098AMS11963A0
- LOT
- UDI B098AMS12636C0
- LOT
- UDI B098AMS127310
- LOT
- UDI B098AMS131500
- LOT
- UDI B098AMS13150A0
- LOT
- UDI B098AMS13150B0
- LOT
- UDI B098AMS14496A0
- LOT
- UDI B098AMS14496B0
- LOT
- UDI B098AMS14496C0
- LOT
- UDI B098AMS147360
- LOT
- UDI B098AMS164170
- LOT
- UDI B098AMS16586
- LOT
- UDI B098AMS16586A0
- LOT
- UDI B098AMS7619A0
- LOT
- UDI B098AMS7819A0
- RECALL-NUMBER
- Z-2799-2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A
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.
Quantity: 7306 units
Code or lot text: 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.
- LOT
- 1) Pack Number AMS13574A
- LOT
- 179837
- LOT
- 181956
- LOT
- 184890
- LOT
- 191784
- LOT
- 194017
- LOT
- 196708
- LOT
- 197543
- LOT
- 199137
- LOT
- 201956
- LOT
- 210134
- LOT
- 213914
- LOT
- 215434
- LOT
- 216076
- LOT
- 216357
- LOT
- 217352
- LOT
- 218234
- LOT
- 218443
- LOT
- 218696
- LOT
- 219827
- LOT
- 221799
- LOT
- 222999
- LOT
- 223766
- LOT
- 224253
- LOT
- 224568
- LOT
- 225039
- LOT
- 225332
- LOT
- 226168
- LOT
- 226497
- LOT
- 226627
- LOT
- 226657
- LOT
- 227324
- LOT
- 227667
- LOT
- 228151
- LOT
- 228224
- LOT
- 228446
- LOT
- 228678
- LOT
- 229309
- LOT
- 229404
- LOT
- 229717
- LOT
- 230108. 4) Pack Number AMS14991B
- LOT
- 230422
- LOT
- 230472
- LOT
- 230623
- LOT
- 230666
- LOT
- 231694
- LOT
- 233097
- LOT
- 233211
- LOT
- 233399
- LOT
- 233592
- LOT
- 233960
- LOT
- 234577
- LOT
- 234586
- LOT
- 234763
- LOT
- 234907
- LOT
- 235614
- LOT
- 236220
- LOT
- 236351. 3) Pack Number AMS14991A
- LOT
- 236465
- LOT
- 236581
- LOT
- 236666
- LOT
- 236684
- LOT
- 236852
- LOT
- 236897. 2) Pack Number AMS14710B
- LOT
- 237358
- LOT
- 237544
- LOT
- 238089
- LOT
- 238563
- LOT
- 238575
- LOT
- 238613. 6) Pack Number AMS16499
- LOT
- 239092
- LOT
- 239114
- LOT
- 240344
- LOT
- 240373
- LOT
- 240779
- LOT
- 240967. 9) Pack Number AMS17945
- LOT
- 241010
- LOT
- 241332. 12) Pack Number AMS3150G
- LOT
- 241412. 8) Pack Number AMS17336
- LOT
- 241514. 11) Pack Number AMS3150F
- LOT
- 241565. 10) Pack Number AMS17946
- LOT
- 241717. 7) Pack Number AMS16709
- LOT
- 241927.
- LOT
- 242113. 14) Pack Number AMS9771
- LOT
- Lot Numbers: 176784
- LOT
- Lot Numbers: 211888
- LOT
- Lot Numbers: 215450
- LOT
- Lot Numbers: 215711
- LOT
- Lot Numbers: 219872
- LOT
- Lot Numbers: 222621
- LOT
- Lot Numbers: 223361
- LOT
- Lot Numbers: 224717
- LOT
- Lot Numbers: 233346. 5) Pack Number AMS16278
- LOT
- Lot Numbers: 233541
- LOT
- Lot Numbers: 235478
- LOT
- Lot Numbers: 235911
- LOT
- Lot Numbers: 235954
- LOT
- Lot Numbers: 242374. 13) Pack Number AMS5451D
- LOT
- UDI B098AMS13574A0
- LOT
- UDI B098AMS14710B0
- LOT
- UDI B098AMS14991A0
- LOT
- UDI B098AMS14991B0
- LOT
- UDI B098AMS162780
- LOT
- UDI B098AMS164990
- LOT
- UDI B098AMS167090
- LOT
- UDI B098AMS173360
- LOT
- UDI B098AMS179450
- LOT
- UDI B098AMS179460
- LOT
- UDI B098AMS3150F0
- LOT
- UDI B098AMS3150G0
- LOT
- UDI B098AMS5451D0
- LOT
- UDI B098AMS97710
- RECALL-NUMBER
- Z-2802-2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C
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.
Quantity: 927 units
Code or lot text: 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.
- LOT
- 1) Pack Number AMS12195C
- LOT
- 216766
- LOT
- 217573
- LOT
- 217806
- LOT
- 219221
- LOT
- 220779
- LOT
- 222013
- LOT
- 222070
- LOT
- 222520
- LOT
- 222686
- LOT
- 223506
- LOT
- 223714
- LOT
- 224418
- LOT
- 224581
- LOT
- 225092
- LOT
- 225587
- LOT
- 225839
- LOT
- 226568
- LOT
- 226652
- LOT
- 227439
- LOT
- 227717
- LOT
- 227813
- LOT
- 228598
- LOT
- 230393
- LOT
- 230569
- LOT
- 231091
- LOT
- 233313
- LOT
- 233855
- LOT
- 234027
- LOT
- 234138
- LOT
- 234503
- LOT
- 234756
- LOT
- 235331
- LOT
- 235909
- LOT
- 236416
- LOT
- 236502
- LOT
- 236869
- LOT
- 237474. 6) Pack Number AMS6452B
- LOT
- 238000
- LOT
- 238280
- LOT
- 238356. 2) Pack Number AMS12195D
- LOT
- 239036
- LOT
- 240751. 7) Pack Number AMS9427C
- LOT
- 241680. 4) Pack Number AMS16313
- LOT
- 242405.
- LOT
- Lot Numbers: 212195
- LOT
- Lot Numbers: 216097
- LOT
- Lot Numbers: 217757
- LOT
- Lot Numbers: 220948
- LOT
- Lot Numbers: 235956
- LOT
- Lot Numbers: 240974. 3) Pack Number AMS12307
- LOT
- Lot Numbers: 241787. 5) Pack Number AMS17958
- LOT
- UDI B098AMS12195C0
- LOT
- UDI B098AMS12195D0
- LOT
- UDI B098AMS12307
- LOT
- UDI B098AMS163130
- LOT
- UDI B098AMS179580
- LOT
- UDI B098AMS6452B0
- LOT
- UDI B098AMS9427C0
- RECALL-NUMBER
- Z-2801-2026
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
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.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
View source evidence for state distribution
- Arizona: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
- California: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
- Connecticut: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
- Georgia: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
- Illinois: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
- Massachusetts: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
- Maryland: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
- New York: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
- Ohio: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
- Pennsylvania: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
- Tennessee: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
- Texas: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
- Virginia: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
- Washington: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. Recall Index urgency is elevated, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Device source
Recall Index normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.