Recall Z-2799-2026
- Recall number
- Z-2799-2026
- Event number
- 99323
- Firm
- Windstone Medical Packaging, Inc.
- Firm FEI
- 1000125955
- Product code
- LRO
- Status
- Open, Classified
- Initiated
- 2026-06-08
- Posted
- 2026-07-24
- Root cause
- Material/Component Contamination
- 510(k) numbers
- K905459, K920267, K934028, K883250, K871322, K212258, K874760, K892389, K872011, K934688, K882684, K941846, K920292, K932652, K945831, K901856, K931824, K873973, K933137, K925216, K945481, K961683, K953083, K935686, K854292, K971062, K930270, K914037, K935740, K980137
Product#
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.
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.