Recall Z-1924-2026 ยท FYD Apparatus, Exhaust, Surgical
SurgiSmoke Solutions
Flamingo Funnel Small, Model Number SQ20012-01
| Date | Apr 22, 2026 (initiated Mar 16, 2026) |
| Status | Open, Classified |
| Reason | Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. |
| Root cause | Packaging change control |
| Action | An URGENT: MEDICAL DEVICE RECALL notification letter was sent to customers beginning 3/16/26. Actions to be taken by the Customer/End User: 1. Immediately discontinue use of this product. Note: The lots listed in this notice are the only lots impacted. All subsequently built product contains a correct, gamma compatible drape. 2. Dispose of impacted product according to local and national waste disposal procedures. Note: ALL PRODUCT MUST BE ACCOUNTED FOR ON THE MEDICAL DEVICE RECALL RETURN RESPONSE ACKNOWLEDGEMENT AND RECEIPT FORM. 3. Acknowledge receipt of this notice. Complete an |
| Quantity | 2505 units total |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT. The country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K894038 | PLUME-AWAY SMOKE EVACUATION SYSTEM Laser Technologies Group, Inc., Sep 28, 1989 |