Recall Z-2983-2026 ยท FLE Sterilizer, Steam
Fort Defiance Industries, LLC
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
| Date | Aug 18, 2026 (initiated Jul 8, 2026) |
| Status | Open, Classified |
| Reason | The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path. |
| Root cause | Component design/selection |
| Action | Between the dates of July 8, 2026 - July 16, 2026 Fort Defiance Industries (FDI) issued a Urgent Medical Device Recall to affected consignees vi Email. FDI ask consignees to take the following actions: 1. Devices can continue in operation until the fix is implemented. 2. In the interim, users should avoid touching the WRS power connector during operation as a precaution. 3. Please contact FDI and order the upgrade kit complete with instructions to perform this Field Correction. 4. After receiving the kit, please review the instructions and determine if you are competent to perform the upda |
| Distribution | Worldwide - US Nationwide distribution in the states of MD, VA, NJ, TN and the countries of Canada, Lithuania, Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141009 | FORT DEFIANCE AUTOMATED STEAM STERILIZER Fort Defiance Industries, Inc., Dec 16, 2014 |