ClearanceBrief
Recall Z-0133-2026 ยท FPO Stretcher, Wheeled

Ferno-Washington Inc

FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.

DateOct 10, 2025 (initiated Sep 11, 2025)
StatusOpen, Classified
ReasonThe fastening post hardware could loosen allowing the fastening post to detach from the cot
Root causeDevice Design
ActionFERNO issued an URGENT PRODUCT CORRECTION notice to its consignees on 09/11/2025 via USPS certified mail. The notice explained the issue, potential risk to user, and requested the consignee identify the affected unit, inspect it using the following criteria: Visual Inspection " Look for gaps between the fastener head and the surface. " Check for missing fasteners. " Look for shiny wear marks, rust streaks, or metal shavings around the fastener these can indicate movement. " Inspect for vibration marks (circular or elongated wear around bolt holes). Physical/Manual Check " Hand-check: Use yo
Quantity138 units
DistributionUS Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, IS, IL, KY, LA, MN, MO, NC, ND, NE, NM, NY, OH, OK, PA, TN, TX, UT, VA, WI, WV.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.