Class 2 Device Recall FERNO POWER X2 Powered Ambulance Cot

• Date Initiated by Firm: September 11, 2025
• Date Posted: October 10, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0133-2026
• Recall Event ID: 97606
• Product Classification: Stretcher, wheeled - Product Code FPO
• Product: FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.
• Code Information: UDI-DI 00190790003210, Serial Numbers: 25G036127,25G036128, 25G036151, 25G036152, 25G036153, 25G036154, 25G036155, 25G036156, 25G036157, 25G036158, 25G036267, 25G036268, 25G036269, 25G036612, 25G036613, 25G036614, 25G036652, 25G036653, 25G036654, 25G036801, 25G036802, 25G036803, 25G036804, 25G036827, 25G036828, 25G036829, 25G036830, 25G036833, 25G036834, 25G036835, 25G036836, 25G036837, 25G036921, 25G036922, 25G036923, 25G036924, 25G036925, 25G036926, 25G036927, 25G036928, 25G036929, 25G036930, 25G036951, 25G036952, 25G036953, 25G036954, 25G036958, 25G036959, 25G036960, 25G036961, 25G036962, 25G036963, 25G036964, 25G037067, 25G037068, 25G037069, 25G037070, 25G037071, 25G037072, 25G037093, 25G037094, 25G037095, 25G037096, 25G037097, 25G037098, 25G037100, 25G037159, 25G037160, 25G037161, 25G037162, 25G037163, 25G037165, 25G037215, 25G037216, 25G037217, 25G037218, 25G037219, 25G037222, 25G037223, 25G037224, 25G037225, 25G037226, 25G037227, 25G037228, 25G037229, 25G037271, 25G037272, 25G037273, 25G037274, 25G037275, 25G037276, 25G037277, 25G037278, 25G037279, 25G037280, 25G037281, 25G037282, 25G037283, 25G037284, 25G037285, 25G037286, 25G037287, 25G037288, 25G037289, 25G037298, 25G037299, 25G037300, 25G037301, 25G037302, 25G037303, 25G037304, 25G037305, 25G037336, 25G037337, 25G037338, 25G037339, 25G037340, 25G037341, 25G037342, 25G037344, 25G037345, 25G037346, 25G037347, 25G037466, 25G037467, 25G037468, 25G037469, 25G037470, 25G037471, 25G037472, 25G037473, 25G037474, 25G037526, 25G037595, 25G037596, 25G037597, 25G037598, 25G037599, 25G037600, 25G037601, 25G037602, 25G037623, 25G037665, 25G037691, 25G037692, 25G037703, 25G037704, 25G037707, 25G037766, 25G037767, 25G037768, 25G037769, 25G037770, 25G037772, 25G037774, 25G037780, 25G037781, 25G037782, 25G037786, 25G038074, 25G038075, 25G038076, 25G038077, 25G038079, 25G038082, 25G038083, 25G038084, 25G038088, 25G038089, 25G038090, 25G038536, 25G038537, 25G038538, 25G038539, 25G038540, 25G038564, 25G038575, 25G038576, 25G038577, 25G038578, 25G038615, 25G038616, 25G038617, 25G038618, 25G038619, 25G038625, 25G038626, 25G038627, 25G038628, 25G038698, 25G038754, 25G038765, 25G038766, 25G038767, 25G038768, 25G038769
• Recalling Firm/ Manufacturer: Ferno-Washington Inc; 70 Weil Way; Wilmington OH 45177-9371
• For Additional Information Contact: DOROTHY RAMSEY; 1-937-2832885
• Manufacturer Reason for Recall: The fastening post hardware could loosen allowing the fastening post to detach from the cot
• FDA Determined Cause: Device Design
• Action: FERNO 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 your fingers or a small wrench to see if the fastener turns easily when it should not. " Shake or tap test: Lightly tap the fastener or surrounding component with a non-marring tool; rattling or movement suggests looseness. Functional Signs " Listen for unusual rattling or vibration during operation. " Check for misalignment of connected parts (hinges, brackets, covers, panels). " Watch for loosened thread-locking compounds if broken, the fastener may have shifted. IF A COT IS FOUND TO HAVE LOOSE OR MISSING HARDWARE, YOU MUST IMMEDIATELY REMOVE IT FROM SERVICE UNTIL THE REPAIR IS COMPLETE. Upon receipt of this Notice, please call Ferno Technical Support at 866-987-3776 or email tscoordinator@ferno.com to (1) acknowledge receipt of this notice, (2) advise if any of your Power X2 serial numbers are affected, (3) advise if and how many of your affected serial numbers contain loose and/or missing hardware on the fastening post, and (4) make arrangements for trained service technicians to correct your ambulance cot. In the event you sold or donated the identified product, please forward this notice to your consignee and advise Ferno of the consignee information so we may follow up. Malfunctions or quality problems experienced with the use of your POWER X2 Powered Ambulance Cot may be reported to Ferno at 866-987-3776 or tscoordinator@ferno.com
• Quantity in Commerce: 138 units
• Distribution: US 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.