Z-0133-2026Class II

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

Name: Z-0133-2026 FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION...
Creator: Ferno-Washington Inc
Published: 2025-09-11
License: https://open.fda.gov/license/

Ferno-Washington Inc / initiated 2025-09-11 / Open, Classified / root cause: design

FDA source

Ferno-Washington Inc began a recall of FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES on 2025-09-11. FDA classified it as Class II and gives the reason as "The fastening post hardware could loosen allowing the fastening post to detach from the cot". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0133-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-11
Posted: 2025-10-10
Recalling firm: Ferno-Washington Inc
Product: FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES.
Product code: FPO Stretcher, Wheeled
Reason for recall: The fastening post hardware could loosen allowing the fastening post to detach from the cot
Root cause tag: design
FDA root 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 [email protected] 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 [email protected]
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0133-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0133-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-10

Product code FPO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)