Recall Z-2760-2026
Ferno-Washington Inc · initiated June 19, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for professional use only. Designed to load, unload, and secure a compatible wheeled stretcher inside a ground-based ambulance. Item no. 0567091
Codes / lots: UDI-DI 00190790006570 Serial Numbers: 25C227687 25C228204 26C232382 26C233091 25C227688 25C228205 26C232383 26C233092 25C227689 26C231797 26C232384 26C233093 25C227690 26C231798 26C232709 26C233094 25C227691 26C231799 26C232710 26C233095 25C227692 26C231800 26C232711 26C233096 25C227693 26C231801 26C232712 26C233097 25C227694 26C232002 26C232713 26C233098 25C227695 26C232004 26C232714 26C233099 25C227696 26C232005 26C232715 26C233100 25C227697 26C232006 26C232716 26C233111 25C227698 26C232007 26C232717 26C233112 25C227699 26C232008 26C232718 26C233113 25C227700 26C232009 26C233032 26C233114 25C227701 26C232010 26C233033 26C233115 25C227702 26C232011 26C233035 26C233116 25C227703 26C232374 26C233036 26C233117 25C227704 26C232375 26C233037 26C233118 25C227707 26C232377 26C233038 26C233119 25C227708 26C232378 26C233039 26C233120 25C227709 26C232379 26C233040 26C233443 25C227710 26C232380 26C233041 26C233444 25C227711 26C232381 26C233090 26C233446 26C233448 26C234080 26C234360 26C234647 26C233449 26C234081 26C234361 26C234648 26C233450 26C234082 26C234362 26C234649 26C233451 26C234083 26C234363 26C234797 26C233452 26C234084 26C234364 26C234798 26C233692 26C234085 26C234566 26C234799…
Reason for recall
Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become lodged during operation and movement of the stretcher along the rail may no longer be possible through either powered or manual operation. May cause delays in transport of patient to healthcare facility.
FDA-determined cause: Process control
Action taken
On June 19. 2026, the firm began notifying customers via Urgent Medical Device Correction letters. Customers were instructed to contact Ferno for assistance if abnormal rail movement, increased resistance during rail extension or retraction, or other unusual rail operation is observed. Ferno will contact all affected customers directly and dispatch trained field service personnel to perform the correction onsite at customer locations. The correction does not require removal of the PF2 Fastening System from service prior to the scheduled repair. The field correction consists of replacement of the affected roller assembly with an updated assembly manufactured in accordance with revised assembly requirements intended to eliminate the potential for interference and subsequent roller deformation.
Details
- Recall number
- Z-2760-2026
- Initiated
- June 19, 2026
- Posted by FDA
- July 17, 2026
- Product code
- FPO – Stretcher, Wheeled
- Quantity
- 278
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, GA, IA, ID, IL, IN, KY, LA, MD, ME, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Poland, Netherlands, Canada, Germany, Norway, United Kingdom, Denmark and New Zealand.
- Recalling firm
- Ferno-Washington Inc, Wilmington, OH