Recall StatusOpen, Classified
Date Initiated2026-06-19
Product Quantity278
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.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.