| | Class 2 Device Recall Power F2 Powered Fastening System |  |
| Date Initiated by Firm | June 19, 2026 |
| Date Posted | July 17, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2760-2026 |
| Recall Event ID |
99291 |
| Product Classification |
Stretcher, wheeled - Product Code FPO
|
| 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 |
| Code Information |
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
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26C234361
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26C234649
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26C234078
26C234358
26C234645
26C235036
26C234079
26C234359
26C234646
26C235037
26C235038
26C235140
26C235437
26C235699
26C235039
26C235141
26C235438
26C235700
26C235040
26C235142
26C235439
26C235701
26C235041
26C235143
26C235440
26C235702
26C235042
26C235144
26C235441
26C235704
26C235043
26C235145
26C235442
26C235705
26C235044
26C235146
26C235443
26C236027
26C235045
26C235147
26C235444
26C236028
26C235046
26C235148
26C235445
26C236029
26C235047
26C235149
26C235446
26C236030
26C235048
26C235150
26C235447
26C236031
26C235049
26C235151
26C235686
26C236032
26C235050
26C235152
26C235687
26C236035
26C235051
26C235153
26C235688
26C236036
26C235052
26C235428
26C235689
26C236038
26C235053
26C235429
26C235691
26C236039
26C235054
26C235430
26C235692
26C236042
26C235055
26C235431
26C235693
26C236111
26C235134
26C235432
26C235694
26C236252
26C235135
26C235433
26C235695
26C236253
26C235136
26C235434
26C235696
26C235137
26C235435
26C235697
26C235138
26C235436
26C235698 |
| FEI Number |
1523574
|
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 | 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 2 | Process control |
| 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. |
| Quantity in Commerce | 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. |
| 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.
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