SPRYSTEP VECTOR Ankle-Foot Orthosis Recalled for Structural Failure Risk
Townsend Design is recalling the SPRYSTEP VECTOR custom ankle-foot orthosis due to potential air pockets between material layers that could cause complete structural failure. Users should stop using the device and contact the manufacturer.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall addresses a structural defect in a medical device that provides mobility support. While no injuries or illnesses have been reported and the failure is potential rather than actual, complete structural breakage of a weight-bearing orthosis poses a significant risk of harm to users.
Plain-English summary
Townsend Design is recalling the SPRYSTEP VECTOR custom dynamic ankle-foot orthosis (AFO), a medical device designed to provide ankle and foot support during walking and mobility. The recall affects 898 units with reference numbers 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, and 17V2037.
The U.S. Food and Drug Administration issued this Class II recall due to potential air pockets between the layers of material used in the orthosis. These air pockets could lead to complete structural breakage of the device. The affected orthoses were distributed across the United States, Puerto Rico, and internationally to Canada, New Zealand, Japan, Australia, the Netherlands, and the United Kingdom.
Users of the recalled SPRYSTEP VECTOR orthosis should discontinue use immediately and contact Townsend Design for instructions on replacement or repair. No injuries or illnesses related to this issue have been reported to date.
The recalled product
- Product
- SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
- Manufacturer
- Townsend Design
- Category
- Medical Device — Orthotic Device
- Hazard
- structural-failure
- material-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- REF:17V1035/UDI: (01)04035459414517 /Order #s: 875828 872283 871945 877520
- REF: 17V2035/UDI: (01)04035459414500/Order #s: 877598 873877 879077 872285
- REF: 17V1037/UDI:(01)04035459414555/Order #s: 881380
- 878083
- REF: 17V2037/UDI:(01)04035459414548/Order #s: 881380
Distribution
Distributed in 47 states:
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- SC
- SD
- TN
- TX
- UT
- VA
- VT
- WA
- WI
- WV
- WY
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