Ossur Recalls Multiple Medical Devices Including Knee Undersleeves and Walkers
Ossur Americas is recalling various medical devices, including knee undersleeves and walkers, due to a defect described in the source text.
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: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ossur Americas is recalling a wide range of medical devices, including the Knee Undersleeve Gray, Knee Shield / Patella Cup, NecLoc Extrication Collar, Rebound Cartilage, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders, and various Unloader Custom braces. The recall also includes Papoose Infant Spine Immobilizers and Extreme Custom devices.
The source text indicates that these products are being recalled because of a defect, though the specific nature of the defect is not fully detailed in the provided excerpt. The recall involves 456 units of the Knee Undersleeve Gray, which are worn as an accessory for comfort under knee braces. These items were distributed across numerous U.S. states, including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, and WV.
Consumers who have purchased these products should stop using them and contact Ossur Americas for further instructions on how to return or dispose of the items. The recall number for this action is Z-1286-2016.
The recalled product
- Product
- Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces.
- Manufacturer
- Ossur H / F
- Hazard
- Affected units
- 456
Distribution
Part of a larger recall action
This product is one of 14 recalled by Ossur H / F under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
Same manufacturer · Ossur H / F
See all →- HighMiami J Select Collar Recalled Due to Adhesive Failure
FDA (Devices) · 2024-10-09
- HighProsthetic knee recalled due to firmware defect causing device shutdown
FDA (Devices) · 2024-05-22
- HighProsthetic Knee Firmware Defect Risks Unintended Shutdown and Patient Falls
FDA (Devices) · 2024-05-22
- HighProsthetic knee recalled due to firmware issues causing potential device shutdown
FDA (Devices) · 2024-05-22
- HighOssur RHEO Knee XC Prosthetic Components Recall Due to Firmware Issues
FDA (Devices) · 2024-05-22
Same hazard · defect
See all →- ModerateOER-ELITE Endoscope Reprocessor Connecting Tubes Recalled Nationwide
FDA (Devices) · 2026-04-29
- HighMedical convenience kits with syringes recalled due to quality issues
FDA (Devices) · 2024-09-04
- ModerateBVI CustomEyes Procedure Packs Recalled for Sol-M Syringe Issue
FDA (Devices) · 2024-09-04
- HighMedline Medical Procedural Kits Recalled for Defective Plastic Syringes
FDA (Devices) · 2024-09-04
- ModerateBVI CustomEyes Procedure Packs with Sol-M Syringes Recalled
FDA (Devices) · 2024-09-04