Browse Device Recalls

29 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 29 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 29 FDA device recalls.

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Date	Product	Reason	Class	Firm
Aug 20, 2024	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: ...	Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar ...	Class II	Ossur H / F
Mar 25, 2024	RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic co...	Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a...	Class II	Ossur H / F
Mar 25, 2024	RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic...	Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a...	Class II	Ossur H / F
Mar 25, 2024	RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic...	Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a...	Class II	Ossur H / F
Mar 25, 2024	RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic co...	Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a...	Class II	Ossur H / F
Dec 26, 2023	Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002	Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to ...	Class II	Ossur H / F
May 12, 2023	Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; I...	A mechanical lock used to connect and release a locking liner into a prosthetic socket have an at...	Class II	Ossur H / F
Mar 14, 2016	Ossur Lil Angel Vest P2 Lambswool. Pediatric sized vest is a support structu...	There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.	Class II	Ossur H / F
Mar 14, 2016	Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structu...	There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.	Class II	Ossur H / F
Mar 14, 2016	Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structur...	There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.	Class II	Ossur H / F
Mar 14, 2016	Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure...	There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.	Class II	Ossur H / F
Mar 14, 2016	Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure u...	There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.	Class II	Ossur H / F
Mar 14, 2016	Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure u...	There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.	Class II	Ossur H / F
Feb 24, 2016	Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an ac...	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio...	Class II	Ossur H / F
Feb 24, 2016	Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used ...	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio...	Class II	Ossur H / F
Feb 24, 2016	Unloader Custom Product Usage: Unloader Custom is an external knee braces...	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio...	Class II	Ossur H / F
Feb 24, 2016	NecLoc Extrication Collar Product Usage: Necloc collars are applied to pa...	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio...	Class II	Ossur H / F
Feb 24, 2016	Miami J Collar Product Usage: Miami J collars are applied to patients aff...	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio...	Class II	Ossur H / F
Feb 24, 2016	Extreme Custom Product Usage: Extreme Custom is an external knee braces t...	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio...	Class II	Ossur H / F
Feb 24, 2016	Unloader XT Product Usage: Unloader XT Extreme is an external knee braces...	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio...	Class II	Ossur H / F
Feb 24, 2016	Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio...	Class II	Ossur H / F
Feb 24, 2016	Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an acc...	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio...	Class II	Ossur H / F
Feb 24, 2016	Rebound Cartilage Product Usage: Rebound Cartilage is an external knee br...	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio...	Class II	Ossur H / F
Feb 24, 2016	Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an ex...	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio...	Class II	Ossur H / F
Feb 24, 2016	Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose P...	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio...	Class II	Ossur H / F
Feb 24, 2016	Unloader Custom Lite Product Usage: Unloader Custom Lite is an external ...	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio...	Class II	Ossur H / F
Feb 24, 2016	Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for g...	Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extricatio...	Class II	Ossur H / F
Mar 4, 2015	LP Rotate Foot System prosthetic device for fitting lower extremity amputati...	The threads of the outer tube of the shock module of LP Rotate are too short, resulting in insecu...	Class II	Ossur H / F
Feb 26, 2015	The Rheo Knee bionic prosthetic is to be used exclusively for fittings of low...	The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal a...	Class II	Ossur H / F

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.