Browse Device Recalls
28 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 28 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 28 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 29, 2022 | OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power... | Battery may dislodge from the Power Knee | Class II | Ossur Americas |
| May 30, 2022 | OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for chil... | Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring i... | Class II | Ossur Americas |
| Nov 9, 2021 | Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJ... | Instructions for use were updated to include additional information to facilitate the selection a... | Class II | Ossur Americas |
| Jun 1, 2021 | OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross imm... | Due to insufficient column strength of the racks for all load conditions, racks associated with h... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KOD... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skul... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERIL... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERIL... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| Jun 21, 2018 | Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pi... | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm M... | Class II | Ossur Americas |
| 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 |
| Oct 15, 2012 | The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee d... | OSSUR is recalling the Symbionic Leg because it is not recognizing the low battery warning signal... | Class II | Ossur Americas, Inc. |
| Feb 12, 2012 | The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee d... | OSSUR initiated this recall of the Symbionic Leg because it may have a possible defect in a small... | Class II | Ossur Americas, Inc. |
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.