Browse Device Recalls
184 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 184 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 184 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 26, 2015 | 3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Tro... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Dou... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 25, 2015 | Universal Charger Product Usage: The Stryker Universal Battery Charg... | The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as desi... | Class III | Stryker Instruments Div. of Stryker Corporation |
| Jan 7, 2015 | System 6 Aseptic Housing. The Stryker System 6 Aseptic Housings provide a ... | Stryker is recalling System 6 Aseptic Housing, due to a failed Continuous Bond Line Test from a h... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Dec 22, 2014 | Flyte Togas are components of the Stryker Flyte System and are intended to be... | A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled... | Class III | Stryker Instruments Div. of Stryker Corporation |
| Oct 8, 2014 | Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The Sma... | The SmartLife Aseptic Housings are being recalled in that the top section of the housing may sepa... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Oct 8, 2014 | Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The Sma... | The SmartLife Aseptic Housings are being recalled in that the top section of the housing may sepa... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Jun 24, 2014 | Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Med... | The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Lindemann Drill Short, 1.6mm Sterile Product Usage: The devices are inte... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices are int... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 5.0mm Egg Bur Sterile Product Usage: The devices are intended to... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 5.0mm Barrel Bur Sterile | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 3.0mm x 3.8mm Neuro Drill Soft Touch Sterile Product Usage: The de... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 5.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The de... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 6.0mm Round Fluted Bur Sterile Product Usage: The devices are int... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 3.0mm Round Fluted Bur Soft Touch Sterile Product Usage: The dev... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 5.5mm Round Fluted Bur Aggressive Sterile Product Usage: The dev... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 0.5mm Round Fluted Bur Sterile Product Usage: The devices are int... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 6.0mm Acorn Bur Sterile Product Usage: The devices are intended ... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 5.0mm Barrel Bur Sterile Product Usage: The devices are intended... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product Usage: ... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The de... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The de... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 4.5mm Round Fluted Bur Aggressive Sterile Product Usage: The dev... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile Product Usage: The ... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices are ... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 6.0mm Round Fluted Bur Aggressive Sterile Product Usage: The dev... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The de... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The ... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are i... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 5.5mm Round Fluted Bur Soft Touch Sterile Product Usage: The dev... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 6.0mm Egg Bur Sterile Product Usage: The devices are intended to... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are int... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The dev... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are int... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The dev... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The d... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The devices... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 22, 2014 | Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended ... | There may be missing notches, partial notches or no notches at all in some Cutting Accessories th... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 13, 2014 | The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-co... | The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may ha... | Class II | Stryker Instruments Div. of Stryker Corporation |
| May 13, 2014 | The NAV3i Platform Power Box supplies the electrical components with power (e... | The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may ha... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2014 | Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an ele... | During packaging verification testing, a failure occurred due to cuts in the packaging potentiall... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 18, 2014 | 2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is co... | Stryker Instruments is voluntarily recalling the single use 2.5MM Aggressive Blade because the li... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Dec 30, 2013 | Neptune 2 Rover Ultra Waste Management System | The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Dec 30, 2013 | Neptune 2 Rover Ultra Waste Management System. | The purpose of this correction is to upgrade the Neptune 2 Waste Management Systems in the field ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Dec 6, 2013 | Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4... | The Color Cuff¿ Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorr... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 4, 2013 | Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single u... | Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Nov 1, 2013 | Acetabular Pressurizer; single use and six units per box. The Acetabular P... | On March 14, 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer ... | Class II | Stryker Instruments Div. of Stryker Corporation |
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.