Browse Device Recalls
2,260 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,260 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 2,260 FDA device recalls in 2021.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 19, 2021 | LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, ... | The device components experienced a manufacturing process error that resulted in surface damage f... | Class II | Smith & Nephew, Inc. |
| May 19, 2021 | FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact L... | Misaligned placement of an axis mark can cause the patient to experience blurred vision | Class II | CooperVision Inc. |
| May 19, 2021 | AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact... | Misaligned placement of an axis mark can cause the patient to experience blurred vision | Class II | CooperVision Inc. |
| May 19, 2021 | ProxiDiagnost N90. radiography and fluoroscopy system | Following a system restart where the Table Height 2 (TH2) is the default setting and then switche... | Class II | Philips Medical Systems DMC GmbH |
| May 19, 2021 | SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Le... | Misaligned placement of an axis mark can cause the patient to experience blurred vision | Class II | CooperVision Inc. |
| May 19, 2021 | DigitalDiagnost 4 High Performance. radiography and fluoroscopy system | Following a system restart where the Table Height 2 (TH2) is the default setting and then switche... | Class II | Philips Medical Systems DMC GmbH |
| May 19, 2021 | GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860 | Reports received of NO measured below desired dose during transition between primary console and ... | Class I | Vero Biotech, LLC |
| May 18, 2021 | Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, ... | The products experienced a 12-hour excursion from the required refrigerated temperature condition... | Class II | Stryker Spine |
| May 18, 2021 | The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723... | ADVIA Chemistry System and Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 18, 2021 | Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, G... | The products experienced a 12-hour excursion from the required refrigerated temperature condition... | Class II | Stryker Spine |
| May 17, 2021 | Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Num... | The recalling firm was notified by the contract sterilizer that the process parameters of the ste... | Class II | ADRIA SRL |
| May 17, 2021 | AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monit... | In some cases the equipment fails to power up and/or key or button unresponsive or not working. | Class II | Mediana Co., Ltd. |
| May 17, 2021 | CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number L... | The device may show unexpected locus specific signals in addition to those at 22q. Users may obse... | Class II | Cytocell Ltd. |
| May 17, 2021 | JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2... | Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 2... | Class I | Smiths Medical ASD Inc. |
| May 17, 2021 | Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749 | The recalling firm was notified by the contract sterilizer that the process parameters of the ste... | Class II | ADRIA SRL |
| May 17, 2021 | Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745 | The recalling firm was notified by the contract sterilizer that the process parameters of the ste... | Class II | ADRIA SRL |
| May 14, 2021 | PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Pr... | One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may... | Class II | Smiths Medical ASD Inc. |
| May 14, 2021 | DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... | Class I | DeRoyal Industries Inc |
| May 14, 2021 | Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO ... | Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through PO... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| May 14, 2021 | DeRoyal Heart Cath Procedure Pack, REF 89-6556.08 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... | Class I | DeRoyal Industries Inc |
| May 14, 2021 | ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Ins... | Display of potential patient movement might be delayed to the user for high dose treatments. | Class II | Brainlab AG |
| May 14, 2021 | DeRoyal Angio Cath Removal Tray, REF 89-9936.02 | DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lid... | Class I | DeRoyal Industries Inc |
| May 13, 2021 | Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic te... | Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 13, 2021 | Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic te... | Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 13, 2021 | Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic t... | Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 12, 2021 | Prime TC-transport chair intended for medical purposes to assist a person in... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Isolibrium Support Surface - support surface assists in the prevention and tr... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | TruRize Clinical Chair - support structure that places human occupants in upr... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four buil... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Surgistool-intended to support a healthcare professional during surgical proc... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, C... | Labeling does not include guidance for proper water-quality maintenance and device inspection fo... | Class II | CardioQuip, LLC |
| May 12, 2021 | IsoGel Air - support surface assists in the prevention and treatment of all p... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE ... | Labeling does not include guidance for proper water-quality maintenance and device inspection fo... | Class II | CardioQuip, LLC |
| May 12, 2021 | Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, L... | Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vasc... | Class II | W L Gore & Associates, Inc. |
| May 12, 2021 | Symmetry Plus Treatment Recliner - general hospital use as a convenient seati... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | ComfortGel - assists in the prevention and treatment of all pressure injury s... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Stretcher Chair-for use in all acute care hospitals and medical outpatient se... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | CUB Pediatric Crib- intended to provide a pediatric patient support surface f... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. ... | Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains ... | Class II | Encore Medical, LP |
| May 12, 2021 | Transport Stretcher 747 - a non-powered, wheeled device designed to support p... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz.... | Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains ... | Class II | Encore Medical, LP |
| May 12, 2021 | S3 MedSurg Bed - intended to support and transport patients within the Med/Su... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: ... | Labeling does not include guidance for proper water-quality maintenance and device inspection fo... | Class II | CardioQuip, LLC |
| May 12, 2021 | InTouch 2131-intended to support a human patient in an acute care setting, M... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, L... | Vascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vasc... | Class II | W L Gore & Associates, Inc. |
| May 12, 2021 | Michael Graves with Stryker Highback Chair-intended for pediatric and adult p... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | S3 MedSurg Bed - intended to support and transport patients within the Med/Su... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division of Stryker Corporation |
| May 12, 2021 | Proform- support surface is used to assist in the prevention and treatment of... | Medical devices intended for use in a healthcare facility were distributed to residential custom... | Class II | Stryker Medical Division 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.