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 |
|---|---|---|---|---|
| Feb 12, 2021 | NUVASIVE PRECICE UNYTE System (Humerus and Tibia): PRECICE Trauma Nail Sys... | Due to not having the full complement of biological assessments for all potential patients and as... | Class II | Nuvasive Specialized Orthopedics Inc |
| Feb 12, 2021 | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnos... | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Feb 12, 2021 | PRECICE STRYDE - Product Usage: intended for limb lengthening, open and clo... | Due to complaints of adverse events potentially related to biological safety. The complaints inc... | Class II | Nuvasive Specialized Orthopedics Inc |
| Feb 12, 2021 | PRECICE PLATE - Product Usage: intended for limb lengthening, open and clos... | Due to complaints of adverse events potentially related to biological safety. The complaints inc... | Class II | Nuvasive Specialized Orthopedics Inc |
| Feb 12, 2021 | VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products... | VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using ... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Feb 11, 2021 | PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC053... | Distal tip may become separated from the lumen wire in specific lots. | Class I | Cordis Corporation |
| Feb 11, 2021 | Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Ref... | Defect in the mechanical assembly of the needle holder contained in the navigation kit. One of th... | Class II | Imactis |
| Feb 11, 2021 | Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and acces... | The tube holder can separate from the barrier that secures the device to the patients' body. The... | Class II | Hollister Incorporated |
| Feb 11, 2021 | Operating Table System | There is a potential for hydraulic leakage at the inclination function to occur resulting in an u... | Class II | Getinge Group Logistics America, LLC |
| Feb 11, 2021 | JUDKINS PACK | Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) ... | Class II | Cardinal Health 200, LLC |
| Feb 10, 2021 | Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous,... | Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Bas... | Class II | Howmedica Osteonics Corp. |
| Feb 9, 2021 | Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A | Customers were not notified of previous recalls associated with various defibrillator models. | Class II | Philips North America LLC |
| Feb 9, 2021 | Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A | Customers were not notified of previous recalls associated with various defibrillator models. | Class II | Philips North America LLC |
| Feb 9, 2021 | Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). A single ... | Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta... | Class II | Cardinal Health 200, LLC |
| Feb 9, 2021 | Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304 | Customers were not notified of previous recalls associated with various defibrillator models. | Class II | Philips North America LLC |
| Feb 9, 2021 | Magellan 3 mL Syringe with Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x ... | Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta... | Class II | Cardinal Health 200, LLC |
| Feb 9, 2021 | McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen ... | Safety shield not locking into the cannula. If the safety shield activation fails to lock a conta... | Class II | Cardinal Health 200, LLC |
| Feb 9, 2021 | In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot m... | This Field Action is being conducted following identification of manufacturing non-conformity of ... | Class II | In2Bones, SAS |
| Feb 9, 2021 | Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A | Customers were not notified of previous recalls associated with various defibrillator models. | Class II | Philips North America LLC |
| Feb 8, 2021 | Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2 | Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correctio... | Class II | Siemens Healthcare Diagnostics, Inc |
| Feb 8, 2021 | Mizuho CE IPX4, mode MOT-5602BW, 100-240, 50-60Hz, 400VA, REF 18-140-20 conta... | There is a potential that hand control units may cause the tabletop to slide in the opposite dire... | Class II | Mizuho OSI |
| Feb 8, 2021 | The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in... | Use of the kits after incorrect storage could lead to a potential false-negative or invalid resul... | Class II | Meridian Bioscience Inc |
| Feb 8, 2021 | SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult | Non-conformity (holes/punctures or deep creases) in the sterile barrier. | Class II | Sharp Medical Products |
| Feb 7, 2021 | NM/CT 850 Nuclear Medicine / CT Scanners | GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause... | Class II | GE Healthcare, LLC |
| Feb 7, 2021 | NM/CT 870 DR Nuclear Medicine / CT Scanners | GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could caus... | Class II | GE Healthcare, LLC |
| Feb 7, 2021 | NM/CT 860 Nuclear Medicine / CT Scanners | GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could caus... | Class II | GE Healthcare, LLC |
| Feb 5, 2021 | System INFX-8000V | The x-ray irradiation field may shift with respect to image receiving surface displayed on the sc... | Class II | Canon Medical System, USA, INC. |
| Feb 5, 2021 | Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination ... | Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labelin... | Class III | OraSure Technologies, Inc. |
| Feb 5, 2021 | System INFX-8000F | The x-ray irradiation field may shift with respect to image receiving surface displayed on the sc... | Class II | Canon Medical System, USA, INC. |
| Feb 5, 2021 | System INFX-8000C | The x-ray irradiation field may shift with respect to image receiving surface displayed on the sc... | Class II | Canon Medical System, USA, INC. |
| Feb 5, 2021 | DJO EMPOWR KNEE Femoral Sizer | Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show th... | Class II | Encore Medical, LP |
| Feb 4, 2021 | Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reserv... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Card... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Custom Perfusion Pack (CUSTOM PACK HY11B40R1 1/4 RESPIRATO). The Af... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). ... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION... | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients expose... | Class I | Medtronic Perfusion Systems |
| Feb 4, 2021 | Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz... | The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) int... | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 3, 2021 | Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR,... | A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Feb 3, 2021 | Coronavirus antigen detection test system - Product Usage: intended for the q... | Two lots of test strips failed QC testing using blank buffer due to false positives. | Class II | LumiraDx |
| Feb 3, 2021 | Implantable cardioverter defibrillators (ICD) with cardiac resynchronization ... | A small percentage of implanted cardiac devices, from a well-defined subset, may experience a sho... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Feb 3, 2021 | Thread-like wire marker | This recall has been initiated due to the risk of wire splintering after contact with a cautery d... | Class II | Somatex Medical Technologies GMBH |
| Feb 3, 2021 | Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: use... | Siemens Healthcare Diagnostics Inc. has confirmed the potential for erroneous results due to disc... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 2, 2021 | Alcon Custom Ophthalmic Surgical Procedure Packs | Reports have been received concerning mold found on gowns included in custom ophthalmic surgery ... | Class II | Alcon Research, LLC |
| Feb 2, 2021 | IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Softw... | Manufacturing failed to follow process steps resulting in the distribution of potentially defecti... | Class II | Philips North America Llc |
| Feb 1, 2021 | HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutt... | There can be a potential breach of the sterile packaging barrier due to the development of pinhol... | Class II | Bovie Medical 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.