Browse Device Recalls
2,055 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,055 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 2,055 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 5, 2016 | Oxford Partial Knee System Right Medial Tibial Trial Tray Size F Product Usa... | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... | Class II | Biomet U.K., Ltd. |
| Jan 5, 2016 | Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Product Usa... | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... | Class II | Biomet U.K., Ltd. |
| Jan 5, 2016 | Oxford Partial Knee System Left Medial Tibial Trial Tray Size E Product Usag... | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee in... | Class II | Biomet U.K., Ltd. |
| Jan 4, 2016 | Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. ... | Otto Bock HealthCare GmbH is recalling Modular Polycentric EBS Knee Joint that were serviced betw... | Class II | Otto Bock Healthcare GmbH |
| Dec 28, 2015 | EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is int... | All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may ... | Class II | Phadia Ab |
| Dec 15, 2015 | MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Inte... | Due to Operator Console software anomaly, a change in treatment completion status of the last pat... | Class II | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA... |
| Dec 11, 2015 | MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube ... | The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size. | Class II | Benlan, Inc. |
| Dec 10, 2015 | IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2 | When the electric lift table is connected to the mains power, in a very rare occasion, the table ... | Class II | Iba Dosimetry Gmbh |
| Dec 4, 2015 | Synaptive Medical BrightMatter Navigator System (Guide System). Part number S... | Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicat... | Class II | Synaptive Medical, Inc. |
| Nov 19, 2015 | Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW ... | Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically fa... | Class I | Biomerieux |
| Nov 19, 2015 | Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest¿ is a quantita... | Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically fa... | Class I | Biomerieux |
| Nov 19, 2015 | Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitati... | Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically fa... | Class I | Biomerieux |
| Nov 19, 2015 | Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantita... | Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically fa... | Class I | Biomerieux |
| Nov 19, 2015 | MOVES System Lithium Polymer Batteries The MOVES System is a portable comp... | Batteries found unresponsive after storage, not recognized by main device, and are perpetually en... | Class I | Thornhill Research Inc |
| Nov 19, 2015 | MOVES System, an emergency ventilator with suction, oxygen concentrator and m... | Batteries found unresponsive after storage, not recognized by main device, and are perpetually en... | Class I | Thornhill Research Inc |
| Nov 18, 2015 | Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingred... | Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because ... | Class II | Rainbow Specialty & Health Products |
| Nov 18, 2015 | IBS - Osteosynthesis screws for bone fixation Model S25 ST014. | One batch of osteosynthesis screws were manufactured with the incorrect Torx imprint on the screw... | Class II | In2Bones, SAS |
| Nov 18, 2015 | Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingred... | Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because ... | Class II | Rainbow Specialty & Health Products |
| Nov 17, 2015 | Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne ... | Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Pie... | Class II | Lumenis Ltd |
| Nov 11, 2015 | Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926.... | During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Q... | Class II | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) |
| Nov 5, 2015 | RT Elements are applications for radiation treatment planning for use in ster... | Large objects with fine resolution are potentially displayed cropped when imported into Brainlab ... | Class II | Brainlab AG |
| Nov 5, 2015 | RT Elements are applications for radiation treatment planning for use in ster... | Large objects with fine resolution are potentially displayed cropped when imported into Adaptive ... | Class II | Brainlab AG |
| Nov 2, 2015 | ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 580... | There is a risk ECG electrodes of specific lots fail to transmit signals. There is a risk that th... | Class II | Leonhard Lang Medizintechnik GmbH |
| Oct 23, 2015 | iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart... | A software issue can make the foot move into dorsiflexion, unnoticed by the user, who could fall.... | Class II | Otto Bock Healthcare GmbH |
| Oct 22, 2015 | CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans | Monitor may shut down unintentionally without restarting. | Class II | Innokas Medical Oy |
| Oct 20, 2015 | SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of th... | SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the f... | Class II | Pega Medical Inc. |
| Oct 15, 2015 | DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA... | Complaint investigation concluded that although product quality requirements stated in the instr... | Class II | Euro Diagnostica AB |
| Oct 7, 2015 | Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortme... | A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty c... | Class II | Ivoclar A. G. |
| Sep 23, 2015 | Signature Patient-Specific Surgical Guides; patient specific instruments used... | Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because ... | Class II | Materialise N.V. |
| Sep 22, 2015 | Eon 300 system includes the following product reference numbers and names: ... | ELITech clinical Systems reagents based on Trinder reaction used on the Eon 300 instrument system... | Class II | ELITech Clinical Systems SAS |
| Sep 22, 2015 | Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia mea... | Results for ammonia are below the linear range of the assay for samples that have been collected ... | Class II | Sentinel CH SpA |
| Sep 22, 2015 | Envoy 500 system includes the following product reference numbers and names: ... | ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument syst... | Class II | ELITech Clinical Systems SAS |
| Sep 22, 2015 | Eon 100 system included the following product reference numbers and names: ... | ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system... | Class II | ELITech Clinical Systems SAS |
| Sep 22, 2015 | ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems ... | ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM sy... | Class II | ELITech Clinical Systems SAS |
| Sep 21, 2015 | Digital Lightbox, BrainLAB system, image processing, radiological Product ... | Potentially incorrectly displayed objects when actively deselecting a fused reference dataset. | Class II | Brainlab AG |
| Sep 21, 2015 | TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indica... | One mislabeled dose of TheraSphere¿ Y-90 Glass Microspheres, which was shipped to Hong Kong (tota... | Class II | Biocompatibles U.K., Ltd. |
| Sep 3, 2015 | Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Na... | In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged oute... | Class II | Zimmer Gmbh |
| Aug 31, 2015 | MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tou... | Once tested, it is required that the tourniquet be returned to its Ready position then placed in ... | Class II | Pyng Medical Corporation |
| Aug 27, 2015 | Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 U... | Possible loosening of the dental tool, which may lead to potential swallowing of the tool. | Class II | Bien Air Dental SA |
| Aug 24, 2015 | Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal sc... | It would be possible for an abnormal analytical test result value from an affected newborn to be ... | Class II | Perkin Elmer Life Sciences Inc |
| Aug 18, 2015 | Actifuse ABX/Actifuse MIS System A bone void filler intended only for ort... | Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS Sys... | Class II | Apatech Limited |
| Aug 18, 2015 | Disposable Reflective Marker Spheres The Disposable Reflective Marker Sphe... | Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS... | Class II | Brainlab AG |
| Aug 14, 2015 | SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR ... | The dimensions of the mating features of the recalled products are out of specification causing t... | Class II | Limacorporate S.p.A |
| Aug 14, 2015 | SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoul... | The dimensions of the mating features of the recalled products are out of specification causing t... | Class II | Limacorporate S.p.A |
| Aug 12, 2015 | Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufactur... | Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to is... | Class II | Otto Bock Healthcare Product |
| Aug 5, 2015 | ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to... | ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructe... | Class II | Brainlab AG |
| Jul 16, 2015 | Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic ... | Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joi... | Class II | Otto Bock Healthcare GmbH |
| Jul 12, 2015 | Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower ... | The recalling firm has received reports of a malfunction of the Relax wall mounted shower seat wh... | Class II | Etac Supply Center Ab |
| Jul 7, 2015 | RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 6905920... | EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particu... | Class II | Eizo Corporation |
| Jul 7, 2015 | RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, ... | EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particu... | Class II | Eizo 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.