Browse Device Recalls
3,013 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,013 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 3,013 FDA device recalls in 2018.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 12, 2018 | MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a m... | The temperature of the incubation lids of the MINC Bench top Incubators may become too high or to... | Class II | Cook Inc. |
| Jan 12, 2018 | BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile... | One of the cases of product might not have been sterilized. | Class II | Medline Industries, Inc. |
| Jan 12, 2018 | Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee syst... | Firm became aware that the specific product/lot combinations referenced above may contain the inc... | Class II | Howmedica Osteonics Corp. |
| Jan 11, 2018 | GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 Th... | CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (... | Class II | GE Medical Systems Information Technologies, Inc. |
| Jan 11, 2018 | Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO... | Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color ba... | Class II | TriMed Inc. |
| Jan 11, 2018 | ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, ... | Sterility failure found in one of the units in the lot. | Class II | Ellex iScience, Inc. |
| Jan 11, 2018 | VITROS Immunodiagnostic Products TSH Reagent Pack | VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signa... | Class III | Clinical Diagnostic Systems |
| Jan 11, 2018 | IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Comput... | 23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues inc... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 10, 2018 | PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Si... | Three (3) lots were distributed with the incorrect expiry date on the label. The lots were label... | Class II | Ethicon, Inc. |
| Jan 10, 2018 | Syngo.via software is intended to be used for viewing, manipulation, communic... | When the archiving configuration is changed, data received/created after the upgrade may be flagg... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 10, 2018 | PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Si... | Three (3) lots were distributed with the incorrect expiry date on the label. The lots were label... | Class II | Ethicon, Inc. |
| Jan 10, 2018 | PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Si... | Three (3) lots were distributed with the incorrect expiry date on the label. The lots were label... | Class II | Ethicon, Inc. |
| Jan 9, 2018 | RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Us... | Product is labeled with "CE", but is not yet approved in the European Union. | Class III | Riverpoint Medical, LLC |
| Jan 9, 2018 | LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the q... | The incorrect placement of AA batteries into certain LeadCare Plus Blood Lead Analyzer may cause ... | Class II | Magellan Diagnostics, Inc. |
| Jan 9, 2018 | LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P,... | The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause th... | Class II | Magellan Diagnostics, Inc. |
| Jan 8, 2018 | Syngo.via. Medical Device Software. Picture archiving and communications sys... | A software functionality in the report sections Findings Information and Summary of Measured F... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 8, 2018 | Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletal... | Nine lots of 8.5 mm Polyaxial Pedicle Screws are at risk of breakage. | Class II | Innovasis, Inc |
| Jan 5, 2018 | Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module ... | When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pau... | Class II | ICU Medical, Inc. |
| Jan 5, 2018 | AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 77283... | Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the ... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 5, 2018 | Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic ... | Contains a gel-like contaminant that may affect product performance. | Class III | Diamedix Corporation |
| Jan 5, 2018 | Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use... | Contains a gel-like contaminant that may affect product performance. | Class III | Diamedix Corporation |
| Jan 4, 2018 | Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended... | The low and high controls for the product are returning results above the assigned values. | Class II | The Binding Site Group, Ltd. |
| Jan 4, 2018 | BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*... | Increase of events affecting performance regarding pump clogging and displacement of the color-co... | Class II | bioMerieux, Inc. |
| Jan 4, 2018 | Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 ... | The power supply unit may be damaged and may fail to start up when the power plug is inserted int... | Class II | Toshiba American Medical Systems Inc |
| Jan 4, 2018 | BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) ... | Increase of events affecting performance regarding pump clogging and displacement of the color-co... | Class II | bioMerieux, Inc. |
| Jan 4, 2018 | Allura Xper systems with Certeray X-ray Generator located in regions with hig... | There is an increase in the failure rate of certain Anode Drive Units (ADU5) used in these produc... | Class II | Philips Electronics North America Corporation |
| Jan 3, 2018 | Percuvance(R) Percutaneous Shaft 29cm, PCVSH3 The Percutaneous Surgical Sy... | There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and p... | Class II | Teleflex Medical |
| Jan 3, 2018 | Trabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UD... | Two lots of hip implants are mislabeled. | Class II | Zimmer Biomet, Inc. |
| Jan 3, 2018 | Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244... | Software issues including: Software errors that may result in Extended Field of View check messa... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 3, 2018 | Percuvance(R) Percutaneous Shaft 36cm, PCVSHL3 The Percutaneous Surgical S... | There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and p... | Class II | Teleflex Medical |
| Jan 3, 2018 | MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; PA023E Probe 7.5/10 | The ultrasound system used in certain settings may result in overheating of the ultrasound probe ... | Class II | ESAOTE S.P.A. |
| Jan 3, 2018 | Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 ... | Software issues including: Software errors that may result in Extended Field of View check messa... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 3, 2018 | MyLab Ultrasound System; Models 6100, 6150, 6200, 6250; Probes: BL433, C 18, ... | The ultrasound system used in certain settings may result in overheating of the ultrasound probe ... | Class II | ESAOTE S.P.A. |
| Jan 3, 2018 | Intellivue iX Information Center Software - All PIIC iX Surveillance stations... | Once a surveillance station is restarted on January 1, 2018 or later, the station will be unable ... | Class II | Philips Electronics North America Corporation |
| Jan 3, 2018 | HEMASHIELD Knitted Double Velour Cardiovascular Fabric | A probable mislabeling of the product: a different-sized product is referenced on the product pac... | Class II | GETINGE US SALES LLC |
| Jan 3, 2018 | Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal c... | Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lac... | Class II | Medtronic Perfusion Systems |
| Jan 2, 2018 | ADVIA Centaur¿ Folate (FOL) | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ /IMMULITE ¿ 1000 TG | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi TG | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE 2000/IMMULITE ¿ 2000 XPi OM-MA (CA125) | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge | The concentrations for biotin listed in the non-interfering substances section of the instruction... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable D... | An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems. | Class II | Stryker Sustainability Solutions |
| Jan 2, 2018 | IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12 | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | ADVIA Centaur¿ Cyclosporine | The concentrations for biotin listed in the non-interfering substances section of the instruction... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid | Concentrations for the level of biotin that does not interfere is not currently listed in the ins... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable D... | An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems. | Class II | Stryker Sustainability Solutions |
| Jan 2, 2018 | Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge | The concentrations for biotin listed in the non-interfering substances section of the instruction... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 2, 2018 | Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas... | The previous version of method sheets for the Acetaminophen assay on the COBAS INTEGRA 400 plus/... | Class II | Roche Diagnostics 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.