Browse Device Recalls
806 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 806 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 806 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 1, 2019 | NexGenTrabecular Metal Tibial Half Block Augment, Left Lateral/Right Medial, ... | Potentially comingled, resulting in the product in the box potentially not matching the product o... | Class II | Zimmer Trabecular Metal Technology, Inc. |
| Jan 28, 2019 | Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: ... | The product may not have met sterility requirements . Use of a non-sterile device on a patient m... | Class II | Applied Medical Resources Corp |
| Jan 14, 2019 | BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX S... | False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically... | Class II | Becton Dickinson & Co. |
| Jan 9, 2019 | Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Lab... | An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. | Class II | ConvaTec, Inc |
| Dec 26, 2018 | Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) G... | On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplifica... | Class III | Luminex Corporation |
| Dec 21, 2018 | SmartPath to dStream for 1.5T, Model Number 781260. Nuclear Magnetic Resona... | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... | Class II | Philips Medical Systems Nederlands |
| Dec 21, 2018 | Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper A... | The product was potentially being packaged without a taper adapter. | Class II | Zimmer Biomet, Inc. |
| Dec 21, 2018 | SmartPath to dStream for XR and 3.0T, Model Number 781270. Nuclear Magnetic... | There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the ... | Class II | Philips Medical Systems Nederlands |
| Dec 12, 2018 | GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with... | Unintentional shifting of the tip insulation of the firm's electrosurgical probes. | Class II | Applied Medical Resources Corp |
| Nov 27, 2018 | ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... | Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... | Class II | ICU Medical, Inc. |
| Nov 27, 2018 | ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... | Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... | Class II | ICU Medical, Inc. |
| Nov 27, 2018 | ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Samp... | Reports of pressure tubing separation between the sampling port and the high pressure tubing on c... | Class II | ICU Medical, Inc. |
| Nov 19, 2018 | Medex High Pressure Stopcock used to control the direction of IV fluid flow. ... | Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that m... | Class II | Smiths Medical ASD Inc. |
| Oct 17, 2018 | Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should ... | There is a potential deficiency of the TEXAS Bronchoscope Tube product. The non-functionally rel... | Class II | Richard Wolf GmbH |
| Oct 16, 2018 | MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PUL... | Devices were distributed despite the Helium-fine leak test results not being within the cochlear ... | Class II | MED-EL Elektromedizinische Gereate, Gmbh |
| Oct 16, 2018 | MED EL Cochlear Implant System, SONATATIi100, sold under the following implan... | Devices were distributed despite the Helium-fine leak test results not being within the cochlear ... | Class II | MED-EL Elektromedizinische Gereate, Gmbh |
| Oct 16, 2018 | MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the follo... | Devices were distributed despite the Helium-fine leak test results not being within the cochlear ... | Class II | MED-EL Elektromedizinische Gereate, Gmbh |
| Oct 10, 2018 | L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic f... | Potential presence of leaks from the cassettes, which may be present due to an incomplete seal of... | Class II | Baxter Healthcare Corporation |
| Oct 9, 2018 | BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2... | This recall has been initiated due to a software defect found in the Guide System software when u... | Class I | Synaptive Medical Inc |
| Oct 5, 2018 | GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066... | The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. ... | Class I | GE Healthcare, LLC |
| Sep 21, 2018 | BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos... | The device may not function at the lower end (<15 deg. C) of the labeled operating temperatures. ... | Class III | Becton Dickinson & Co. |
| Sep 14, 2018 | VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pac... | Potential to lead to a false negative results. | Class II | Luminex Corporation |
| Sep 7, 2018 | Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administr... | Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer... | Class II | Bayer Medical Care, Inc. |
| Aug 1, 2018 | Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - ... | There is a potential for increased imprecision, out of range quality controls and prolonged sampl... | Class II | Instrumentation Laboratory Co. |
| Jul 30, 2018 | Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 P... | The item is labeled as an 8.3mm, but it is actually a 12 mm. | Class II | Zimmer Biomet, Inc. |
| Jul 3, 2018 | AbViser AutoValve IAP (intra- abdominal pressure) Monitoring Device, Patient ... | Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the ... | Class II | ConvaTec, Inc |
| Jul 2, 2018 | Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the foll... | From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried o... | Class II | Radiometer America Inc |
| Jun 19, 2018 | NICO Shepherd' s Hook - Greenberg, sterile. An accessory to NICO s BrainPath ... | Mislabeled hook pouch included a transport/storage label rather than the product label containin... | Class II | Nico Corp. |
| May 25, 2018 | Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (... | This voluntary recall is being conducted due to the curved tip introducer needle which is include... | Class II | Medtronic Neuromodulation |
| May 25, 2018 | Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a... | This voluntary recall is being conducted due to the curved tip introducer needle which is include... | Class II | Medtronic Neuromodulation |
| May 22, 2018 | Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat.... | The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein ... | Class II | Randox Laboratories Ltd. |
| May 22, 2018 | Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat.... | The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein ... | Class II | Randox Laboratories Ltd. |
| May 22, 2018 | Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat.... | The recalling firm has confirmed that Free Kappa light chains in Liquid Assayed Specific Protein ... | Class II | Randox Laboratories Ltd. |
| May 8, 2018 | Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identific... | Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nu... | Class II | Luminex Corporation |
| Apr 30, 2018 | PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a pro... | A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused lea... | Class II | Polymedco, Inc.,/Polymedco Cancer Diagnostic Pr... |
| Apr 30, 2018 | PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST... | A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused lea... | Class II | Polymedco, Inc.,/Polymedco Cancer Diagnostic Pr... |
| Apr 25, 2018 | Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTIO... | A recent FDA inspection of the firm revealed significant Current Good Manufacturing Practices (cG... | Class II | Conseal International, Inc. |
| Apr 20, 2018 | Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris P... | Complaints where users were unable to prime the administration set. | Class II | CareFusion 303, Inc. |
| Apr 19, 2018 | MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, S... | The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be ... | Class II | MicroAire Surgical Instruments, LLC |
| Apr 2, 2018 | PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The P... | The connector of the power supply was capable of fitting other components provided with the syste... | Class II | Bio-Rad Laboratories Inc |
| Mar 26, 2018 | 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability S... | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... | Class II | Ethicon Endo-Surgery Inc |
| Mar 26, 2018 | 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability S... | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... | Class II | Ethicon Endo-Surgery Inc |
| Mar 26, 2018 | AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis... | Drill bit tips without new BargerGard tip protector may puncture through sterile packaging. | Class II | Tornier, Inc |
| Mar 26, 2018 | 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability S... | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... | Class II | Ethicon Endo-Surgery Inc |
| Mar 26, 2018 | 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability S... | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... | Class II | Ethicon Endo-Surgery Inc |
| Mar 26, 2018 | 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability S... | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... | Class II | Ethicon Endo-Surgery Inc |
| Mar 23, 2018 | Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
| Mar 23, 2018 | The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VI... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
| Mar 23, 2018 | The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the V... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
| Mar 16, 2018 | Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: In... | Potential risk for helium gas inside the MR examination room during a magnet quench | Class II | Philips Electronics North America 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.