Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion S... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 29, 2019 | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets ... | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore inf... | Class II | ICU Medical Inc |
| Jul 22, 2019 | Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems. | Reversed expiration and manufacturing date on the label | Class II | GETINGE US SALES LLC |
| Jul 19, 2019 | AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: ... | Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore.. | Class II | Boston Scientific Corporation |
| Jul 19, 2019 | NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Onl... | The top label for dental implant may incorrectly indicate the implant length. Specifically, the l... | Class II | Nobel Biocare Usa Llc |
| Jul 17, 2019 | U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urod... | Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage... | Class II | LABORIE MEDICAL TECHNOLOGIES, CORP |
| Jul 16, 2019 | xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral ... | The Assay may give a false negative result when detecting and subtyping Influenza A (H3) and dete... | Class II | Luminex Molecular Diagnostics |
| Jul 11, 2019 | Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1 | Potential for prior thumbnails to not display in reverse chronological order and images may not s... | Class II | Merge Healthcare, Inc. |
| Jul 11, 2019 | Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1 | Potential for prior thumbnails to not display in reverse chronological order and images may not s... | Class II | Merge Healthcare, Inc. |
| Jul 8, 2019 | GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled ... | Potential for certain GRIPPER Needles to contain an occluded or blocked needle. | Class II | Smiths Medical ASD Inc. |
| Jul 8, 2019 | GRIPPER Needles sold individually. Labeled as the following item description... | Potential for certain GRIPPER Needles to contain an occluded or blocked needle. | Class II | Smiths Medical ASD Inc. |
| Jul 3, 2019 | PediaLift Access Device, Device Identifier: B751PDLFT0 | The firm was unsuccessful in obtaining a satisfactory Certificate of Conformance from the origi... | Class II | PediaLift LLC |
| Jul 3, 2019 | CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Elect... | Possible mis-labeling of the device with incorrect serial number labels which may result in a pat... | Class II | Capso Vision, Inc. |
| Jun 27, 2019 | AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .01... | The affected product is properly labelled with an expiration date of March 31, 2022; but the RFID... | Class II | Angiodynamics, Inc. |
| Jun 24, 2019 | IQon Spectral CT Model # 728332, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | Vereos PET/CT Model # 882446, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | Ingenuity Core Model # 728321, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | iCT SP Model # 728311, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | Ingenuity CT, Model # 728326, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | iCT, Model # 728306, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | Brilliance 64 Model # 728231, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | Ingenuity Core128 Model # 728323, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 18, 2019 | Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 uni... | Mislabeled - The product's labeling contains an incorrect size for the catheter included in the k... | Class II | Epimed International, Inc. |
| Jun 18, 2019 | LSB Style Anchor Bolt. Labeled with the following parts: 13mm anodized ... | On June 12, 2019 Ad-Tech was made aware that on three different occasions between March 1, 2019 a... | Class II | Ad-Tech Medical Instrument Corporation |
| Jun 18, 2019 | Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 uni... | Mislabeled - The product's labeling contains an incorrect size for the catheter included in the... | Class II | Epimed International, Inc. |
| Jun 17, 2019 | Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For card... | If battery maintenance is not performed appropriately, the battery may provide less than the mini... | Class I | Datascope Corp. |
| Jun 17, 2019 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For card... | Battery short-run times and unanticipated stoppage may be due to user not performing battery main... | Class I | Datascope Corp. |
| Jun 17, 2019 | CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiova... | If battery maintenance is not performed appropriately, the battery may provide less than the mini... | Class I | Datascope Corp. |
| Jun 17, 2019 | CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiova... | If battery maintenance is not performed appropriately, the battery may provide less than the mini... | Class I | Datascope Corp. |
| Jun 10, 2019 | Luer Lock Set - Catalog # MPC-125, for IV administration sets. | Mislabeling - Some unit of sale packages (bags of 100 sets of MPC-125) were found to be incorrect... | Class II | Molded Products Inc |
| Jun 7, 2019 | Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Re... | The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the a... | Class III | Polymer Technology Systems, Inc. |
| Jun 7, 2019 | PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: ... | The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the a... | Class III | Polymer Technology Systems, Inc. |
| Jun 4, 2019 | Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Ite... | The products do not have sufficient data to support the labeled shelf life of 10 years. | Class II | Zimmer Biomet, Inc. |
| Jun 4, 2019 | Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usa... | The products do not have sufficient data to support the labeled shelf life of 10 years. | Class II | Zimmer Biomet, Inc. |
| Jun 3, 2019 | SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure ... | Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 ... | Class II | Suntech Medical, Inc. |
| May 30, 2019 | Clearview Total Uterine Manipulator (model UM750), The device is labeled in ... | An incorrect component used during manufacturing. The uterine manipulator tip support does not ha... | Class II | Clinical Innovations, LLC |
| May 30, 2019 | Anti-fog solution packaged in a Tyvek peel pouch and it is placed into variou... | The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties. | Class II | Medline Industries, Inc. |
| May 28, 2019 | Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Pa... | The device was distributed with the outer carton labeled with the manufacture date and the expiry... | Class II | Datascope 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.