Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| May 21, 2019 | Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replaceme... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replace... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of ... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of ... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 21, 2019 | The Alinity ci-series System Control Modules which are configured with Alinit... | All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrate... | Class II | Abbott Gmbh & Co. KG |
| May 21, 2019 | The device is a 25-gauge infusion line that is part of 25-gauge surgical pack... | Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line | Class II | Dutch Ophthalmic USA, Inc. |
| May 21, 2019 | Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replaceme... | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size... | Class II | Medtronic Inc |
| May 17, 2019 | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARR... | Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (... | Class II | Arrow International Inc |
| May 16, 2019 | Cepheid Xpert C. difficile/Epi Control Panel | Product is labeled with expiration date of 2021-10-31, should be 2021-03-31. | Class III | Microbiologics Inc |
| May 16, 2019 | GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm). | Incorrect coil length on the label | Class II | Codman & Shurtleff Inc |
| May 9, 2019 | Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald i... | The diluent tubing used on the instrument appears cloudy or to have a powder/film on the inner an... | Class II | Abbott Laboratories |
| May 3, 2019 | Leica Cryostats, used to produce frozen sample sections for biological, medic... | The current labelling does not include any specific warning about usage of flammable freezing spr... | Class II | Leica Microsystems, Inc. |
| May 3, 2019 | OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERIL... | The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (... | Class II | XTANT MEDICAL INC |
| Apr 26, 2019 | Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D... | There is an error in the chromomap on the package insert. | Class III | Cytocell Ltd. |
| Apr 25, 2019 | Lidar System for Erosion Flume Application Class 1 Laser Product Product ... | Failure to comply event due to incorrect labeling of a class 1 laser product. | Class II | ASTRA, LLC |
| Apr 24, 2019 | ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: Th... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Produ... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Prod... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads fun... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 24, 2019 | Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Pack... | The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensi... | Class II | Boston Scientific Neuromodulation Corporation |
| Apr 18, 2019 | Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestra... | The products are mislabeled. | Class II | K2M, Inc |
| Apr 18, 2019 | Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO,... | A design related issue can contribute to the device exhibiting brittle behavior. This behavior ma... | Class II | Stryker Neurovascular |
| Apr 18, 2019 | Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015)... | The products are mislabeled. | Class II | K2M, Inc |
| Apr 16, 2019 | AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth El... | An Ad-Tech Clinical Specialist, attended a case on April 15, 2019. During the case the surgeon en... | Class II | Ad-Tech Medical Instrument Corporation |
| Apr 11, 2019 | NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage Pure... | Certain lots were mislabeled with incorrect product number. | Class II | NxStage Medical, Inc. |
| Apr 11, 2019 | NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B S... | Certain lots were mislabeled with incorrect product number. | Class II | NxStage Medical, Inc. |
| Apr 2, 2019 | Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)0019070701651... | Orthodontic Bracket is mislabeled | Class II | Ortho Organizers, Inc. |
| Apr 2, 2019 | Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (... | Orthodontic Bracket is mislabeled | Class II | Ortho Organizers, Inc. |
| Apr 1, 2019 | Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical interverteb... | Incorrect part description contained on an additional label placed on the packaging: A 14mm lengt... | Class II | Zimmer Biomet, Inc. |
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.