Browse Device Recalls
3,010 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,010 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 3,010 FDA device recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 25, 2019 | Fetal Spiral Electrode, Model No. 9898 031 37631 | During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain... | Class II | Philips North America, LLC |
| Jan 25, 2019 | Obturator (long cone), Part number 25162 Product Usage: The obturator is ... | The weld may break, resulting in the rod separating from the cone of the long and short cone Obtu... | Class II | Medrobotics Corporation |
| Jan 24, 2019 | AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mis... | Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump... | Class II | Maquet Cardiovascular, LLC |
| Jan 22, 2019 | Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Num... | This action has been initiated to address complaint reports received for crimp balloon and inflat... | Class II | Edwards Lifesciences, LLC |
| Jan 22, 2019 | COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002 | There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... | Class II | AtriCure, Inc. |
| Jan 22, 2019 | COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001 | There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... | Class II | AtriCure, Inc. |
| Jan 22, 2019 | COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S | There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... | Class II | AtriCure, Inc. |
| Jan 22, 2019 | COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI | There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... | Class II | AtriCure, Inc. |
| Jan 22, 2019 | VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro ... | Imprecision in the affected lot may produce negatively or positively biased patient sample and qu... | Class II | Ortho-Clinical Diagnostics |
| Jan 21, 2019 | Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage... | The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instr... | Class II | Stryker GmbH |
| Jan 19, 2019 | Revolution CT scanners Product Usage: The system is intended for head, wh... | Additional low dose radiation exposure. | Class II | GE Healthcare, LLC |
| Jan 18, 2019 | SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product U... | Cosmetic Kit was packaged with a mislabel medical product. | Class II | Bellus Medical |
| Jan 17, 2019 | Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber ... | A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 17, 2019 | Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD):... | A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 17, 2019 | On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X... | On-X Valve was mislabeled with the incorrect serial number. | Class II | CryoLife, Inc. |
| Jan 17, 2019 | Medtronic implantable pulse generator: Versa, Dual chamber rate responsive p... | A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 17, 2019 | MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices | The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indica... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 17, 2019 | Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD):... | A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 17, 2019 | MEDTRONIC CARELINK 2090 programmer | There is an error in how the programmer calculates and displays the remaining longevity value dur... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 17, 2019 | vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1... | A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 17, 2019 | Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamb... | A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 17, 2019 | Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expirati... | The product may not meet sterility requirements. Product labeled as sterile, however all units do... | Class II | DJO, LLC |
| Jan 17, 2019 | Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer | There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 po... | Class II | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 17, 2019 | Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): ... | A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 ... | Class I | Medtronic Inc., Cardiac Rhythm and Heart Failur... |
| Jan 16, 2019 | Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as... | Some lots of test strips do not fit tightly into the optical block, and may fall out during analy... | Class II | Polymer Technology Systems, Inc. |
| Jan 16, 2019 | daVinci Harmonic ACE Curved Shears | During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Ha... | Class II | Intuitive Surgical, Inc. |
| Jan 16, 2019 | Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a... | Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen l... | Class II | Edwards Lifesciences, LLC |
| Jan 16, 2019 | CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 | Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal... | Class III | Carolina Liquid Chemistries |
| Jan 16, 2019 | Lipid Panel test strips (as a component of smart bundles), REF 2729, also pri... | Some lots of test strips do not fit tightly into the optical block, and may fall out during analy... | Class II | Polymer Technology Systems, Inc. |
| Jan 16, 2019 | CHOL+HDL+GLU test strips, REF 2412 | Some lots of test strips do not fit tightly into the optical block, and may fall out during analy... | Class II | Polymer Technology Systems, Inc. |
| Jan 16, 2019 | CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321 | Class III | Carolina Liquid Chemistries | |
| Jan 15, 2019 | Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for... | A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID con... | Class II | Westmed, Inc. |
| Jan 15, 2019 | Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is ... | FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the ... | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Jan 15, 2019 | Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible I... | A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID con... | Class II | Westmed, Inc. |
| Jan 15, 2019 | Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The P... | Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified a... | Class II | Miami Device Solutions, LLC. |
| Jan 15, 2019 | Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for u... | A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID con... | Class II | Westmed, Inc. |
| Jan 14, 2019 | SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product U... | In these units, the brake is usually released by gripping the drive handle and applied by letting... | Class II | Shimadzu Medical Systems Usa Com |
| Jan 14, 2019 | RUSCH CARE Premium Drain bag, 2000mlm REF 390000 urine collection device | The device labels are not UDI compliant. The missing UDI compliance information on the labelling ... | Class III | Teleflex Medical |
| Jan 14, 2019 | 3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper C... | 3M has recently received reports involving the 3MTM Surgical Clipper by Remington¿, Model 9602, o... | Class II | 3M Company - Health Care Business |
| Jan 14, 2019 | RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device | The device labels are not UDI compliant. The missing UDI compliance information on the labelling ... | Class III | Teleflex Medical |
| 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 14, 2019 | TRINIAS for diagnostic imaging and interventional procedures in cardiac angio... | Two issues: Event 1: Normal operation of the device is to power up the device in the morning, ... | Class II | Shimadzu Medical Systems Usa Com |
| Jan 14, 2019 | Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices ar... | Devices may generate excessive heat during use. | Class II | Arthrex, Inc. |
| Jan 14, 2019 | BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is ... | Normal operation of the device is to power up the device in the morning, register the first patie... | Class II | Shimadzu Medical Systems Usa Com |
| Jan 11, 2019 | Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID... | This notice has been initiated due to potential for compromised test card Top Seal Integrity whic... | Class II | Organon Teknika Inc |
| Jan 11, 2019 | aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Su... | There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel b... | Class II | AAP Implantate Ag |
| Jan 11, 2019 | Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (l... | Shelf life of the product may be reduced due to degradation of the assay. | Class III | Lin-Zhi International Inc |
| Jan 10, 2019 | Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Cathe... | The product lidstock contains a labelling error. The lidstock states the incorrect priming volume... | Class II | Arrow International Inc |
| Jan 10, 2019 | 21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is ... | Some of the installed valve-inserts have a diameter smaller than the specification. | Class II | Ottobock Orthopedic Industrie |
| Jan 10, 2019 | Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Cathe... | The product lidstock contains a labelling error. The lidstock states the incorrect priming volume... | Class II | Arrow International 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.