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 |
|---|---|---|---|---|
| Mar 28, 2018 | Ingenuity TF PET/CT 882442 | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 28, 2018 | Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to ach... | The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead ... | Class II | Ace Surgical Supply Co., Inc. |
| Mar 28, 2018 | Ingenuity Core128 728323 | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 28, 2018 | Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattac... | Specific lots of the device were overexposed during EtO sterilization. This may lead to revision ... | Class II | Zimmer Biomet, Inc. |
| Mar 28, 2018 | Philips Ingenuity Core 728321 | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 28, 2018 | Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a)... | products may be missing a one-way valve on the fluid patient port. | Class II | Cardinal Health 200, LLC |
| Mar 28, 2018 | Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS2040... | Software anomaly resulting in the loss of patient settings and stored patient data. | Class II | Draegar Medical Systems, Inc. |
| Mar 28, 2018 | Brilliance Big Bore Radiology 728244 | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 27, 2018 | Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile | Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demo... | Class II | Trilliant Surgical Ltd. |
| Mar 27, 2018 | Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644... | These one-way valves may disconnect at the joint between the two components that make up the devi... | Class II | Teleflex Medical Europe Ltd |
| Mar 27, 2018 | ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on A... | Urea Nitrogen reagent kit demonstrated an increased incidence of Calibration Failures. Results ca... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 27, 2018 | Syngo.Via VB20A model 1049610 | Functionality in the report sections "Findings Information" and "Summary of Measured Findings" no... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 27, 2018 | Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile | Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demo... | Class II | Trilliant Surgical Ltd. |
| Mar 26, 2018 | Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm lengt... | Potential failure of sterile packaging seal. | Class II | Zimmer Biomet, Inc. |
| Mar 26, 2018 | Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Leng... | Potential failure of sterile packaging seal. | Class II | Zimmer Biomet, Inc. |
| Mar 26, 2018 | M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 c... | Potential failure of sterile packaging seal. | Class II | Zimmer Biomet, Inc. |
| Mar 26, 2018 | BECKMAN COULTER MicroScan MICroSTREP Plus Panel, MicroScan Mueller-Hinton Bro... | Beckman Coulter has received customer complaints of lowered minimum inhibitory concentration (MIC... | Class II | Beckman Coulter Inc. |
| Mar 26, 2018 | ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length... | Potential failure of sterile packaging seal. | Class II | Zimmer Biomet, Inc. |
| Mar 26, 2018 | Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm lengt... | Potential failure of sterile packaging seal. | Class II | Zimmer Biomet, Inc. |
| Mar 26, 2018 | MultiDim Eleva 708032 As a multifunctional universal imaging application... | The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... | Class II | Philips Medical Systems Nederlands |
| 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 | Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional univers... | The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... | Class II | Philips Medical Systems Nederlands |
| Mar 26, 2018 | MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional unive... | The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... | Class II | Philips Medical Systems Nederlands |
| Mar 26, 2018 | Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47... | Potential failure of sterile packaging seal. | Class II | Zimmer Biomet, Inc. |
| Mar 26, 2018 | ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length... | Potential failure of sterile packaging seal. | Class II | Zimmer Biomet, 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 | Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Leng... | Potential failure of sterile packaging seal. | Class II | Zimmer Biomet, Inc. |
| Mar 26, 2018 | Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm ... | Potential failure of sterile packaging seal. | Class II | Zimmer Biomet, Inc. |
| Mar 26, 2018 | ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, ... | Potential failure of sterile packaging seal. | Class II | Zimmer Biomet, 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 | MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional unive... | The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... | Class II | Philips Medical Systems Nederlands |
| Mar 26, 2018 | MultiDiagnost Eleva 708036 As a multifunctional universal imaging applicat... | The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... | Class II | Philips Medical Systems Nederlands |
| Mar 26, 2018 | Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-225... | Potential failure of sterile packaging seal. | Class II | Zimmer Biomet, 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 | 708033 URODiagnost As a multifunctional universal imaging application syst... | The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... | Class II | Philips Medical Systems Nederlands |
| Mar 26, 2018 | M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter... | Potential failure of sterile packaging seal. | Class II | Zimmer Biomet, Inc. |
| Mar 26, 2018 | Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As... | The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the... | Class II | Philips Medical Systems Nederlands |
| Mar 23, 2018 | Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number ... | A change regarding the shelf life of a raw material was implemented without an appropriate submis... | Class II | Straumann Manufacturing, 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 | Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article N... | A change regarding the shelf life of a raw material was implemented without an appropriate submis... | Class II | Straumann Manufacturing, Inc. |
| Mar 23, 2018 | The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to ... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
| Mar 23, 2018 | Oxidase Reagent (ref: 55635): This test is used to detect the production of t... | 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 Neisseria-Haemophilus identification card (NH) is intended for us... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
| Mar 23, 2018 | Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Si... | Slot screw had an overall length of 15mm, but per the specification, the screw should have an ove... | Class II | Medtronic Sofamor Danek USA Inc |
| Mar 23, 2018 | Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Numbe... | A change regarding the shelf life of a raw material was implemented without an appropriate submis... | Class II | Straumann Manufacturing, Inc. |
| Mar 23, 2018 | The VITEK 2 Gram-Positive identification card (GP) is intended for use with t... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
| Mar 23, 2018 | VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS ... | A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable... | Class II | BioMerieux SA |
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.