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 |
|---|---|---|---|---|
| Jul 11, 2018 | VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage:... | The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interfere... | Class III | Ortho-Clinical Diagnostics |
| Jul 11, 2018 | POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mas... | Complaints were received on the product, such as the re-breather bag would not fill/inflate or th... | Class II | POM Medical LLC |
| Jul 10, 2018 | djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S... | The retaining ring on the neck trials has a potential to fail interoperatively. | Class II | Encore Medical, LP |
| Jul 10, 2018 | HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only ... | The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of... | Class II | Arrow International Inc |
| Jul 10, 2018 | HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only ... | The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of... | Class II | Arrow International Inc |
| Jul 9, 2018 | Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product U... | INOmeters affixed to the INOflo cylinders in Lot 17FP-0570 were programmed with an incorrect expi... | Class II | INO therapeutics LLC/dba ikaria |
| Jul 9, 2018 | Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillat... | Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabi... | Class II | Sorin CRM SAS |
| Jul 9, 2018 | Medtronic CD HORIZON Spinal System is intended to help provide immobilization... | This lot has incorrectly been laser marked both on the screw head itself as well as the data carr... | Class II | Medtronic Sofamor Danek USA Inc |
| Jul 9, 2018 | ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... | A nonsterile bulk product designated for further processing in a tray was inadvertently shipped t... | Class II | Merit Medical Systems, Inc. |
| Jul 9, 2018 | Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillat... | Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabi... | Class II | Sorin CRM SAS |
| Jul 6, 2018 | smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Ti... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System wi... | Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In th... | Class II | Neotract Inc |
| Jul 6, 2018 | 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use... | Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous ... | Class II | 3M Company - Health Care Business |
| Jul 6, 2018 | smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flare... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 6, 2018 | smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Fl... | "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires befo... | Class III | Smiths Medical ASD Inc. |
| Jul 5, 2018 | CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050 | the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during ... | Class II | CTL Medical Corporation |
| Jul 5, 2018 | DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest ... | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional ... | Class I | Pro-Med Instruments Gmbh |
| Jul 5, 2018 | DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percuta... | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional ... | Class I | Pro-Med Instruments Gmbh |
| Jul 5, 2018 | DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system ... | The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional ... | Class I | Pro-Med Instruments Gmbh |
| Jul 5, 2018 | CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050 | the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during ... | Class II | CTL Medical Corporation |
| Jul 4, 2018 | Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices. | The application may be closed by the operating system without alerting the user the app is no lon... | Class II | Medtronic Inc. |
| Jul 3, 2018 | Brilliance 64, 728231 Product Usage: Computed Tomography X-ray systems in... | Philips has identified that the compensator within the X-ray tube collimator may fail, resulting ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 3, 2018 | Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbo... | Vials labeled for the prescriptions contained incorrect lenses | Class III | Alden Optical |
| Jul 3, 2018 | Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems i... | Philips has identified that the compensator within the X-ray tube collimator may fail, resulting ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 3, 2018 | PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use... | Incorrect expiration being entered for one lot. | Class II | Abbott Vascular |
| 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 3, 2018 | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip AR... | One lot of product is from product code AK-22502 so it contains a 2-lumen, 5 Fr x 5 cm catheter.... | Class II | Arrow International Inc |
| Jul 3, 2018 | Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray system... | Philips has identified that the compensator within the X-ray tube collimator may fail, resulting ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 3, 2018 | Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarb... | Vials labeled for the prescriptions contained incorrect lenses | Class III | Alden Optical |
| Jul 3, 2018 | ABL800 analyzer, model numbers 393-800 and 393-801. | The analyzer software may cause a mis-match of patient demographics and test results when a certa... | Class II | Radiometer America 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 |
| Jul 2, 2018 | Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The devic... | Charging base may overheat with localized melting and sparking, possibly causing fire, shock or b... | Class II | Water Pik, Inc. |
| Jul 2, 2018 | Powder Free Vinyl Exam Gloves, Item Nos. 14-116, 14-118 Product Usage: Me... | The firm is recalling one lot of McKesson Powder Free Vinyl Exam Gloves because a sample of produ... | Class II | Cypress Medical Products LLC |
| Jul 2, 2018 | iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic ... | The device and its accessories may not have been manufactured according to current Good Manufactu... | Class II | Hudson Scientific LLC |
| Jun 29, 2018 | MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E The MAYFIELD... | There is a potential for the knob assembly in the swivel adapter to fracture/break during use. | Class II | Integra LifeSciences Corp. |
| Jun 29, 2018 | Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manua... | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the p... | Class II | Quasar Bio-Tech, Inc. |
| Jun 29, 2018 | Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual.... | Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the p... | Class II | Quasar Bio-Tech, Inc. |
| Jun 29, 2018 | MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFI... | There is a potential for the knob assembly in the swivel adapter to fracture/break during use. | Class II | Integra LifeSciences Corp. |
| Jun 29, 2018 | Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a mult... | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2018 | Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vi... | An incorrect control board and firmware installed in some of the Hand Held Barcode Scanners could... | Class II | Luminex Corporation |
| Jun 29, 2018 | Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-... | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2018 | RayStation stand-alone software treatment planning system, RayStation 4.5, R... | If the beam model has a highly asymmetric primary source, it is not correctly taken into account ... | Class II | RAYSEARCH LABORATORIES AB |
| Jun 29, 2018 | Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a ... | Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were id... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jun 29, 2018 | 3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product... | In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceilin... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 29, 2018 | Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indic... | The firm received a complaint where, during patient positioning, the technologist was adjusting t... | Class II | Hitachi Medical Systems America Inc |
| Jun 29, 2018 | 3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling... | In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceilin... | Class II | Siemens Medical Solutions USA, Inc |
| Jun 29, 2018 | MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity... | There is a potential for the knob assembly in the swivel adapter to fracture/break during use. | Class II | Integra LifeSciences Corp. |
| Jun 29, 2018 | MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Us... | QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QF... | Class II | Mevion Medical Systems, 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.