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 |
|---|---|---|---|---|
| Jan 26, 2018 | Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray di... | Error introduced into PET images acquired and reconstructed with VJ20A software. Array values ar... | Class II | Siemens Medical Solutions USA, Inc. |
| Jan 26, 2018 | bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST ... | Customer reports indicated an increase in the rate of non-detected MRSA in association with the V... | Class I | bioMerieux, Inc. |
| Jan 26, 2018 | Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam f... | When switching from Pencil Beam Scanning treatment mode to Uniform Scanning treatment mode, the t... | Class II | Ion Beam Applications S.A. |
| Jan 25, 2018 | Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW wit... | Potential that one or more image series may be missing from an exam without a user warning disp... | Class II | GE Healthcare |
| Jan 25, 2018 | O-arm 1000 mobile image-intensified fluoroscopic x-ray system; (1) Model: BAS... | Software update ("SW Update 3.2.1") is being implemented to address the following issues: Inabili... | Class II | Medtronic Navigation, Inc.-Littleton |
| Jan 25, 2018 | CMI (Collagen Meniscus Implant) device, Ivy Sports Medicine s collagen-based ... | The recalled products were shipped without the required temperature control packaging, therefore ... | Class II | Stryker Corporation |
| Jan 25, 2018 | Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricit... | Potential that one or more image series may be missing from an exam without a user warning disp... | Class II | GE Healthcare |
| Jan 24, 2018 | Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usa... | The recalling firm identified a software issue related to the Patient Line Check (PLC) which may ... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Jan 24, 2018 | Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended... | The cutting edge of tissue punches may be potentially damaged with small dents and nicks. | Class II | Keystone Dental Inc |
| Jan 24, 2018 | Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: ... | Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluen... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jan 24, 2018 | DynaCad software consist of an MR Analysis Server software and the viewer wor... | Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not... | Class II | Invivo Corporation |
| Jan 24, 2018 | Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 3... | One lot of humeral stem implants do not include the humeral bushing components. | Class II | Zimmer Biomet, Inc. |
| Jan 24, 2018 | VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2 | Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 program... | Class II | LivaNova USA Inc |
| Jan 24, 2018 | Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; P... | Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluen... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jan 23, 2018 | bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system c... | Missing desiccant. | Class II | Biomerieux Inc |
| Jan 23, 2018 | 3M Bair Hugger(M) Normothermia System, Sterile Full Access Underbody, Model 6... | Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and ... | Class II | 3M Company - Health Care Business |
| Jan 23, 2018 | 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket,... | Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and ... | Class II | 3M Company - Health Care Business |
| Jan 23, 2018 | Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0m... | InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jan 22, 2018 | Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A ... | DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valv... | Class II | DeRoyal Industries Inc |
| Jan 22, 2018 | Apollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors... | The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated... | Class II | Valeris Medical, LLC |
| Jan 22, 2018 | DS Titanium Ligation Clip Appliers, used in laparoscopic surgery | Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added o... | Class II | Aesculap Implant Systems LLC |
| Jan 22, 2018 | DS Titanium Ligation Clip, used in laparoscopic surgery | Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added o... | Class II | Aesculap Implant Systems LLC |
| Jan 21, 2018 | The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femto... | This Correction is being initiated based on a customer complaint received on November 16, 2017 wh... | Class II | SIE AG, Surgical Instrument Engineering |
| Jan 20, 2018 | Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: Th... | The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and... | Class II | Hologic, Inc |
| Jan 19, 2018 | Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provi... | Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for... | Class II | Terumo Cardiovascular Systems Corporation |
| Jan 19, 2018 | AutoMate 1200 Catalog Number ODL25120; AutoMate 1250 Catalog Number ODL25125... | Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing pr... | Class II | Beckman Coulter Inc. |
| Jan 19, 2018 | Restoris MCK Onlay Insert Extractor. | Possible hinge pin disassociation from the Mako Onlay Insert Extractor. | Class II | Mako Surgical Corporation |
| Jan 19, 2018 | SwishTapered Implant Intended for use in support for fixed bridgework. | The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been package... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jan 19, 2018 | SwishPlus Implant Intended for use in support for fixed bridgework. | The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been package... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jan 19, 2018 | InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC | Insulin syringe retail packages incorrectly labeled as "Short Needle". | Class II | Allison Medical, Inc. |
| Jan 18, 2018 | Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25... | The implant size is incorrectly etched on the implant. The size listed on the box is correct. | Class II | Neuropro Spinal Jaxx |
| Jan 18, 2018 | AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standar... | A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to caus... | Class II | Beckman Coulter Inc. |
| Jan 18, 2018 | Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in F... | NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in a... | Class II | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Jan 17, 2018 | Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version... | Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Ce... | Class II | Spacelabs Healthcare Inc |
| Jan 17, 2018 | Uretero-reno fiberscope URF-P6 | Breakage of the endoscope's insertion tube bending section during surgical procedures. | Class II | Olympus Corporation of the Americas |
| Jan 17, 2018 | Uretero-reno fiberscope URF-P6RP6 | Breakage of the endoscope's insertion tube bending section during surgical procedures. | Class II | Olympus Corporation of the Americas |
| Jan 17, 2018 | Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R | Potential breakage of the endoscope s insertion tube bending section during surgical procedures | Class II | Olympus Corporation of the Americas |
| Jan 16, 2018 | Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter... | Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alo... | Class II | Medtronic Perfusion Systems |
| Jan 16, 2018 | Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 ... | Possible sterile barrier breach in the pouch of Affinity NT Cardiotomy Venous Reservoir stand alo... | Class II | Medtronic Perfusion Systems |
| Jan 15, 2018 | LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71... | The affected products were inadvertently packaged with an incorrect screw component. | Class II | Smith & Nephew, Inc. |
| Jan 12, 2018 | COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM ... | A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or ... | Class I | Beckman Coulter Inc. |
| Jan 12, 2018 | MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is ... | The temperature of the incubation lids of the MINC Bench top Incubators may become too high or to... | Class II | Cook Inc. |
| Jan 12, 2018 | Solid state x-ray imager (flat panel/digital imager) Solid state x-ray i... | While transporting the portable machine with the retrofit equipment in a backwards motion, there ... | Class II | NeuroLogica Corporation |
| Jan 12, 2018 | Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol S... | Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1... | Class II | Tecan US, Inc. |
| Jan 12, 2018 | Custom Pak¿ (Custom Pak in which Alcon 25+¿ TOTALPLUS¿ Vitrectomy Pak is a c... | Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+... | Class II | Alcon Research, LTD. |
| Jan 12, 2018 | Progressa Bed - AC-powered adjustable hospital bed | A component used within the braking system may break resulting in one or more brake pedals on the... | Class II | Hill-Rom, Inc. |
| Jan 12, 2018 | Alcon 25+¿ TOT ALPLUS¿ Vitrectomv Pak Includes all necessary items for a c... | Alcon is conducting this Voluntary Medical Device Recall for a specific lot (2060953H) of its 25+... | Class II | Alcon Research, LTD. |
| Jan 12, 2018 | Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiograp... | When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or ch... | Class II | Shimadzu Medical Systems |
| Jan 12, 2018 | 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 M... | A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or ... | Class I | Beckman Coulter Inc. |
| Jan 12, 2018 | Artis one fluoroscopic x-ray system and patient table Artis one is an an... | Certain patient table systems may have a missing or incorrectly installed snap ring that could ca... | Class II | Siemens Medical Solutions USA, 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.