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 |
|---|---|---|---|---|
| Apr 4, 2018 | Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage:... | Tip of the curing light was too hot causing a heat sensation in the patients. | Class II | Handpiece Headquarters |
| Apr 4, 2018 | CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLS... | Unusually high number of total images/unassigned events may require additional time and effort fo... | Class II | Menarini Silicon Biosystems |
| Apr 3, 2018 | Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, ... | There is a potential dry blast irregularity on the locking collar screws packaged with the lockin... | Class II | Zimmer Biomet, Inc. |
| Apr 3, 2018 | Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570... | Service technician improperly documented final release testing on product, indicating that the fu... | Class II | Baxter Healthcare Corporation |
| Apr 3, 2018 | Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 3570... | Service technician improperly documented final release testing on product, indicating that the fu... | Class II | Baxter Healthcare Corporation |
| Apr 3, 2018 | Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 3570... | Service technician improperly documented final release testing on product, indicating that the fu... | Class II | Baxter Healthcare Corporation |
| Apr 3, 2018 | Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570... | Service technician improperly documented final release testing on product, indicating that the fu... | Class II | Baxter Healthcare Corporation |
| Apr 3, 2018 | Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 3570... | Service technician improperly documented final release testing on product, indicating that the fu... | Class II | Baxter Healthcare Corporation |
| Apr 3, 2018 | cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is ... | The syringe plunger on the device may be mounted in a tilted position, which applies mechanical s... | Class II | Roche Diagnostics Corporation |
| Apr 2, 2018 | PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The P... | The connector of the power supply was capable of fitting other components provided with the syste... | Class II | Bio-Rad Laboratories Inc |
| Apr 2, 2018 | Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, met... | Two lots of different sized modular heads potentially commingled. Risks include delay in surgery ... | Class II | Zimmer Biomet, Inc. |
| Apr 2, 2018 | T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercis... | A performance issue with customer owned spare parts, T2100 Microflex drive (2026182-002 or 202618... | Class II | GE Medical Systems Ultrasound & Primary Care Di... |
| Apr 2, 2018 | AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000... | Following pressurization of the devices, damage to the device handle mechanism may occur, accompa... | Class II | AESDEX |
| Apr 2, 2018 | AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog N... | Following pressurization of the devices, damage to the device handle mechanism may occur, accompa... | Class II | AESDEX |
| Apr 2, 2018 | Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/... | Two lots of different sized modular heads potentially commingled. Risks include delay in surgery ... | Class II | Zimmer Biomet, Inc. |
| Apr 2, 2018 | Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630 | There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor.... | Class II | Synthes (USA) Products LLC |
| Apr 2, 2018 | Bivona¿ Tracheostomy Tube Tracheostomy Tubes | Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as s... | Class II | Smiths Medical ASD Inc. |
| Apr 2, 2018 | Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623 | There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor.... | Class II | Synthes (USA) Products LLC |
| Mar 30, 2018 | smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, ... | The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... | Class II | Smith & Nephew, Inc. |
| Mar 30, 2018 | Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 7282... | The patient support head holder could contact the back ISO shelter wall during manual or motorize... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 30, 2018 | smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM,... | The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... | Class II | Smith & Nephew, Inc. |
| Mar 30, 2018 | Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in ... | Possible leak at distal open end of the strain relief, which causes medical staff to continue add... | Class II | Edwards Lifesciences, LLC |
| Mar 30, 2018 | C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System i... | The catheter alignment arrow printed onto the strain relief is not aligned with the detachment fe... | Class II | PENTAX of America Inc |
| Mar 30, 2018 | MR Surgical Suite Option Product The MR Surgical Option when integrated wi... | There is a potential safety issue with the table transfer release of the MR Surgical Suite System... | Class II | GE Medical Systems, LLC |
| Mar 30, 2018 | smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM,... | The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... | Class II | Smith & Nephew, Inc. |
| Mar 30, 2018 | Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product... | Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test re... | Class II | Immuno-Mycologics, Inc |
| Mar 30, 2018 | Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 72... | The patient support head holder could contact the back ISO shelter wall during manual or motorize... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 30, 2018 | Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 7282... | The patient support head holder could contact the back ISO shelter wall during manual or motorize... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 30, 2018 | smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, ... | The affected products were inadvertently packaged with the inner packaging pouch being sealed tog... | Class II | Smith & Nephew, Inc. |
| Mar 30, 2018 | Think Surgical Cutter, Flat, ¿6.2mm x 144mm. For use only with the TCAT Comp... | There is a potential for the cutter head to detach from the cutter shaft. | Class II | Think Surgical, Inc. |
| Mar 29, 2018 | Access Hi-Low Exam Tables, Model 6501-XX | One lot, the wire harness was over-crimped on some of the connectors that go to the two vertical ... | Class II | Brewer Company, LLC |
| Mar 29, 2018 | Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage:... | Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading ... | Class II | Cook Inc. |
| Mar 29, 2018 | iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iC... | The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufac... | Class II | Beckman Coulter Inc. |
| Mar 29, 2018 | Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM Product Usage:... | Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading ... | Class II | Cook Inc. |
| Mar 29, 2018 | Discovery IGS 740 Interventional Fluoroscopic X-ray Systems | The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in ... | Class II | GE Medical Systems, SCS |
| Mar 29, 2018 | Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Cathete... | Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (O... | Class II | Stryker Sustainability Solutions |
| Mar 29, 2018 | Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage:... | Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading ... | Class II | Cook Inc. |
| Mar 29, 2018 | Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number ... | There is a potential for debris in the hole on the superior lateral aspect of the device as a res... | Class II | Zimmer Biomet, Inc. |
| Mar 29, 2018 | Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage... | Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading ... | Class II | Cook Inc. |
| Mar 29, 2018 | Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage... | Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading ... | Class II | Cook Inc. |
| Mar 29, 2018 | Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Us... | Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading ... | Class II | Cook Inc. |
| Mar 29, 2018 | Discovery IGS 730 Interventional Fluoroscopic X-ray Systems | The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in ... | Class II | GE Medical Systems, SCS |
| Mar 29, 2018 | Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems | The Discovery IGS and Innova IGS systems may experience X-ray abort errors which could result in ... | Class II | GE Medical Systems, SCS |
| Mar 28, 2018 | Gentle Threads, Interference Screw; Model No. 905615, 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 | Gentle Threads, Interference Screw; Model No. 905617, 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 | RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 ... | The dose calculation accuracy may in some situations be less than expected. The user must be awar... | Class II | RAYSEARCH LABORATORIES AB |
| Mar 28, 2018 | Ingenuity Core128/Elite China 728324 | 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. 905607, 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 | Gentle Threads, Interference Screw; Model No. 905608, 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 | Gentle Threads, Interference Screw; Model No. 905605, for soft tissue reattac... | Specific lots of the device were overexposed during EtO sterilization. This may lead to revision ... | 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.