Medical devices, 2016
Shortlist up to four to read them side by side.
3,246 medical device recalls FDA’s Enforcement Report published in 2016, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 7, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality… Studies that are viewed in iConnect Access that originate on Merge PACS / Ortho PACS may not display the correct current patient demographics if there has been… Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUARD Peripheral Vascular Patch. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510 Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512 Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker AutoPlex System The Piston Head can become separated from the Delivery Piston, blocking the injection assembly Valve resulting in a cement backflow towards the injector handle. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Weck EFx Classic Fascial Closure System Incorrect expiration date was printed on the product label. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Iowa, Kansas, Maryland, Michigan, North Carolina, New York and Pennsylvania named
- Medical device recall TRYX Antibacterial Envelope TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers… TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted… TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xario 100 Diagnostic Ultrasound System, TUS-X100 Toshiba American Medical Systems (TAMS) is recalling the Xario Diagnostics Ultrasound System because it may become hot because of a software error. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile Wire which deploys the loop may be come detached at the handle causing the device to be inoperable Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm Wire which deploys the loop may be come detached at the handle causing the device to be inoperable Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 1.5 mm HYDRO LeMaitre Valvulotome, 40 cm Wire which deploys the loop may be come detached at the handle causing the device to be inoperable Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS). Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedAug 24, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Bard TruGuide Disposable Coaxial Biopsy Needle Mixed Product May contain two trocar tip stylets with coaxials or two blunt tip stylets instead of one of each. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Iowa, Illinois, Louisiana, Massachusetts, Missouri, Pennsylvania, South Carolina and Virginia named
- Medical device recall Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert… Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement Report24 statesnamed in where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Indiana, Maryland, Maine, Missouri, Mississippi, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington
- Medical device recall Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing,… Mindray has identified a potential leakage issue with the CO2 Module’s Dryline II Water Trap used with the Passport Series Patient Monitor. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Quattro Air FFM MED AMER Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merge Unity Z3D software The software is unable to accurately determine the calcium score of scans with a slice thickness not equal to 3 mm. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereCalifornia, Montana, Pennsylvania and Texas
- Medical device recall ReShape Integrated Dual Balloon System, Gen 1 Due to a suspected misalignment of the connection between the proximal balloon cap of the implant and the delivery catheter. Class IIFDA’s classAug 24, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereCalifornia, New York and Ohio
- Medical device recall METS SMILES Total Knee Replacement The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the… Class IIFDA’s classAug 24, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereAlabama, Mississippi and Texas
- Medical device recall Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3” Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6” Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Straight Spatula Electrode 36C Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Curved Spatula Electrode 36CM Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Curved Spatula Electrode 45CM Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Wire J-Hook Electrode 36CM Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Wire J-Hook Electrode 36CM Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Wire J-Hook Electrode 45CM Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Flat L-Hook Electrode 36CM Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Straight Spatula Electrode 28CM Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Curved Spatula Electrode 28CM Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Wire J-Hook Electrode 28CM Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Wire L-Hook Electrode 28CM Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Wire L-Hook Electrode Retractable Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Wire L-Hook Electrode Retractable Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Flat L-Hook Electrode 28cm Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Flat L-Hook Electrode Retractable Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Valleylab Laparoscopic Cylindrical Tip Electrode 28CM Potential for compromise of the package resulting in a breach of the sterile barrier Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System… While merging exams in a test instance, merges carry forward in the production system, when the middle tier is configured to the wrong IP address of the… Class IIFDA’s classAug 24, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 24, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device… A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves falling… Class IIIFDA’s classAug 24, 2016in FDA’s Enforcement Report9 statesnamed in where it went PublishedAug 24, 2016ClassClass IIIStatusTerminatedWhereArkansas, Georgia, Kentucky, Minnesota, Oklahoma, South Dakota, Tennessee, Virginia and West Virginia
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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