Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular… Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater than 30 minutes for the Modular Screw Driver (PN… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during… Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be used during… Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump system due to reports of pump speed control knob failures resulting… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Codman Certas Programmable Valve In Line Valve Only Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and… Codman Certas Programmable Valves used for hydrocephalus may not operate properly Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Centricity Laboratory System is intended to be an information system designed to support the clinical and… GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Laboratory Core Lab calculated results in two scenarios. Class IIIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 5, 2014ClassClass IIIStatusTerminatedWhereNationwide, and California, Georgia and Minnesota named
- Medical device recall SET SCREW RETAINING DRIVER The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Michigan, North Carolina, New Jersey and Texas
- Medical device recall T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626 Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall T3F, Free T3 Assay, REF/Catalog Number L2KF32 Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD BACTEC FX- Top Unit instrument Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD BACTEC FX 40 instrument Improperly functioning component of a diagnostic medical device may cause false negative results in clinical specimens. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARIATELE TELEMETRY TRANSMITTER The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because the AriaTele (transmitter) display and the Telemetry Central Station display may… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Iowa, Illinois, Louisiana, Massachusetts, Maine, Michigan, Missouri, Mississippi, New York, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570 Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 56.07.23P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, sterile / EO, 56.07.25PS Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.30.P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile / EO, 56.30.23P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, 56.50.29P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft, sterile / EO, 56.52.25P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, sterile / EO, 56.55.27P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5 ft, sterile / EO, 55.62.23P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02 Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft, sterile / EO, 56.02.23P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stiff 25ga Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.25PS Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall “The Corona” Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, length 7.0 ft, sterile / EO, 56.12 Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 25ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetics, inc., 19ga, length 7.0 ft,… Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO, 56.20P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Wide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., 20ga, length 7.5 ft,… Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.21.23P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.25P Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R Reports of physicians experiencing inability to pass a 0.035” guidewire through the guidewire lumen and exit port at the (proximal) Y-manifold of the imaging… Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Radial Assist RAD BOARD, used to support the weight of a patient’s arm and supplies for a medical procedure Merit Medical Systems, Inc. Class IIFDA’s classFeb 5, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedFeb 5, 2014ClassClass IIStatusTerminatedWhereGeorgia, Minnesota, New Jersey, Texas and West Virginia
- Medical device recall XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external… When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should… Class IIFDA’s classJan 29, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedJan 29, 2014ClassClass IIStatusTerminatedWhereIllinois, Indiana, Louisiana, New Jersey, Texas, Washington and Wisconsin
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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