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 Target Detachable Coils: TARGET 360 NANO 2MM X 3CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET 360 NANO 2MM X 4CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET 360 NANO 3MM X 4CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET 360 NANO 3MM X 6CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET HELICAL NANO 2MM X 6CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 3CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET HELICAL NANO 3MM X 6CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Connecticut, District of Columbia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, New York, Pennsylvania and Texas named
- Medical device recall Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Connecticut, District of Columbia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, New York, Pennsylvania and Texas named
- Medical device recall Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Connecticut, District of Columbia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, New York, Pennsylvania and Texas named
- Medical device recall Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Connecticut, District of Columbia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, New York, Pennsylvania and Texas named
- Medical device recall Part #311.039, Handle with Mini QC Small DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Connecticut, District of Columbia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, New York, Pennsylvania and Texas named
- Medical device recall Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Connecticut, District of Columbia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, New York, Pennsylvania and Texas named
- Medical device recall Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Connecticut, District of Columbia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, New York, Pennsylvania and Texas named
- Medical device recall Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Connecticut, District of Columbia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, New York, Pennsylvania and Texas named
- Medical device recall Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Connecticut, District of Columbia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, New York, Pennsylvania and Texas named
- Medical device recall Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Connecticut, District of Columbia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, New York, Pennsylvania and Texas named
- Medical device recall Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Connecticut, District of Columbia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, Montana, New York, Pennsylvania and Texas named
- Medical device recall Medtronic, Temporary Pacing Lead System This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding provisions of FDA 21 CFR 898, which relate to design standards… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Guam and US Virgin Islands named
- Medical device recall Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675 Labeling error. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereKentucky and Tennessee
- Medical device recall Femoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675 Labeling error. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereKentucky and Tennessee
- Medical device recall cobas¿ Liat Influenza A/B Quality Control Kit Kit labeled with the incorrect expiration date. Class IIIFDA’s classJul 20, 2016in FDA’s Enforcement Report16 statesnamed in where it went PublishedJul 20, 2016ClassClass IIIStatusTerminatedWhereAlaska, Hawaii, Iowa, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Montana, North Carolina, New York, Oregon, Pennsylvania, Texas, Virginia and Washington
- Medical device recall 5.0mm Round Fluted Bur, Super Long Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereCalifornia, Illinois and South Dakota
- Medical device recall 6.0mm Round Fluted Bur, Super Long Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled… Class IIFDA’s classJul 20, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereCalifornia, Illinois and South Dakota
- Medical device recall Mammotome Revolve Dual Vacuum Assist Biopsy System A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package. Class IIFDA’s classJul 20, 2016in FDA’s Enforcement Report26 statesnamed in where it went PublishedJul 20, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Washington and Wisconsin
- Medical device recall ABG-HM-1 Hummi Micro Draw Blood Transfer Device Hummingbird Med Devices, Inc. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 13, 2016in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJul 13, 2016ClassClass IStatusTerminatedWhereCalifornia
- Medical device recall Musculoskeletal Transplant Foundation, AFT Diverted Tube AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an unsealed Tyvek pouch. Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic 0-arm Imaging mobile x-ray system It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of… Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Navigation O-arm 02 surgical x-ray imaging system Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the… Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS… Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Class IIIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 13, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall The ZYTO Tower is the input device to program the software with various virtual items. ZYTO Technologies Inc. Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response… ZYTO Technologies Inc. Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Cytosponge Cell Collection Kit Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during… Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Minnesota, North Carolina, New York, Oregon and Tennessee
- Medical device recall Covidien Cytosponge Cell Collection Device Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two reports of the device detaching from the removal string during… Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Minnesota, North Carolina, New York, Oregon and Tennessee
- Medical device recall Magnetic Resonance System G-scan Brio (Part Number /Model No.101002000) The device is being recalled because dynamic loading forces from larger patients can fracture the extremity portion of the patient table. Class IIFDA’s classJul 13, 2016in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereFlorida, Minnesota, Nevada, Ohio and Texas
- Medical device recall Medtronic, MyCareLink Patient Monitor Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Monitors. Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc. Has the incorrect operating directions on the mode switch ring, i.e. Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportVirginiathe one state its words name PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereVirginia
- Medical device recall Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17 Labeled with the incorrect Global Trade Item Number (GTIN). Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Hawaii, Maine, New York and Oklahoma named
- Medical device recall Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18 Labeled with the incorrect Global Trade Item Number (GTIN). Class IIFDA’s classJul 13, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 13, 2016ClassClass IIStatusTerminatedWhereNationwide, and Hawaii, Maine, New York and Oklahoma named
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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