Medical devices, 2013
Shortlist up to four to read them side by side.
2,249 medical device recalls FDA’s Enforcement Report published in 2013, 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.
2,249of 2,249 medical device recallsshown with your filters
The list
- Medical device recall Sarns high-flow aortic arch cannula, 5.2 mm Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded… Class IIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Missouri, North Carolina, North Dakota, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Sarns high-flow aortic arch cannula, 6.5 mm Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded… Class IIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Missouri, North Carolina, North Dakota, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Sarns high-flow aortic arch cannula, 6.5 mm Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded… Class IIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Missouri, North Carolina, North Dakota, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Bausch and Lomb 27G sterile cannula Some disposable cannulas (with 4-digit lot numbers) provided with the Amvisc or Amvisc Plus OVD are not properly engaging to the Luer-Lock on the Amvisc and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 23, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 23, 2013ClassClass IStatusTerminatedWhereDistrict of Columbia and Puerto Rico
- Medical device recall Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor… Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJan 23, 2013ClassClass IStatusTerminatedWhereNationwide, and Florida, Illinois, New Jersey, Ohio, Pennsylvania and Texas named
- Medical device recall Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 Software anomalies. Class IIFDA’s classJan 23, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereIndiana, Ohio and Oregon
- Medical device recall Computed Tomography X-Ray System Brilliance Workspace Portal Philips was notified that when performing post processing with the Brilliance Workspace Portal platform with software versions 2.6.1.4, the coronary arteries… Class IIFDA’s classJan 23, 2013in FDA’s Enforcement Report17 statesnamed in where it went PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Illinois, Indiana, Massachusetts, Maine, Michigan, Missouri, North Carolina, New Jersey, New York, Oregon, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL GranuFlo Dry Acid Concentrate may show discoloration Class IIIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL GranuFlo Dry Acid Concentrate may show discoloration Class IIIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL GranuFlo Dry Acid Concentrate may show discoloration Class IIIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL GranuFlo Dry Acid Concentrate may show discoloration Class IIIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL GranuFlo Dry Acid Concentrate may show discoloration Class IIIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL GranuFlo Dry Acid Concentrate may show discoloration Class IIIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL GranuFlo Dry Acid Concentrate may show discoloration Class IIIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL GranuFlo Dry Acid Concentrate may show discoloration Class IIIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL GranuFlo Dry Acid Concentrate may show discoloration Class IIIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall DePuy Spine EXPEDIUM Offset Torque Wrench A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values… Class IIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030 Truncated V-Bottomed Microplate Wells used in assays contain defective wells. Class IIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U Truncated V-Bottomed Microplate Wells used in assays contain defective wells. Class IIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B Truncated V-Bottomed Microplate Wells used in assays contain defective wells. Class IIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010 Truncated V-Bottomed Microplate Wells used in assays contain defective wells. Class IIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Microplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465 Truncated V-Bottomed Microplate Wells used in assays contain defective wells. Class IIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and… Quanta System S.p.A, Italy, is notifying U.S. Class IIFDA’s classJan 23, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereArizona, Colorado, Oregon and Texas
- Medical device recall Eterna Giovinezza System, Powered Laser Surgical Instrument Quanta System S.p.A, Italy, is notifying U.S. Class IIFDA’s classJan 23, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereArizona, Colorado, Oregon and Texas
- Medical device recall Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument Quanta System S.p.A, Italy, is notifying U.S. Class IIFDA’s classJan 23, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereArizona, Colorado, Oregon and Texas
- Medical device recall Spacelabs Smart Disclosure System Displaying or printing of an incorrect waveform for the time indicated in the printout or display in the Spacelabs Healthcare Intesys Clinical Suite (ICS) G2,… Class IIFDA’s classJan 23, 2013in FDA’s Enforcement Report12 statesnamed in where it went PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Iowa, Illinois, Louisiana, Michigan, Minnesota, North Carolina, Puerto Rico, South Carolina, Texas and Washington
- Medical device recall Hoffman LRF Wire Bolt Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients. Class IIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, New York, Ohio and Pennsylvania named
- Medical device recall 25-Hydroxy Vitamin D EIA Immunodiagnostic Systems is recalling the 25-Hydroxy Vitamin D EIA, AC-57F1 because the QC report was found to have an erroneous calibrator value assigned. Class IIFDA’s classJan 23, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 23, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than… Class IIIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than… Class IIIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Siemens Chek-Stix Combo Pak When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than… Class IIIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than… Class IIIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Siemens Chek-Stix Combo Pak (Distributed OUS only) When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than… Class IIIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Siemens Chek-Stix Combo Pak (Distributed OUS only) When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than… Class IIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens Chek-Stix Combo Pak (Distributed OUS) When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than… Class IIIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Philips HeartStart FRx 861304 Automated External Defibrillator Philips determined that it is important to clarify information in the Owner’s Manual and keep customers informed about the maintenance of their FRx (models… Class IIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Philips determined that it is important to clarify information in the Owner’s Manual and keep customers informed about the maintenance of their FRx (models… Class IIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Laparoscope, general Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. Class IIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ABX PENTRA ML, Software Versions: V8.0.x and Below Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. Class IIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Indiana and Michigan named
- Medical device recall Immunoradiometric assay The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH… Class IIIFDA’s classJan 16, 2013in FDA’s Enforcement Report8 statesnamed in where it went PublishedJan 16, 2013ClassClass IIIStatusTerminatedWhereCalifornia, Georgia, Illinois, Indiana, Michigan, Minnesota, New York and Puerto Rico
- Medical device recall Immunoradiometric assay. The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH… Class IIIFDA’s classJan 16, 2013in FDA’s Enforcement Report8 statesnamed in where it went PublishedJan 16, 2013ClassClass IIIStatusTerminatedWhereCalifornia, Georgia, Illinois, Indiana, Michigan, Minnesota, New York and Puerto Rico
- Medical device recall Immunoradiometric assay The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH… Class IIIFDA’s classJan 16, 2013in FDA’s Enforcement Report8 statesnamed in where it went PublishedJan 16, 2013ClassClass IIIStatusTerminatedWhereCalifornia, Georgia, Illinois, Indiana, Michigan, Minnesota, New York and Puerto Rico
- Medical device recall Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the… California Medical Laboratories, Inc. Class IIFDA’s classJan 16, 2013in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Louisiana and Mississippi
- Medical device recall Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were California Medical Laboratories, Inc. Class IIFDA’s classJan 16, 2013in FDA’s Enforcement Report6 statesnamed in where it went PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Louisiana and Mississippi
- Medical device recall Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Surgical Tissue Network Inc., DBA TissueNet Inc. Class IIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc Surgical Tissue Network Inc., DBA TissueNet Inc. Class IIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Surgical Tissue Network Inc., DBA TissueNet Inc. Class IIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall FlowGate Balloon Guide Catheter Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration. Class IIFDA’s classJan 16, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJan 16, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Oregon and Tennessee 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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