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 6, 2026.
2,249of 2,249 medical device recallsshown with your filters
The list
- Medical device recall Presource PBDS, Extremity, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 15, 2013ClassClass IStatusTerminatedWhereArkansas, Mississippi, South Carolina and Tennessee
- Medical device recall Presource PBDS, Hand, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 15, 2013ClassClass IStatusTerminatedWhereArkansas, Mississippi, South Carolina and Tennessee
- Medical device recall Presource PBDS, Shoulder Arthroscopy, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 15, 2013ClassClass IStatusTerminatedWhereArkansas, Mississippi, South Carolina and Tennessee
- Medical device recall Presource PBDS, Shoulder Procedure, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 15, 2013ClassClass IStatusTerminatedWhereArkansas, Mississippi, South Carolina and Tennessee
- Medical device recall Presource PBDS, Total Hip, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 15, 2013ClassClass IStatusTerminatedWhereArkansas, Mississippi, South Carolina and Tennessee
- Medical device recall Presource PBDS, Total Joint, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 15, 2013ClassClass IStatusTerminatedWhereArkansas, Mississippi, South Carolina and Tennessee
- Medical device recall Presource PBDS, Total Knee, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 15, 2013ClassClass IStatusTerminatedWhereArkansas, Mississippi, South Carolina and Tennessee
- Medical device recall Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 15, 2013ClassClass IStatusTerminatedWhereArkansas, Mississippi, South Carolina and Tennessee
- Medical device recall Presource PBDS, Knee Arthroscopy, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 15, 2013ClassClass IStatusTerminatedWhereArkansas, Mississippi, South Carolina and Tennessee
- Medical device recall BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, New Jersey and Texas
- Medical device recall KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II,… The recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D-Light C System instruction manuals have important… Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Iowa, Illinois, Maryland, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Wisconsin and West Virginia named
- Medical device recall Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal Finish The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, Metal Finish The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal Finish The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal Finish The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal Finish The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal Finish The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflective Finish The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective Finish The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflective Finish The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflective Finish The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with 30¿ Downward Bend At Proximal End The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-Reflective Finish The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Vented, Metal Finish The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal Finish The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis… The Trial Head may come loose from the implant stem during manipulation of the arm during surgery. Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Indiana, Massachusetts, Michigan, Missouri, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Unable to pass catheter through outer sheath during embryo transfer Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Obturator Unable to pass catheter through outer sheath during embryo transfer Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Wallace Sure-Pro Ultra¿ Embryo Replacement Catheter with Stylet Unable to pass catheter through outer sheath during embryo transfer Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro¿ Embryo Replacement… Unable to pass catheter through outer sheath during embryo transfer Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter for difficult transfer with Stylet PPS623 Sure-Pro¿… Unable to pass catheter through outer sheath during embryo transfer Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Wallace Sure-Pro¿ Single Stage Embryo Replacement Catheter Unable to pass catheter through outer sheath during embryo transfer Class IIFDA’s classMay 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 15, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
- Medical device recall Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. Class IIIFDA’s classMay 15, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 15, 2013ClassClass IIIStatusTerminatedWhereOhio and Pennsylvania
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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