Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, 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 5, 2026.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 3 CC L/L 21 G X 1.5, 100 per box, 24 boxes/case, 2,400/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.25, 100 per box, 24 boxes/case, 2,400/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.5, 100 per box, 24 boxes/case, 2,400/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 3 CC L/L 23 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 3 CC L/L 25 G X 5/8, 100 per box, 24 boxes/case, 2,400/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 5 CC L/L 20 G X 1.5, 100 per box, 15 boxes/case, 1,500/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 5 CC L/L 21 G X 1.5, 100 per box, 15 boxes/case, 1,500/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.0, 100 per box, 15 boxes/case, 1,500/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 5 CC L/L 22 G X 1.5, 100 per box, 15 boxes/case, 1,500/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.0, 100 per box, 10 boxes/case, 1,000/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 10 CC L/L 20 G X 1.5, 100 per box, 10 boxes/case, 1,000/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.0, 100 per box, 10 boxes/case, 1,000/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 10 CC L/L 21 G X 1.5, 100 per box, 10 boxes/case, 1,000/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.0, 100 per box, 10 boxes/case, 1,000/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe and Hypodermic Needle, 10 CC L/L 22 G X 1.5, 100 per box, 10 boxes/case, 1,000/case The… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe, 1 CC L/S, 100 per box, 40 boxes/case, 4,000/case The products are used to inject fluids into,… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe, 3 CC L/L, 100 per box, 30 boxes/case, 3,000/case The products are used to inject fluids into,… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe, 3 CC L/S, 100 per box, 30 boxes/case, 3,000/case The products are used to inject fluids into,… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe, 5 CC L/L, 100 per box, 20 boxes/case, 2,000/case The products are used to inject fluids into,… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe, 5 CC L/S, 100 per box, 20 boxes/case, 2,000/case The products are used to inject fluids into,… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe, 10 CC L/L, 100 per box, 12 boxes/case, 1,200/case The products are used to inject fluids… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe, 10 CC L/S, 100 per box, 12 boxes/case, 1,200/case The products are used to inject fluids… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe, 20 CC L/L, 100 per box, 9 boxes/case, 900/case The products are used to inject fluids into,… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe, 20 CC L/S, 100 per box, 9 boxes/case, 900/case The products are used to inject fluids into,… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe, 30 CC L/L, 50 per box, 9 boxes/case, 450/case The products are used to inject fluids into, or… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe, 30 CC L/S, 50 per box, 9 boxes/case, 450/case The products are used to inject fluids into, or… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe, 60 CC L/L, 50 per box, 8 boxes/case, 400/case The products are used to inject fluids into, or… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Piston Syringe, 60 CC L/S, 50 per box, 8 boxes/case, 400/case The products are used to inject fluids into, or… Insufficient documentation to support product sterility claims. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Washington named
- Medical device recall Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in Identification of excess plastic on the tip of the cannula. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New York, Oklahoma, Pennsylvania, South Dakota, Texas and Virginia named
- Medical device recall BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product’s sterile barrier. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Illinois, Indiana, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Texas and Wyoming named
- Medical device recall PALLAS M/MAXIMIS 5.5 mm Instrument Tap Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS 50mm Curved Rod Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS 60mm Curved Rod Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Crosslink 50-70mm Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Small Crosslink Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS Large Crosslink Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS 5.5 x 05mm Curved Rod Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS 5.5 x 35mm Curved Rod Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS MIS Poly Screw Driver B Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS 30mm Rod Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS 35mm MIS rod Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS 40mm MIS rod Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia named
- Medical device recall PALLAS M/MAXIMIS 45mm MIS Devices are not consistent with Quality System Requirements. Class IIFDA’s classAug 16, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 16, 2017ClassClass IIStatusTerminatedWhereNationwide, and California and Virginia 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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