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 6, 2026.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Endoscopic Introducer/Extractor reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning,… Class IIFDA’s classJun 21, 2017in FDA’s Enforcement Report31 statesnamed in where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Vue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied… Cook Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereFlorida, Indiana, Louisiana, Mississippi, North Carolina and Texas
- Medical device recall Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number:… Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Sutures. MAXON: MAXON 4/0 5X18” GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH;… Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48” U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48”… Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Sutures. BIOSYN: BIOSYN 4/0 18” VIOLET CV-25 DT, Item Number: GMJ34M Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Best Practice Kit Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall USPACK-SUTURE KIT Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CUSTOM SUTURE PACK Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall SCHRITTMACHER ANGIO X3 Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fem IM Nail 16mmdx40cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fem IM Nail 16mmdx42cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fem IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fem IM Nail 16mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fem IM Nail 16mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fem IM Nail 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fem IM Nail 16mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fem IM Nail 14mmdx48cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fem IM Nail 14mmdx50cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fem IM Nail 14mmdx50cm right, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Segmental malefemale taper, 200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/polymer constrained cemented… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Segmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Segmental fluted stem, 18x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Segmental fluted stem, 19x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Segmental fluted stem, 15x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Segmental fluted stem, 17x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Segmental fluted stem, 18x250mm bwd, Sterile Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee,… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, semi-constrained, cemented or… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Por fullct fem st 15x200mm, Sterile, prosthesis, hip, semi-constrained, metal/polymer, porous uncemented-… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Por fullct fem st 16x200mm, Sterile Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Por fullct fem st 17x200mm, Sterile Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Por fullct fem st 18x200mm, Sterile Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee,… Zimmer Biomet Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth… Contamination of product with possible Bacillus spp Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and New Jersey, New York and Wisconsin named
- Medical device recall OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages… Cook Inc. Class IIFDA’s classJun 21, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedJun 21, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Washington and Wisconsin 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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