Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-04-24FDA-DeviceProSun International, LLCClass IIProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IITalar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IITalar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IITalar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IITalar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IITalar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IITalar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IITalar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IITalar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IITalar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IITalar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IITalar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IITalar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IITalar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IITalar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IITibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IITibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IITibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IITibial Total Ankle Prosthesis Tray, Size 0, Product No. LJU220T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IISalto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No. LJU213T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IISalto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, Part No. LJU212T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IISalto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IISalto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, Part No. LJU210T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IISalto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, Part No. LJU203T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IISalto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IISalto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceIntegra LifeSciences Corp.Class IISalto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No. LJU200T
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- 2019-04-24FDA-DeviceMedical Components, Inc dba MedCompClass II14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
- 2019-04-24FDA-DeviceBioventus, LLCClass IIBIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sold under the brand names of: SIGNAFUSE, OSTEOFUSE and MEDLINE UNITE.
The firm became aware of the potential for the products' sterile pouch to be punctured during transit. The packaging failure may introduce a non-sterile device that may lead to patient infection.
- 2019-04-24FDA-DeviceRoche Diagnostics CorporationClass IITina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on automated clinical chemistry analyzers analyzers.
New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***
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