Medical device recalls

39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.

2020-06-10FDA-DeviceBaxter Healthcare CorporationClass II
Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Potential disconnection of tubing set.
2020-06-10FDA-DeviceBaxter Healthcare CorporationClass II
Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Potential disconnection of tubing set.
2020-06-10FDA-DeviceBaxter Healthcare CorporationClass II
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Potential disconnection of tubing set.
2020-06-10FDA-DeviceBaxter Healthcare CorporationClass II
Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Potential disconnection of tubing set.
2020-06-10FDA-DeviceAbbott Diagnostics Technologies ASClass II
Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116971, 1116985, 1116986, IVD. The firm name on the label is Abbott Diagnostics Technologies AS, Oslo, Norway. Power supply provided with Alere Afinion AS100 Analyzer, Catalog numbers 1115175, 1115390, 1116049, 1116050, 1116053, 1116054, 1116456, and 1116980. The firm name on t
The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.
2020-06-10FDA-DeviceOsteomed, LLCClass II
OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-06-10FDA-DeviceOsteomed, LLCClass II
OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-06-10FDA-DeviceOsteomed, LLCClass II
OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-06-10FDA-DeviceOsteomed, LLCClass II
OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-06-10FDA-DeviceOsteomed, LLCClass II
OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-06-10FDA-DeviceOsteomed, LLCClass II
OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-06-10FDA-DeviceOsteomed, LLCClass II
OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-06-10FDA-DeviceOsteomed, LLCClass II
OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-06-10FDA-DeviceOsteomed, LLCClass II
OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-06-10FDA-DeviceOsteomed, LLCClass II
OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-06-10FDA-DeviceOsteomed, LLCClass II
OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-06-10FDA-DeviceOsteomed, LLCClass II
OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
2020-06-10FDA-DeviceAmerican Contract SystemsClass II
Sterile Custom Packs to be used in surgical procedures.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
2020-06-10FDA-DeviceAmerican Contract SystemsClass II
Sterile Custom Packs to be used in surgical procedures.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
2020-06-10FDA-DeviceAmerican Contract SystemsClass II
Sterile Custom Packs to be used in surgical procedures.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
2020-06-10FDA-DeviceAmerican Contract SystemsClass II
Sterile Custom Packs to be used in surgical procedures.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
2020-06-10FDA-DeviceAmerican Contract SystemsClass II
Sterile Custom Packs to be used in surgical procedures.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
2020-06-10FDA-DeviceAmerican Contract SystemsClass II
Sterile Custom Packs to be used in surgical procedures.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
2020-06-10FDA-DeviceAmerican Contract SystemsClass II
Sterile Custom Packs to be used in surgical procedures.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
2020-06-10FDA-DeviceAmerican Contract SystemsClass II
Sterile Custom Packs to be used in surgical procedures.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
2020-06-10FDA-DeviceAmerican Contract SystemsClass II
Sterile Custom Packs to be used in surgical procedures.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
2020-06-10FDA-DeviceAmerican Contract SystemsClass II
Sterile Custom Packs to be used in surgical procedures.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
2020-06-10FDA-DeviceAmerican Contract SystemsClass II
Sterile Custom Packs to be used in surgical procedures.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
2020-06-10FDA-DeviceAmerican Contract SystemsClass II
Custom Packs to be used in surgical procedures.
The surgical gowns were manufactured in a facility that is not registered by the FDA.
2020-06-10FDA-DeviceAmerican Contract SystemsClass II
Sterile Custom Packs to be used in surgical procedures.
The surgical gowns were manufactured in a facility that is not registered by the FDA.

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