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.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceRod" 1.5 MRI 90¿ Cryoablation Needle¿
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceEDGE" 2.4¿ 90p¿ Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceSeed" 1.5 Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceSeed" 1.5 90¿ Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceSphere" 1.5 Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceSphere" 1.5 90¿ Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceSphere" 1.5 S 90¿ Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceSphere" 1.5 Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceSphere" 1.5 90¿ Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceRod" 1.5 Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceRod" 1.5 90¿ Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceRod" 1.5 PLUS Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceRod" 1.5 PLUS 90¿ Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceRod" 1.5 i-Thaw" Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceSphere" 1.5 CX 90¿ Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceRod" 1.5 CX 90¿ Cryoablation Needle¿
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIcePearl" 2.1 CX L 90¿ Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIcePearl" 2.1 CX Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIcePearl" 2.1 CX 90¿ Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceFORCE" 2.1 CX L 90¿ Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceFORCE" 2.1 CX Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceBoston Scientific CorporationClass IIIceFORCE" 2.1 CX 90¿ Cryoablation Needle
Complaint trend regarding needle shaft gas leaks.
- 2020-12-30FDA-DeviceHardy DiagnosticsClass IIViral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents
There is a potential for contamination within Viral Transport Media. Use of contaminated Viral Transport Media for the transport of patient specimen may compromise the detection of COVID-19 by the final device used for testing.
- 2020-12-30FDA-DeviceNova Ortho-Med IncClass IIStar 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red)
Walkers within the identified serial range have the potential for the front fork to unscrew itself from the leg. A partially unscrewed fork creates unevenness in the wheelbase, which could cause instability, that if not detected by the user, may result in the front fork falling off the walker.
- 2020-12-30FDA-DeviceCryoLife, Inc.Class IICryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the patch into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for
On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.
- 2020-12-30FDA-DeviceCryoLife, Inc.Class IICryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a
On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.
- 2020-12-30FDA-DeviceConMed CorporationClass IIInfinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system
- 2020-12-30FDA-DeviceConMed CorporationClass IIInfinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
Tips of the Infinity ACL Tibial Elbow and Tip Guides are potentially misaligned laterally which could affect the accuracy of the guide system
- 2020-12-30FDA-DeviceGA HEALTH COMPANY LIMITEDClass IIScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Biopsy Valve, Auxiliary Water Connector Product Code: 345SVVO4
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
- 2020-12-30FDA-DeviceGA HEALTH COMPANY LIMITEDClass IIScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501 Product Code: 345SVVO1
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
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