Civic Data
FDA RecallsAbout

FDA Recalls

  • Food recalls
  • Drug recalls
  • Device recalls

Browse

  • All recalls

About

  • About us
  • Guides
  • Data sources
  • Privacy policy

Data

  • OpenFDA API

© 2026Civic Data · Data sourced from OpenFDA, updated weekly · Not affiliated with the U.S. Food and Drug Administration · Always verify against official FDA sources before acting

  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 281–300 of 1,000 recalls

Class IIITerminated

Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499

Hardy Diagnostics

Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box labeling contains an expiration date of 2021-11-10 instead of the correct expiration date of 2020-11-10

October 6, 2020 · DeviceView details →
Class IIITerminated

XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label: Ref: X098-0106-STR DI Number: M697X0980106STR1 Mat.: CP Ti Grade 3, Ref: X098-0107-STR DI Number: M697X0980107STR1 Mat.: CP Ti Grade 4, Ref: X098-0108-STR DI Number: M697X0980108STR1 Mat.: CP Ti Grade 5, Ref: X098-0109-STR DI Number: M697X0980109STR1 Mat.: CP Ti Grade 6, Ref: X098-0110-STR DI Number: M697X0980110STR1 Mat.: CP Ti Grade 7, Ref: X098-0111-STR DI Number: M697X0980111STR1 Mat.: CP Ti Grade 8, Ref: X098-0112-STR DI Number: M697X0980112STR1 Mat.: CP Ti Grade 9, Ref: X098-0205-STR DI Number: M697X0980205STR1 Mat.: CP Ti Grade 10, Ref: X098-0206-STR DI Number: M697X0980206STR1 Mat.: CP Ti Grade 11, Ref: X098-0207-STR DI Number: M697X0980207STR1 Mat.: CP Ti Grade 12, Ref: X098-0208-STR DI Number: M697X0980208STR1 Mat.: CP Ti Grade 13, Ref: X098-0209-STR DI Number: M697X0980209STR1 Mat.: CP Ti Grade 14, Ref: X098-0210-STR DI Number: M697X0980210STR1 Mat.: CP Ti Grade 15, Ref: X098-0211-STR DI Number: M697X0980211STR1 Mat.: CP Ti Grade 16, Ref: X098-0212-STR DI Number: M697X0980212STR1 Mat.: CP Ti Grade 17, Ref: X098-0305-STR DI Number: M697X0980305STR1 Mat.: CP Ti Grade 18, Ref: X098-0306-STR DI Number: M697X0980306STR1 Mat.: CP Ti Grade 19, Ref: X098-0307-STR DI Number: M697X0980307STR1 Mat.: CP Ti Grade 20, Ref: X098-0308-STR DI Number: M697X0980308STR1 Mat.: CP Ti Grade 21, Ref: X098-0309-STR DI Number: M697X0980309STR1 Mat.: CP Ti Grade 22, Ref: X098-0310-STR DI Number: M697X0980310STR1 Mat.: CP Ti Grade 23, Ref: X098-0311-STR DI Number: M697X0980311STR1 Mat.: CP Ti Grade 24, Ref: X098-0312-STR DI Number: M697X0980312STR1 Mat.: CP Ti Grade 25

XTANT Medical

Cervical Implants contain a label that incorrectly identifies the grade of titanium used.

September 30, 2020 · DeviceView details →
Class IIITerminated

AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260). For cochlear implant.

Advanced Bionics, LLC

Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

September 26, 2020 · DeviceView details →
Class IIITerminated

AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260) for cochlear implant.

Advanced Bionics, LLC

Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

September 26, 2020 · DeviceView details →
Class IIITerminated

END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495.394 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Synthes (USA) Products LLC

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

September 21, 2020 · DeviceView details →
Class IIITerminated

END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Synthes (USA) Products LLC

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

September 21, 2020 · DeviceView details →
Class IIITerminated

SYNMESH¿ 22MM X 28MM 88MM HEIGHT (TI) Product Number: 495.379 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Synthes (USA) Products LLC

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

September 21, 2020 · DeviceView details →
Class IIITerminated

STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Synthes (USA) Products LLC

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

September 21, 2020 · DeviceView details →
Class IIITerminated

END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Synthes (USA) Products LLC

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

September 21, 2020 · DeviceView details →
Class IIITerminated

3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Synthes (USA) Products LLC

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

September 21, 2020 · DeviceView details →
Class IIITerminated

SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Synthes (USA) Products LLC

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

September 21, 2020 · DeviceView details →
Class IIITerminated

SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Synthes (USA) Products LLC

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

September 21, 2020 · DeviceView details →
Class IIITerminated

END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Synthes (USA) Products LLC

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

September 21, 2020 · DeviceView details →
Class IIITerminated

SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Synthes (USA) Products LLC

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

September 21, 2020 · DeviceView details →
Class IIITerminated

END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Synthes (USA) Products LLC

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

September 21, 2020 · DeviceView details →
Class IIITerminated

END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Synthes (USA) Products LLC

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

September 21, 2020 · DeviceView details →
Class IIITerminated

END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Synthes (USA) Products LLC

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

September 21, 2020 · DeviceView details →
Class IIITerminated

STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Synthes (USA) Products LLC

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

September 21, 2020 · DeviceView details →
Class IIITerminated

DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Synthes (USA) Products LLC

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

September 21, 2020 · DeviceView details →
Class IIITerminated

MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

Invivo Corporation

The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress.

September 14, 2020 · DeviceView details →
← PreviousPage 15 of 50Next →