FDA Device Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 101–120 of 1,000 recalls

Class IITerminated

regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit

ROi CPS LLC

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

October 20, 2022 · DeviceView details →

Class IITerminated

CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208

CoreLink LLC

Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.

October 20, 2022 · DeviceView details →

Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

FDA Device Recalls

regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit

CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208

regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit

regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit

regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit

regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit

regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kit

regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit

Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST

¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit

regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit

regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit

Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST

Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST

regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit

Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST

regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit

regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit

Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST

regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenience kit