FDA Device Recalls

regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit

ROi CPS LLC

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

Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST

Remel Inc

An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.

Class IITerminated

regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; 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 →

regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit

ROi CPS LLC

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

regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit

ROi CPS LLC

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

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.

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.

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

ROi CPS LLC

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

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

ROi CPS LLC

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

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

ROi CPS LLC

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

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

ROi CPS LLC

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

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

ROi CPS LLC

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

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

ROi CPS LLC

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

Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST

Remel Inc

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

ROi CPS LLC

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

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

ROi CPS LLC

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

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

ROi CPS LLC

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

Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST

Remel Inc

Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST

Remel Inc

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

ROi CPS LLC

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