FDA Recalls USDA Recalls About

FDA Recalls

Food recalls
Drug recalls
Device recalls

USDA Recalls

All USDA recalls
Poultry recalls
Meat recalls
Egg recalls

About

About us
FDA guides
USDA guides
Data sources
Privacy policy

Data

OpenFDA API
USDA FSIS

© 2026Civic Data · Data sourced from OpenFDA and USDA FSIS · Not affiliated with the U.S. Food and Drug Administration or the U.S. Department of Agriculture · Always verify against official sources before acting

FDA Recalls
›Device Recalls

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 81–100 of 1,000 recalls

Class IITerminated

TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.

Trackx Technology Inc

The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.

October 24, 2022 · DeviceView details →

Class IITerminated

eSuction Small Cavity, Model ET2005

Endo-Therapeutics, Inc.

Improper device regulatory classification

October 24, 2022 · DeviceView details →

Class IITerminated

regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric 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

regard BASIC NEURO, NU00259R, Item Number 800021018; neuro 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

regard RETINAL PACK, EY00935C, Item Number 800730003; EYE 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

regard NEURO PACK, NU00278L, Item Number 800040012; nuero 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

regard BASIC NEURO, NU00259S, Item Number 800021019; neuro 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 ITerminated

Thermo SCIENTIFIC, Sensititre STP6F, 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.

October 20, 2022 · DeviceView details →

Class IITerminated

regard SPINE PACK, NU00260H, Item Number 800022008; 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 ITerminated

Thermo SCIENTIFIC, Sensititre GN7F, 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.

October 20, 2022 · DeviceView details →

Class IITerminated

regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; 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

¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac 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

regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro 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

regard SHOULDER PACK, GS00125V, Item Number 880120022; 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

regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; 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

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.

October 20, 2022 · DeviceView details →

Class ITerminated

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.

October 20, 2022 · DeviceView details →

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 →

Class IITerminated

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.

October 20, 2022 · DeviceView details →

Class IITerminated

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.

October 20, 2022 · DeviceView details →

← PreviousPage 5 of 50Next →