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Rainbow DC-I-DC Pulse CO-Oximeter Sensor used with the Masimo SET Rad 57 Pulse CoOximeter

FDA Recall
Terminated ·Masimo Corporation·Product code DQA·February 2, 2006

NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM ID; b) 8229707, 7.0MM ID; c) 8229708, 8.0MM ID; d) 8229736, 6MM ID 3PK; e) 8229737, 7MM ID 3 PK; f) 8229738, 8MM ID 3 PK

FDA Recall
Open, Classified ·Medtronic Xomed, Inc.·Product code ETN·November 7, 2023

SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.

FDA Recall
Open, Classified ·Hologic, Inc·Product code MUE·April 8, 2026

Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D

FDA Recall
Open, Classified ·Hologic, Inc.·Product code OTE·January 16, 2023

ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1 Cutting shaping bone including spine and cranium.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code HBE·April 13, 2015

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

FDA Recall
Open, Classified ·Max Mobility LLC·Product code ITI·December 20, 2024

Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

FDA Recall
Open, Classified ·Max Mobility LLC·Product code ITI·August 12, 2025

MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging]. General Hospital Use.

FDA Recall
Terminated ·Owens & Minor Distribution, Inc.·Product code KGX·November 17, 2015

MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.

FDA Recall
Terminated ·Owens & Minor Distribution, Inc.·Product code KGX·November 17, 2015

MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.

FDA Recall
Terminated ·Owens & Minor Distribution, Inc.·Product code KGX·November 17, 2015

GS70 Salus Surgical Table, Product Code 18-070-70

FDA Recall
Open, Classified ·Skytron, LLC·Product code GDC·August 1, 2023

Microsurgical Operating Room Tables;7300BX (18-351-70).

FDA Recall
Open, Classified ·Mizuho America, Inc.·Product code GDC·September 11, 2019

ASC2000 Ambulatory Surgical Table. Model #MTS110003. The device is used to provide complete and flexible positioning for surgical procedures.

FDA Recall
Terminated ·Steris Corp·Product code GDC·April 17, 2009

CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321

FDA Recall
Terminated ·Carolina Liquid Chemistries·Product code DIC·January 16, 2019

Microsurgical Operating Room Tables;7300B (18-350-70);

FDA Recall
Open, Classified ·Mizuho America, Inc.·Product code GDC·September 11, 2019

Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code GDC·June 28, 2024

C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001,

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code GDC·September 20, 2022

Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.

FDA Recall
Terminated ·Lin-Zhi International Inc·Product code DIC·January 11, 2019

Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code DIC·February 14, 2020

Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code GDC·February 25, 2025