Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 146 of 548
FDA Devices Moderate Aug 3, 2022
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Aug 3, 2022
Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS…
MEDLINE INDUSTRIES, LP - SPT
FDA Devices Moderate Aug 3, 2022
REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
Abbott Laboratories
FDA Devices Moderate Aug 3, 2022
HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
Paragon 28, Inc.
FDA Devices Moderate Aug 3, 2022
REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
Abbott Laboratories
FDA Devices Moderate Aug 3, 2022
Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot cod…
MEDLINE INDUSTRIES, LP - SPT
FDA Devices Moderate Aug 3, 2022
REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
Abbott Laboratories
FDA Devices Moderate Aug 3, 2022
nordicBrainEX, software versions 2.21 through 2.3.10
NordicNeuroLab AS
FDA Devices Moderate Aug 3, 2022
Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A, b. DYNDP11…
MEDLINE INDUSTRIES, LP - SPT
FDA Devices Moderate Aug 3, 2022
Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003
Intuitive Surgical, Inc.
FDA Devices Moderate Aug 3, 2022
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Aug 3, 2022
X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
Davol, Inc.
FDA Devices Moderate Aug 3, 2022
Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE GENERIC,…
MEDLINE INDUSTRIES, LP - SPT
FDA Devices Moderate Aug 3, 2022
MEDLINE INDUSTRIES, LP - SPT
CPSC Moderate Jul 28, 2022
Black Diamond Equipment Recalls PIEPS and Black Diamond Avalanche Transceivers Due to Risk of Loss of Emergency Communications
CPSC Moderate Jul 28, 2022
Ocean Technology Systems Recalls Underwater Communication Devices Due to Fire Hazard
Undersea Systems International Inc., dba Ocean Technology Systems, of Santa Ana, California
FDA Drug Moderate Jul 27, 2022
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled Syringes per carton,…
Nephron Sterile Compounding Center LLC
FDA Drug Moderate Jul 27, 2022
Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Car…
Nephron Sterile Compounding Center LLC
FDA Devices Moderate Jul 27, 2022
BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
Becton Dickinson & Company
FDA Devices Moderate Jul 27, 2022
AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.
Aesculap Implant Systems LLC
FDA Devices Moderate Jul 27, 2022
SIGNA Premier magnetic resonance scanner, model 5748519.
GE Healthcare, LLC
FDA Devices Moderate Jul 27, 2022
SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the numb…
Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jul 27, 2022
ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: …
DePuy Orthopaedics, Inc.
FDA Devices Moderate Jul 27, 2022
BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)
Becton Dickinson & Company
FDA Devices Low Jul 27, 2022
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
Randox Laboratories Ltd.
FDA Devices Moderate Jul 27, 2022
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Aesculap Implant Systems LLC
FDA Devices Moderate Jul 27, 2022
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, …
Siemens Medical Solutions USA, Inc
FDA Devices Low Jul 27, 2022
NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 …
Synapse Biomedical Inc
FDA Devices Moderate Jul 27, 2022
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Aesculap Implant Systems LLC
FDA Devices Moderate Jul 27, 2022
Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)
Becton Dickinson & Company
FDA Devices Moderate Jul 27, 2022
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
LumiraDx
FDA Devices Critical Jul 27, 2022
GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
GE Healthcare, LLC
FDA Devices Moderate Jul 27, 2022
(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #7142016…
Smith & Nephew, Inc.
FDA Devices Low Jul 27, 2022
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD
Randox Laboratories Ltd.
FDA Devices Moderate Jul 27, 2022
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
CooperSurgical, Inc.
FDA Devices Moderate Jul 27, 2022
Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.
Baxter Healthcare Corporation
FDA Devices Moderate Jul 27, 2022
Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.
Baxter Healthcare Corporation
FDA Devices Moderate Jul 27, 2022
Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391…
Ambu Inc.
FDA Devices Moderate Jul 27, 2022
BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)
Becton Dickinson & Company
FDA Devices Moderate Jul 27, 2022
AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery.
Aesculap Implant Systems LLC
FDA Devices Moderate Jul 27, 2022
RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
Aesculap Implant Systems LLC
FDA Devices Moderate Jul 27, 2022
BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)
Becton Dickinson & Company
FDA Devices Low Jul 27, 2022
Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human s…
R & D Systems, Inc.
FDA Devices Moderate Jul 27, 2022
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
ROi CPS LLC
FDA Devices Moderate Jul 27, 2022
Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)
Becton Dickinson & Company
FDA Devices Moderate Jul 27, 2022
AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.
Aesculap Implant Systems LLC
FDA Devices Moderate Jul 27, 2022
AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.
Aesculap Implant Systems LLC
FDA Devices Moderate Jul 27, 2022
Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032)…
Stryker Instruments Div. of Stryker Corporation
FDA Devices Moderate Jul 27, 2022
BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)
Becton Dickinson & Company
FDA Devices Moderate Jul 27, 2022
Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04.
Baxter Healthcare Corporation