Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 87 of 548
FDA Devices Critical Feb 28, 2024
Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
Windstone Medical Packaging, Inc.
FDA Devices Critical Feb 28, 2024
Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 40…
Cardinal Health 200, LLC
FDA Devices Moderate Feb 28, 2024
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000
W&H DENTALWERK BUERMOOS GMBH
FDA Devices Moderate Feb 28, 2024
OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
IMPULSE DYNAMICS (USA) INC
FDA Devices Moderate Feb 28, 2024
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)-A c…
B. Braun Medical, Inc.
FDA Devices Moderate Feb 28, 2024
Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.
FUJIFILM Healthcare Americas Corporation
FDA Devices Moderate Feb 28, 2024
Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Im…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Critical Feb 28, 2024
Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline, 6 …
Cardinal Health 200, LLC
FDA Devices Moderate Feb 28, 2024
These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal, virucidal, bactericidal, and fungi…
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Feb 28, 2024
The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists …
Canon Medical System, USA, INC.
FDA Devices Critical Feb 28, 2024
Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPI…
Cardinal Health 200, LLC
FDA Devices Critical Feb 28, 2024
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
Windstone Medical Packaging, Inc.
FDA Devices Moderate Feb 28, 2024
ESG PK CUTTING FORCEPS, 5MM, 33CM
Olympus Corporation of the Americas
FDA Devices Critical Feb 21, 2024
GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4…
Wipro GE Healthcare Private Ltd.
FDA Devices Moderate Feb 21, 2024
Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Stryker, Inc.
FDA Devices Moderate Feb 21, 2024
FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic ac…
BioFire Diagnostics, LLC
FDA Devices Moderate Feb 21, 2024
BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
Maquet Medical Systems USA
FDA Devices Moderate Feb 21, 2024
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Pro…
Abiomed, Inc.
FDA Devices Moderate Feb 21, 2024
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
SEDECAL SA
FDA Devices Moderate Feb 21, 2024
Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm
Stryker, Inc.
FDA Devices Moderate Feb 21, 2024
ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150
Philips North America
FDA Devices Moderate Feb 21, 2024
Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid …
Mirion Technologies (Capintec), Inc.
FDA Devices Moderate Feb 21, 2024
The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protei…
Quidel Corporation
FDA Devices Moderate Feb 21, 2024
Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cov…
Olympus Corporation of the Americas
FDA Devices Moderate Feb 21, 2024
ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110
Philips North America
FDA Devices Moderate Feb 21, 2024
Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed …
OriGen Biomedical, Inc.
FDA Devices Moderate Feb 21, 2024
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Zimmer Surgical Inc
FDA Devices Moderate Feb 21, 2024
CombiDiagnost R90 1.1 (709031)
PHILIPS MEDICAL SYSTEMS
FDA Devices Moderate Feb 21, 2024
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
Maquet Medical Systems USA
FDA Devices Critical Feb 21, 2024
GE Healthcare Care Plus Hood Door FRU kit, Part Numbers: 6600-0082-850, 6600-0504-800, 6600-0148-800, and 6600-0970-500
Wipro GE Healthcare Private Ltd.
FDA Devices Critical Feb 21, 2024
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) …
Abiomed, Inc.
FDA Devices Moderate Feb 21, 2024
Samsung Digital Diagnostic Mobile X-ray System, Model GM85.
NeuroLogica Corporation
FDA Devices Critical Feb 21, 2024
GE Healthcare Lullaby Incubator Model Hood Door FRU kit, Part Numbers: M1169767, M1160674, M1187512, M1206646, M1166822
Wipro GE Healthcare Private Ltd.
FDA Devices Moderate Feb 21, 2024
AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler)
Musculoskeletal Transplant Foundation, Inc.
FDA Devices Moderate Feb 21, 2024
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
Microbiologics Inc
CPSC Moderate Feb 15, 2024
BRS and BULin Liquid Fuel Bottles Recalled Due to Risk of Poisoning, Burn, and Flash Fire; Violation of the Children's Gasoline Burn Prevention Safet…
WAOLi, of China
FDA Devices Moderate Feb 14, 2024
ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
Globus Medical, Inc.
FDA Devices Moderate Feb 14, 2024
BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231691 and 231692¿
Becton Dickinson & Co.
FDA Devices Moderate Feb 14, 2024
BD BBL Sensi Disc Azithromycin -15 ¿g, Catalog Number 231682¿used for semi-quantitative in vitro susceptibility testing.
Becton Dickinson & Co.
FDA Devices Moderate Feb 14, 2024
BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿
Becton Dickinson & Co.
FDA Devices Moderate Feb 14, 2024
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
Beckman Coulter, Inc.
FDA Devices Moderate Feb 14, 2024
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseS…
CooperSurgical, Inc.
FDA Devices Moderate Feb 14, 2024
BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231673 and 231674¿
Becton Dickinson & Co.
FDA Devices Moderate Feb 14, 2024
FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)
BioFire Diagnostics, LLC
FDA Devices Moderate Feb 14, 2024
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Olympus Corporation of the Americas
FDA Devices Critical Feb 14, 2024
BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4…
Philips North America
FDA Devices Moderate Feb 14, 2024
PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, R…
Angiodynamics, Inc.
FDA Devices Moderate Feb 14, 2024
Sensi Disc Amoxicillin with Clavulanic Acid 20/10 ¿g, Catalog No. 231628 and 231629.¿ These discs are used for semi-quantitative in vitro suscepti…
Becton Dickinson & Co.
FDA Devices Moderate Feb 14, 2024
Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the ri…
Olympus Corporation of the Americas
FDA Devices Moderate Feb 14, 2024
Flow-c Anesthesia System, model 6887700
Getinge Usa Sales Inc