Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 52 of 548
FDA Devices Moderate Nov 13, 2024
SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for radiographic and fluoroscopic examinations, including general radi…
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
FDA Devices Moderate Nov 13, 2024
GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, GDZH-JINWAN-Centricity 2) 2089507-093, 10510-3-Centricit…
GE Healthcare
FDA Devices Moderate Nov 13, 2024
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PE…
Canon Medical System, USA, INC.
FDA Devices Critical Nov 13, 2024
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, D…
Elekta Instrument AB
FDA Devices Moderate Nov 13, 2024
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Siemens Healthcare Diagnostics Inc
FDA Devices Moderate Nov 6, 2024
Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
Olympus Corporation of the Americas
FDA Devices Moderate Nov 6, 2024
SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of tissue, inclu…
Integra LifeSciences Corp.
FDA Devices Low Nov 6, 2024
17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in se…
DRG International, Inc.
FDA Devices Moderate Nov 6, 2024
Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091
Abbott Molecular, Inc.
FDA Devices Critical Nov 6, 2024
GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844…
DATEX--OHMEDA, INC.
FDA Devices Critical Nov 6, 2024
VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
Maquet Cardiovascular, LLC
FDA Devices Moderate Nov 6, 2024
Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN…
Covidien LP
FDA Devices Moderate Nov 6, 2024
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Nihon Kohden America Inc
FDA Devices Low Nov 6, 2024
Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of …
Trackx Technology Inc
FDA Devices Moderate Nov 6, 2024
SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips are indicated for the use in protection of tissue, includi…
Integra LifeSciences Corp.
FDA Devices Moderate Nov 6, 2024
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Nihon Kohden America Inc
FDA Devices Moderate Nov 6, 2024
AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Num…
King Systems Corp. dba Ambu, Inc.
FDA Devices Moderate Nov 6, 2024
SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in protection of tissue, includi…
Integra LifeSciences Corp.
FDA Devices Moderate Nov 6, 2024
SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in protection of tissue, includin…
Integra LifeSciences Corp.
FDA Devices Critical Nov 6, 2024
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Syst…
Smiths Medical ASD Inc.
FDA Devices Moderate Nov 6, 2024
KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421
King Systems Corp. dba Ambu, Inc.
FDA Devices Critical Nov 6, 2024
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
Percussionaire Corporation
FDA Devices Moderate Nov 6, 2024
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody…
Beckman Coulter, Inc.
FDA Devices Moderate Nov 6, 2024
a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100273, P79…
Baxter Healthcare Corporation
FDA Devices Moderate Nov 6, 2024
SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical strips are indicated for the use in protection of tissue, i…
Integra LifeSciences Corp.
FDA Devices Moderate Nov 6, 2024
Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confir…
Princeton Biomeditech Corp
FDA Devices Moderate Nov 6, 2024
Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;
Abbott Molecular, Inc.
FDA Devices Moderate Nov 6, 2024
SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the use in protection of tissue, inc…
Integra LifeSciences Corp.
FDA Devices Moderate Nov 6, 2024
SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the use in protection of tissue, inc…
Integra LifeSciences Corp.
FDA Devices Moderate Nov 6, 2024
AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
Accriva Diagnostics, Inc.
FDA Devices Moderate Nov 6, 2024
SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicated for the use in protection of tissue, including…
Integra LifeSciences Corp.
FDA Devices Moderate Nov 6, 2024
SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips are indicated for the use in protection of tissue, including …
Integra LifeSciences Corp.
FDA Devices Moderate Nov 6, 2024
Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr…
Ambu Inc.
FDA Devices Moderate Nov 6, 2024
SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use in protection of tissue, inc…
Integra LifeSciences Corp.
FDA Devices Moderate Nov 6, 2024
SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in protection of tissue, including …
Integra LifeSciences Corp.
FDA Devices Moderate Nov 6, 2024
SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including br…
Integra LifeSciences Corp.
FDA Devices Moderate Nov 6, 2024
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, …
Pro-Dex Inc
FDA Devices Moderate Nov 6, 2024
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, …
ImaCor Inc.
FDA Devices Moderate Nov 6, 2024
SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in protection of tissue, including br…
Integra LifeSciences Corp.
FDA Devices Moderate Nov 6, 2024
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
Remel, Inc
FDA Devices Moderate Nov 6, 2024
KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Numb…
King Systems Corp. dba Ambu, Inc.
FDA Devices Moderate Nov 6, 2024
SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use in protection of tissue, inclu…
Integra LifeSciences Corp.
FDA Devices Moderate Nov 6, 2024
SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in protection of tissue, including…
Integra LifeSciences Corp.
FDA Devices Moderate Nov 6, 2024
KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number:…
King Systems Corp. dba Ambu, Inc.
FDA Devices Moderate Nov 6, 2024
smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAIN…
Smith & Nephew Inc
FDA Devices Moderate Nov 6, 2024
smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, m…
Smith & Nephew Inc
FDA Devices Moderate Nov 6, 2024
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
Smith & Nephew Inc
FDA Devices Moderate Nov 6, 2024
SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use in protection of tissue, inclu…
Integra LifeSciences Corp.
FDA Devices Moderate Nov 6, 2024
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Olympus Corporation of the Americas
FDA Devices Moderate Nov 6, 2024
SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in protection of tissue, includin…
Integra LifeSciences Corp.