Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 217 of 548
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17)
Howmedica Osteonics Corp.
FDA Devices Moderate May 27, 2020
BARD MYPICC KIT 4F Dual-Lumen, Catalog Number CK000418B
Becton Dickinson & Company
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)
Howmedica Osteonics Corp.
FDA Devices Moderate May 27, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90167, UDI # 10888857108806, Siz…
K2M, Inc
FDA Devices Moderate May 27, 2020
Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, and APYX-…
Bovie Medical Corporation
FDA Devices Moderate May 27, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 10888857108400, Siz…
K2M, Inc
FDA Devices Moderate May 27, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90169, UDI # 10888857108820, Siz…
K2M, Inc
FDA Devices Moderate May 27, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90163, UDI # 10888857108769, Siz…
K2M, Inc
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right, Sterile, Catalog # 504-02-58D-R, UDI (01)07613327012446(17)
Howmedica Osteonics Corp.
FDA Devices Moderate May 27, 2020
BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000025
Becton Dickinson & Company
FDA Devices Moderate May 27, 2020
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90135, UDI # 10888857108486, Siz…
K2M, Inc
CPSC Moderate May 27, 2020
Primark Recalls Kitten Heel Court Shoes Due to High Levels of Chromium; Risk of Skin Irritation
FDA Devices Moderate May 20, 2020
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Microbore Tubing …
BD SWITZERLAND SARL
FDA Devices Moderate May 20, 2020
Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray i…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate May 20, 2020
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microb…
BD SWITZERLAND SARL
FDA Devices Moderate May 20, 2020
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for Drainage…
Covidien Llc
FDA Devices Moderate May 20, 2020
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - Product Usage: is used to g…
Access Scientific LLC
FDA Devices Moderate May 20, 2020
DeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline Flush Syringe, labeled as follows: a. H* Vein Pack Pgybk, 89-62…
DeRoyal Industries Inc
FDA Devices Moderate May 20, 2020
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or …
ICU Medical, Inc.
FDA Devices Moderate May 20, 2020
Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Accelerator a…
Inpeco S.A.
FDA Devices Moderate May 20, 2020
VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate May 20, 2020
iChem¿VELOCITY Urine Chemistry System-
Beckman Coulter Inc.
FDA Devices Moderate May 20, 2020
TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circulatory s…
Cardiac Assist, Inc
FDA Devices Moderate May 20, 2020
Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray im…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate May 20, 2020
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected…
Covidien Llc
FDA Devices Moderate May 20, 2020
da Vinci Xi Surgical System
Intuitive Surgical, Inc.
FDA Devices Moderate May 20, 2020
Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Samp…
Covidien Llc
FDA Devices Moderate May 20, 2020
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit. REF/UDI / 94124/10859821006480 - Product Usage: is used to gai…
Access Scientific LLC
FDA Devices Moderate May 20, 2020
TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulat…
Cardiac Assist, Inc
FDA Devices Moderate May 20, 2020
Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interven…
Philips North America, LLC
FDA Devices Moderate May 20, 2020
Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag…
Genicon, Inc.
FDA Devices Moderate May 20, 2020
Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sam…
Covidien Llc
FDA Devices Moderate May 20, 2020
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr . REF/UDI 80701/10859821006213 - Product Usage: is used to ga…
Access Scientific LLC
FDA Devices Moderate May 20, 2020
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit. REF/UDI / 94115/10859821006251 - Product Usage: is used to gain a…
Access Scientific LLC
FDA Devices Moderate May 20, 2020
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - Product Usage: is …
Access Scientific LLC
FDA Devices Moderate May 20, 2020
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Edwards Lifesciences, LLC
FDA Devices Moderate May 20, 2020
da Vinci X Surgical System
Intuitive Surgical, Inc.
FDA Devices Moderate May 20, 2020
Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A Expandable …
Sunrise Medical (US) LLC
FDA Devices Moderate May 20, 2020
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 8001133-90 slides, UDI Number 10758750004201 - Product Usage: The VITROS Chem…
Ortho-Clinical Diagnostics
FDA Devices Moderate May 20, 2020
Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who hav…
The Magstim Company Limited
FDA Devices Moderate May 20, 2020
PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use…
Argon Medical Devices, Inc
FDA Devices Moderate May 20, 2020
Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects wit…
Edwards Lifesciences, LLC
FDA Devices Moderate May 20, 2020
Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, S…
Ra Medical Systems, Inc.
FDA Devices Moderate May 20, 2020
VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8232-300 slides, UDI Number 10758750004294 - Product Usage: The VITROS Ch…
Ortho-Clinical Diagnostics
FDA Devices Moderate May 20, 2020
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick Kit. REF/UDI / 94114/10859821006220 - Product Usage: is used to gain ac…
Access Scientific LLC
FDA Devices Moderate May 20, 2020
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage …
Covidien Llc
FDA Devices Moderate May 20, 2020
BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Cathet…
Bard Peripheral Vascular Inc
FDA Devices Moderate May 20, 2020
CuattroDR System Software, REF: SWR-00069-MD, UDI: B269SWR00069MD0
Cuattro LLC
FDA Devices Moderate May 20, 2020
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - Product Usage: for Drainage …
Covidien Llc
FDA Devices Moderate May 20, 2020
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 00859821006674 - Product Usage: is used to gain ac…
Access Scientific LLC