Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
CriticalFDA
Endologix
ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Proximal Accessory, Infrarenal Model #/R...
Medical Devices·56,503 affected·Jul 31, 2018
High RiskFDA
Oridion Medical 1987 Ltd.
CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658
Medical Devices·144 affected·Jul 31, 2018
High RiskFDA
Oridion Medical 1987 Ltd.
Capnostream20 (INTL) M, CS08654
Medical Devices·56 affected·Jul 31, 2018
High RiskFDA
Oridion Medical 1987 Ltd.
Capnostream20 (INTL) N REFURBISHED, CS78652
Medical Devices·5 affected·Jul 31, 2018
High RiskFDA
Oridion Medical 1987 Ltd.
Capnostream20 M NICU (CPM), CS08654RN
Medical Devices·262 affected·Jul 31, 2018
High RiskFDA
Oridion Medical 1987 Ltd.
CAPNOSTREAM 20P (INTL) N - ROHS, Part Number CS08652-03
Medical Devices·264 affected·Jul 31, 2018
High RiskFDA
Oridion Medical 1987 Ltd.
CAPNOSTREAM 20 (INTL) N, Part Number CS08652
Medical Devices·245 affected·Jul 31, 2018
High RiskFDA
Oridion Medical 1987 Ltd.
CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01
Medical Devices·113 affected·Jul 31, 2018
High RiskFDA
Oridion Medical 1987 Ltd.
Capnostream20 (US) M, Part Number CS08653
Medical Devices·769 affected·Jul 31, 2018
High RiskFDA
Oridion Medical 1987 Ltd.
CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Medical Devices·1,798 affected·Jul 31, 2018
High RiskFDA
Oridion Medical 1987 Ltd.
CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03
Medical Devices·56 affected·Jul 31, 2018
High RiskFDA
Oridion Medical 1987 Ltd.
Capnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660
Medical Devices·8 affected·Jul 31, 2018
High RiskFDA
Oridion Medical 1987 Ltd.
Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659
Medical Devices·22 affected·Jul 31, 2018
High RiskFDA
Oridion Medical 1987 Ltd.
Capnostream20 N CYVITAL, CS08799
Medical Devices·20 affected·Jul 31, 2018
High RiskFDA
Oridion Medical 1987 Ltd.
CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01
Medical Devices·113 affected·Jul 31, 2018
High RiskFDA
Oridion Medical 1987 Ltd.
Capnostream20 (US)M REFURBISHED, Part Number CS78653
Medical Devices·43 affected·Jul 31, 2018
High RiskFDA
Zimmer Biomet Spine Inc.
Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation is indicated for ...
Medical Devices·16,429 affected·Jul 30, 2018
High RiskFDA
Zimmer Biomet Spine Inc.
Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletal...
Medical Devices·16,429 affected·Jul 30, 2018
High RiskFDA
Zimmer Biomet Spine Inc.
Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skelet...
Medical Devices·16,429 affected·Jul 30, 2018
High RiskFDA
Civco Medical Instruments Co. Inc.
CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
Medical Devices·3 affected·Jul 30, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
Medical Devices·429 affected·Jul 29, 2018
High RiskFDA
Stryker Gmbh
Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
Medical Devices·233 affected·Jul 26, 2018
High RiskFDA
Covidien Llc
Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): ...
Medical Devices·46,961 affected·Jul 26, 2018
High RiskFDA
Ge Medical Systems China Co., Ltd.
GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
Medical Devices·310 affected·Jul 24, 2018
High RiskFDA
K2m, Inc
YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16...
Medical Devices·364 affected·Jul 24, 2018
High RiskFDA
Qiagen Sciences Llc
EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isol...
Medical Devices·298 affected·Jul 23, 2018
High RiskFDA
Johnson & Johnson Vision Care, Inc.
Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25 Power. Master Lot, containing 12 split lots, repacka...
Medical Devices·195,660 affected·Jul 23, 2018
High RiskFDA
Zimmer Biomet, Inc.
Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629
Medical Devices·52 affected·Jul 20, 2018
High RiskFDA
Zimmer Biomet, Inc.
Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612
Medical Devices·52 affected·Jul 20, 2018
High RiskFDA
Beaver Visitec
Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intende...
Medical Devices·800 affected·Jul 19, 2018
High RiskFDA
Depuy Orthopaedics, Inc.
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
Medical Devices·1 affected·Jul 18, 2018
High RiskFDA
Abbott Laboratories, Inc
Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
Medical Devices·30 affected·Jul 18, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 440 mm, Item Number: 814309440
Medical Devices·5,947 affected·Jul 17, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 125¿ 9 mm x 460 mm, Item Number: 814309460
Medical Devices·5,947 affected·Jul 17, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 460 mm, Item Number: 814513460
Medical Devices·5,947 affected·Jul 17, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 360 mm, Item Number: 814411360
Medical Devices·5,947 affected·Jul 17, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 280 mm, Item Number: 814511280
Medical Devices·5,947 affected·Jul 17, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 360 mm, Item Number: 814611360
Medical Devices·5,947 affected·Jul 17, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 400 mm, Item Number: 814515400
Medical Devices·5,947 affected·Jul 17, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 400 mm, Item Number: 814611400
Medical Devices·5,947 affected·Jul 17, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 360 mm, Item Number: 814509360
Medical Devices·5,947 affected·Jul 17, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 300 mm, Item Number: 814409300
Medical Devices·5,947 affected·Jul 17, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 380 mm, Item Number: 814509380
Medical Devices·5,947 affected·Jul 17, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 280 mm, Item Number: 814613280
Medical Devices·5,947 affected·Jul 17, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Right 130¿ 15 mm x 360 mm, Item Number: 814515360
Medical Devices·5,947 affected·Jul 17, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm, Item Number: 814309180
Medical Devices·5,947 affected·Jul 17, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 360 mm, Item Number: 814409360
Medical Devices·5,947 affected·Jul 17, 2018
High RiskFDA
Zimmer Biomet, Inc.
Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 260 mm, Item Number: 814413260
Medical Devices·5,947 affected·Jul 17, 2018