Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Howmedica Osteonics Corp.
P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110
Medical Devices·4 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Howmedica Osteonics Corp.
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
Medical Devices·0 affected·Dec 1, 2023
High RiskFDA
Philips North America
BrightView X, Gamma Camera, Product Code 882478
Medical Devices·59 affected·Nov 30, 2023
CriticalFDA
Busse Hospital Disposables, Inc.
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Medical Devices·240 affected·Nov 30, 2023
High RiskFDA
Philips North America
BrightView, Gamma Camera System, Product Code 882480.
Medical Devices·359 affected·Nov 30, 2023
High RiskFDA
Philips North America
BrightView XCT, Gamma Camera, Product Code 882482
Medical Devices·135 affected·Nov 30, 2023
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Medical Devices·938 affected·Nov 29, 2023
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis Vibe Hemo
Medical Devices·331 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC E...
Medical Devices·804 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST ...
Medical Devices·144 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR9...
Medical Devices·7,881 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; ...
Medical Devices·3,196 affected·Nov 29, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.
Medical Devices·2,100 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; b) Baby PICC K...
Medical Devices·244 affected·Nov 29, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; ...
Medical Devices·1,020 affected·Nov 29, 2023
High RiskFDA
Micro-x Ltd.
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Medical Devices·18 affected·Nov 28, 2023
High RiskFDA
Mo-vis Bvba
Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuverin...
Medical Devices·129 affected·Nov 28, 2023
High RiskFDA
Atricure, Inc.
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
Medical Devices·35 affected·Nov 28, 2023
High RiskFDA
Icotec Ag
VADER pedicle system, torque wrench, Catalog Number 42-702
Medical Devices·79 affected·Nov 28, 2023
High RiskFDA
Xtant Medical Holdings, Inc
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Medical Devices·6 affected·Nov 28, 2023
High RiskFDA
Medtronic Navigation, Inc.
Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Medical Devices·4,235 affected·Nov 28, 2023
High RiskFDA
Trimed Inc.
Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N...
Medical Devices·270 affected·Nov 28, 2023
High RiskFDA
Cordis Us Corp
MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites.
Medical Devices·50 affected·Nov 28, 2023
High RiskFDA
Atricure, Inc.
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Medical Devices·1 affected·Nov 28, 2023
High RiskFDA
Medtronic Navigation, Inc.
Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
Medical Devices·4,224 affected·Nov 28, 2023
High RiskFDA
Philips North America
(1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PIC iX Hardware, Mod...
Medical Devices·41 affected·Nov 28, 2023
High RiskFDA
Natus Medical Incorporated
EDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx only
Medical Devices·3,336 affected·Nov 28, 2023
High RiskFDA
Natus Medical Incorporated
External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only
Medical Devices·2,686 affected·Nov 28, 2023
High RiskFDA
Acumed Llc
RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used w...
Medical Devices·513 affected·Nov 27, 2023
High RiskFDA
Mirion Technologies (capintec), Inc.
Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perf...
Medical Devices·467 affected·Nov 27, 2023
High RiskFDA
Ortho-clinical Diagnostics, Inc.
QMS Tacrolimus Calibrators, Product code 10015573
Medical Devices·10 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
AcuMatch Hip System, Catalog Number 142-32-27
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f)...
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-...
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Novation Hip System, Catalog Numbers: 134-36-45
Medical Devices·0 affected·Nov 21, 2023
High RiskFDA
Exactech, Inc.
Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
Medical Devices·0 affected·Nov 21, 2023