Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Landauer
QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) 18135-SET; radiation monitoring dosimeter used with the m...
Medical Devices·10,741 affected·Jul 12, 2023
High RiskFDA
Medicrea International
GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿...
Medical Devices·0 affected·Jul 12, 2023
High RiskFDA
Landauer
nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d) 03061-SMO; radiation monitoring dosimeter used with t...
Medical Devices·13,950 affected·Jul 12, 2023
High RiskFDA
Medicrea International
IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B2017196...
Medical Devices·0 affected·Jul 12, 2023
High RiskFDA
Abbott Diabetes Care, Inc.
FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with FreeStyle Libre 2 System
Medical Devices·1,722,645 affected·Jul 12, 2023
High RiskFDA
Landauer
nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR readers
Medical Devices·16,820 affected·Jul 12, 2023
High RiskFDA
Landauer
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; radiation monitoring dosimeter used with...
Medical Devices·973 affected·Jul 12, 2023
High RiskFDA
Landauer
nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO; d) 03062-SMO; radiation monitoring dosimeter used with t...
Medical Devices·0 affected·Jul 12, 2023
High RiskFDA
Advance Medical Designs, Inc.
ASG-001; Ultrasound gel
Medical Devices·0 affected·Jul 7, 2023
High RiskFDA
Advance Medical Designs, Inc.
50-GEL20; Ultrasound gel
Medical Devices·13,750 affected·Jul 7, 2023
High RiskFDA
Karl Storz Endoscopy
Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only
Medical Devices·218 affected·Jul 7, 2023
High RiskFDA
Advance Medical Designs, Inc.
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
Medical Devices·26,900 affected·Jul 7, 2023
High RiskFDA
Advance Medical Designs, Inc.
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-...
Medical Devices·117,875 affected·Jul 7, 2023
High RiskFDA
Alphatec Spine, Inc.
LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and ...
Medical Devices·29 affected·Jul 7, 2023
High RiskFDA
Advance Medical Designs, Inc.
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 2...
Medical Devices·460 affected·Jul 7, 2023
High RiskFDA
Aquila Corporation
APK2 Pressure-Sensing Wheelchair Cushions
Medical Devices·117 affected·Jul 6, 2023
High RiskFDA
Medtronic Neuromodulation
Medtronic InterStim Ground Pad REF 041826
Medical Devices·360 affected·Jul 6, 2023
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defect...
Medical Devices·24 affected·Jul 3, 2023
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defect...
Medical Devices·24 affected·Jul 3, 2023
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects ...
Medical Devices·14 affected·Jul 3, 2023
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defect...
Medical Devices·24 affected·Jul 3, 2023
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 15 - Indicated for patients with Mobility-limiting diseases, fractures or defect...
Medical Devices·24 affected·Jul 3, 2023
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 16 - Indicated for patients with Mobility-limiting diseases, fractures or defect...
Medical Devices·24 affected·Jul 3, 2023
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 19-Indicated for patients with Mobility-limiting diseases, fractures or defects ...
Medical Devices·24 affected·Jul 3, 2023
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 21 - Indicated for patients with Mobility-limiting diseases, fractures or defect...
Medical Devices·24 affected·Jul 3, 2023
High RiskFDA
Cardiac Assist, Inc
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000...
Medical Devices·2 affected·Jun 30, 2023
High RiskFDA
Philips Medical Systems Nederland B.v.
Wireless Foot Switch distributed with Philips Allura Xper and Azurion Interventional Fluoroscopic X-Ray Systems
Medical Devices·1,865 affected·Jun 30, 2023
High RiskFDA
Alcon Research, Ltd.
Centurion FMS Pak
Medical Devices·87,839 affected·Jun 28, 2023
High RiskFDA
Stryker Corporation
stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery
Medical Devices·464 affected·Jun 28, 2023
High RiskFDA
Alcon Research, Ltd.
Legion FMS Pak
Medical Devices·2,628 affected·Jun 28, 2023
High RiskFDA
Stryker Corporation
stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery
Medical Devices·1,489 affected·Jun 28, 2023
High RiskFDA
Alcon Research, Ltd.
Constellation Procedure Pak
Medical Devices·10,580 affected·Jun 28, 2023
High RiskFDA
Alcon Research, Ltd.
Infinity FMS Pak
Medical Devices·51,054 affected·Jun 28, 2023
High RiskFDA
Alcon Research, Ltd.
Alcon Custom Pak
Medical Devices·1,682,351 affected·Jun 28, 2023
High RiskFDA
Zimmer, Inc.
Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation an...
Medical Devices·75 affected·Jun 27, 2023
High RiskFDA
Digisonics, Inc
Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software
Medical Devices·32 affected·Jun 26, 2023
High RiskFDA
Paragon Vision Sciences, Inc
ISee Ortho-K Lens
Medical Devices·83,542 affected·Jun 26, 2023
High RiskFDA
Paragon Vision Sciences, Inc
Fargo Ortho-K Lens
Medical Devices·18,820 affected·Jun 26, 2023
High RiskFDA
Microtek Medical Inc.
Equipment and table drapes: (1) Ecolab Banded Bag with Rubberband and Tape, 91 cm x 51 cm (36 in x 20 in), Model 63620RT, pkgd. 25/cas...
Medical Devices·9,293 affected·Jun 23, 2023
High RiskFDA
Scholly Fiberoptic Gmbh
UroLift Visual Obturator, 20Ch-The visual obturator is used with the UroLift¿ system. Instrument for insertion of a cystoscope shaft into...
Medical Devices·98 affected·Jun 23, 2023
High RiskFDA
Cytrellis Biosystems, Inc.
ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles ...
Medical Devices·127 affected·Jun 23, 2023
High RiskFDA
Scican Ltd.
STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by mea...
Medical Devices·19 affected·Jun 22, 2023
High RiskFDA
Wilson-cook Medical Inc.
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for e...
Medical Devices·402 affected·Jun 22, 2023
High RiskFDA
Creganna Medical Devices
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Medical Devices·194 affected·Jun 22, 2023
High RiskFDA
Wilson-cook Medical Inc.
Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-2X4 G48277; Fusion Lithotripsy Extraction Baskets are intended to be used for ...
Medical Devices·393 affected·Jun 22, 2023
High RiskFDA
Medtronic Neuromodulation
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Medical Devices·2 affected·Jun 21, 2023
High RiskFDA
Beckman Coulter, Inc.
Ringed DxI Reaction Vessels (RVs)
Medical Devices·213 affected·Jun 20, 2023
High RiskFDA
Baxter Healthcare Corporation
GEM FLOW COUPLER Monitor, PN 5156-00000-011
Medical Devices·122 affected·Jun 19, 2023