Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Philips North America Llc
Ingenia Elition X, Magnetic Resonance System.
Medical Devices·448 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Enterprise 1.5T, Magnetic Resonance System.
Medical Devices·33 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
MR 7700, Magnetic Resonance System.
Medical Devices·26 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
GYROSCAN T5, Magnetic Resonance System.
Medical Devices·7 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera Achieva 1.5T Pulsar, Magnetic Resonance System.
Medical Devices·24 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Achieva 3.0TX for PET, Magnetic Resonance System.
Medical Devices·1 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera CV, Magnetic Resonance System.
Medical Devices·8 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Achieva 1.5T Conversion, Magnetic Resonance System.
Medical Devices·115 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera 1.5T R11, Magnetic Resonance System.
Medical Devices·25 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Achieva 1.5T Initial, Magnetic Resonance System.
Medical Devices·69 affected·Mar 12, 2024
High RiskFDA
Philips North America Llc
Intera 1.0T Power/Pulsar, Magnetic Resonance System.
Medical Devices·19 affected·Mar 12, 2024
High RiskFDA
Advanced Instruments, Llc
OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of se...
Medical Devices·58 affected·Mar 11, 2024
High RiskFDA
Conformis, Inc.
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Medical Devices·3 affected·Mar 11, 2024
High RiskFDA
Baxter Healthcare Corporation
HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for hip surgery
Medical Devices·80 affected·Mar 11, 2024
CriticalFDA
Route 92 Medical Inc
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovascul...
Medical Devices·117 affected·Mar 8, 2024
CriticalFDA
Route 92 Medical Inc
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into ...
Medical Devices·750 affected·Mar 8, 2024
CriticalFDA
Route 92 Medical Inc
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neu...
Medical Devices·10 affected·Mar 8, 2024
CriticalFDA
Route 92 Medical Inc
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasc...
Medical Devices·19 affected·Mar 8, 2024
CriticalFDA
Fresenius Kabi Usa, Llc
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Medical Devices·17 affected·Mar 7, 2024
High RiskFDA
Innomed, Inc.
INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup
Medical Devices·41 affected·Mar 7, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Ite...
Medical Devices·39 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-0...
Medical Devices·985 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
Medical Devices·447 affected·Mar 6, 2024
CriticalFDA
Outset Medical, Inc.
Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001
Medical Devices·919 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoul...
Medical Devices·591 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
Medical Devices·2,806 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, ...
Medical Devices·12,643 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, ...
Medical Devices·4,007 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Nu...
Medical Devices·6,840 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium...
Medical Devices·6,678 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13,...
Medical Devices·7,213 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium...
Medical Devices·2,008 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arth...
Medical Devices·11,863 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item...
Medical Devices·35 affected·Mar 6, 2024
High RiskFDA
Microbiologics Inc
KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b, a) REF 0209P and b) REF 0209K, Quality control kit for culture media
Medical Devices·19 affected·Mar 6, 2024
High RiskFDA
Exactech, Inc.
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, ...
Medical Devices·3,436 affected·Mar 6, 2024
High RiskFDA
Wright Medical Technology, Inc.
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
Medical Devices·47 affected·Mar 6, 2024
High RiskFDA
Unomedical A/s
Neria Soft Infusion Set, Product Code 507302, intravascular administration set
Medical Devices·10,770 affected·Mar 5, 2024
High RiskFDA
Baxter Healthcare Corporation
Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of...
Medical Devices·232 affected·Mar 5, 2024
High RiskFDA
Randox Laboratories Ltd.
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clin...
Medical Devices·80,366 affected·Mar 5, 2024
High RiskFDA
Quidel Corporation
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
Medical Devices·31,140 affected·Mar 5, 2024
High RiskFDA
Ion Beam Applications S.a.
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Medical Devices·8 affected·Mar 4, 2024
RecallFDA
Avanos Medical, Inc.
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a.0.5mL Oral Syringe Orange NonSterile, Product C...
Medical Devices·14,102 affected·Mar 4, 2024
RecallFDA
Avanos Medical, Inc.
NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descriptions: a. 0.5mL Oral Syringe Amber NonSterile, Product C...
Medical Devices·37,476 affected·Mar 4, 2024
High RiskFDA
X-nav Technologies, Llc
X-Guide Handpiece Adaptor Sleeve 3, Model P010727
Medical Devices·154 affected·Mar 4, 2024
CriticalFDA
Alere San Diego, Inc.
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Medical Devices·559 affected·Mar 1, 2024
High RiskFDA
Pacific Lasertech, Llc
25-LHP-928, HeNe Laser System, 25 mW
Medical Devices·4 affected·Mar 1, 2024
CriticalFDA
Sleepnet Corporation
Mojo 2 Full Face AAV Non Vented Mask, All Sizes
Medical Devices·1,268 affected·Mar 1, 2024