Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Roi Cps Llc
regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit
Medical Devices·90 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit
Medical Devices·302 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit
Medical Devices·54 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kit
Medical Devices·326 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit
Medical Devices·38 affected·Oct 20, 2022
CriticalFDA
Remel Inc
Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
Medical Devices·2,471 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit
Medical Devices·456 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit
Medical Devices·738 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit
Medical Devices·780 affected·Oct 20, 2022
CriticalFDA
Remel Inc
Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
Medical Devices·588 affected·Oct 20, 2022
CriticalFDA
Remel Inc
Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST
Medical Devices·70 affected·Oct 20, 2022
High RiskFDA
Roi Cps Llc
regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit
Medical Devices·30 affected·Oct 20, 2022
High RiskFDA
Coopersurgical, Inc.
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
Medical Devices·220,500 affected·Oct 20, 2022
High RiskFDA
Baxter Healthcare Corporation
Hill-Rom Progressa Bed System
Medical Devices·248 affected·Oct 18, 2022
High RiskFDA
Accelerate Diagnostics Inc
Accelerate PhenoTest BC kit REF 10101018
Medical Devices·200 affected·Oct 17, 2022
High RiskFDA
Visionsense, Ltd.
VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number: 175-0012
Medical Devices·34 affected·Oct 17, 2022
High RiskFDA
Getinge Usa Sales Inc
Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
Medical Devices·5 affected·Oct 14, 2022
High RiskFDA
Sonendo Inc
GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Medical Devices·15 affected·Oct 14, 2022
High RiskFDA
Sonendo Inc
GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
Medical Devices·16 affected·Oct 14, 2022
High RiskFDA
Becton Dickinson & Co.
BD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the rapid identification and susceptibility of most aerobic and facultativ...
Medical Devices·13,900 affected·Oct 13, 2022
High RiskFDA
Boston Scientific Corporation
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Medical Devices·16 affected·Oct 13, 2022
High RiskFDA
Medical Action Industries, Inc. 306
Medical Action Industries Inc. Port Access Kit, REF #76511B (on case label), sterile; and Medical Action Industries Inc. IV Start Kit, R...
Medical Devices·24 affected·Oct 12, 2022
High RiskFDA
Novapproach Spine Llc
OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody Syst...
Medical Devices·6 affected·Oct 12, 2022
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP...
Medical Devices·422 affected·Oct 10, 2022
High RiskFDA
Intuitive Surgical, Inc.
INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray...
Medical Devices·160 affected·Oct 7, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery drape
Medical Devices·769,810 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape
Medical Devices·2,779,810 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape
Medical Devices·26,160 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape
Medical Devices·248,750 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape
Medical Devices·17,200 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape
Medical Devices·84,000 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general surgery drape
Medical Devices·14,360 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surgery drape
Medical Devices·43,200 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape
Medical Devices·807,720 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery drape
Medical Devices·103,000 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape
Medical Devices·104,000 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape
Medical Devices·504,000 affected·Oct 6, 2022
High RiskFDA
3m Healthcare Business
3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape
Medical Devices·36,020 affected·Oct 6, 2022
High RiskFDA
Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Medical Devices·17,700 affected·Oct 4, 2022
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for use with BD FACSLyric, BD FACSCanto II, and BD FACSCanto...
Medical Devices·1,457 affected·Oct 3, 2022
High RiskFDA
Beckman Coulter, Inc.
MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Medical Devices·53 affected·Oct 3, 2022
High RiskFDA
Medline Industries, Lp - Northfield
CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical procedures.
Medical Devices·50 affected·Sep 30, 2022
CriticalFDA
Baxter Healthcare Corporation
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.
Medical Devices·1,137 affected·Sep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE DENTAL PACK, REF DYNJ66983. Convenience kit used in medical procedures.
Medical Devices·60 affected·Sep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures.
Medical Devices·50 affected·Sep 30, 2022
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures.
Medical Devices·240 affected·Sep 30, 2022
High RiskFDA
Wright Medical Technology, Inc.
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
Medical Devices·1 affected·Sep 30, 2022
CriticalFDA
Baxter Healthcare Corporation
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P00697905
Medical Devices·814 affected·Sep 30, 2022