Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Karl Storz Endoscopy
11272VH-TL 11272VHK-TL HD-VIEW Flexible HD Cysto-Urethroscope Z23875US-BC (10-2021) 11272VHU-TL 11272VHUK-TL HD-VIEW Flexible HD Cysto-...
Medical Devices·2,018 affected·Apr 1, 2022
High RiskFDA
Karl Storz Endoscopy
11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URET...
Medical Devices·2,018 affected·Apr 1, 2022
High RiskFDA
Getinge Usa Sales Inc
Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Medical Devices·127 affected·Apr 1, 2022
High RiskFDA
Karl Storz Endoscopy
11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope...
Medical Devices·2,018 affected·Apr 1, 2022
High RiskFDA
Karl Storz Endoscopy
11278VSA 11278VSAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VSE 11278VSEK Flexible Video-Uretero-Renoscope...
Medical Devices·2,018 affected·Apr 1, 2022
High RiskFDA
Karl Storz Endoscopy
11274BCU1 11274BCUK1 Flexible Cystoscope Z18449US-BD (08-2018)
Medical Devices·2,018 affected·Apr 1, 2022
High RiskFDA
Karl Storz Endoscopy
11272VUE 11272VUEK Flexible Video Cysto-Urethroscope 96136031USCA V1.1 (04/2021); 11272VUE-R 11272VUEK-R Flexible Video Cysto-Urethrosco...
Medical Devices·2,018 affected·Apr 1, 2022
High RiskFDA
Howmedica Osteonics Corp.
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number...
Medical Devices·22 affected·Mar 30, 2022
High RiskFDA
Invacare Corporation
Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
Medical Devices·133 affected·Mar 30, 2022
High RiskFDA
Devicor Medical Products Inc
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Medical Devices·90 affected·Mar 30, 2022
High RiskFDA
Biomerieux, Inc.
VITEK 2 Systems and VITEK 2 with MYLA.
Medical Devices·21,757 affected·Mar 29, 2022
High RiskFDA
Philips North America Llc
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images...
Medical Devices·330 affected·Mar 29, 2022
High RiskFDA
Arthrex, Inc.
K-Wire, 1.35 mm x 170 mm
Medical Devices·300 affected·Mar 25, 2022
RecallFDA
Randox Laboratories Ltd.
CK MB Calibrator, Catalogue Number CK2393
Medical Devices·1,392 affected·Mar 25, 2022
High RiskFDA
Microbiologics Inc
Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Medical Devices·1 affected·Mar 24, 2022
High RiskFDA
Ethicon, Inc.
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code...
Medical Devices·2,808 affected·Mar 24, 2022
High RiskFDA
American Contract Systems, Inc.
ACS Cath Lab Pack
Medical Devices·10 affected·Mar 22, 2022
High RiskFDA
American Contract Systems, Inc.
ACS Lap Chole Pack
Medical Devices·20 affected·Mar 22, 2022
High RiskFDA
Microbiologics Inc
Inactivated macrolide-resistant Mycoplasma genitalium
Medical Devices·2 affected·Mar 22, 2022
High RiskFDA
Steris Corporation
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100
Medical Devices·103 affected·Mar 22, 2022
High RiskFDA
Acera Surgical Inc
Restrata, Part Number RWM1-2X2
Medical Devices·83 affected·Mar 21, 2022
High RiskFDA
Waters Medical Systems Llc
WAVES WCM Kidney Cassette Module
Medical Devices·75 affected·Mar 21, 2022
High RiskFDA
Roi Cps Llc
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Deli...
Medical Devices·1,501 affected·Mar 18, 2022
High RiskFDA
Roi Cps Llc
Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor...
Medical Devices·950 affected·Mar 18, 2022
High RiskFDA
Olympus Corporation Of The Americas
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Medical Devices·731 affected·Mar 18, 2022
High RiskFDA
Clinician's Choice Dental Products Inc.
Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a re...
Medical Devices·46 affected·Mar 18, 2022
High RiskFDA
Intuitive Surgical, Inc.
da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi ...
Medical Devices·68,881 affected·Mar 17, 2022
High RiskFDA
Ge Healthcare, Llc
MUSE Cardiology Information System, Model Numbers: a) 3101011-040, b) 3101010-401, c) 3101010-009, d) 3101010-008
Medical Devices·147 affected·Mar 16, 2022
High RiskFDA
Carl Zeiss Meditec Ag
ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Medical Devices·1,225 affected·Mar 16, 2022
High RiskFDA
Baxter Healthcare Corporation
PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
Medical Devices·3,513 affected·Mar 15, 2022
High RiskFDA
Baxter Healthcare Corporation
PrisMax System, Product Code 955724
Medical Devices·296 affected·Mar 15, 2022
High RiskFDA
Graphic Controls Acquisition Corporation
CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
Medical Devices·560 affected·Mar 15, 2022
High RiskFDA
Augustine Temperature Management, Llc
Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
Medical Devices·77 affected·Mar 14, 2022
CriticalFDA
Sensory Medical Inc
Cub 2 Enclosed Bed Canopy System
Medical Devices·225 affected·Mar 14, 2022
High RiskFDA
Sartorius Corporation
Virus Counter Platform with Model Name VC3100
Medical Devices·82 affected·Mar 11, 2022
High RiskFDA
Abbott Vascular
Plus 30 Priority Pack w/.096 RHV - REF 1000183 WPL2122277-01 (20-03-01) Plus 30 Priority Pack w/.115 RHV - REF 1000185-115 WPL2122279-...
Medical Devices·7 affected·Mar 11, 2022
High RiskFDA
Abbott Vascular
INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
Medical Devices·6 affected·Mar 11, 2022
High RiskFDA
Total Resources Intl
Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3. Kit contents include ULTRAtab Laboratories Elect...
Medical Devices·891 affected·Mar 11, 2022
High RiskFDA
Depuy Orthopaedics, Inc.
VELYS Robotic-Assisted Solution Base Product No.: 451570100
Medical Devices·68 affected·Mar 11, 2022
High RiskFDA
Abbott Vascular
20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
Medical Devices·17 affected·Mar 11, 2022
High RiskFDA
Medline Industries, Lp - Northfield
Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
Medical Devices·8,990 affected·Mar 9, 2022
High RiskFDA
Becton Dickinson & Co.
BD Synapsys Microbiology Informatics Solution, Catalog Number 444150, Software Version 4.10
Medical Devices·15 affected·Mar 9, 2022
High RiskFDA
Acumed Llc
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Medical Devices·537 affected·Mar 9, 2022
High RiskFDA
Olympus Corporation Of The Americas
BF-3C160: EVIS EXERA Bronchovideoscope
Medical Devices·1,052 affected·Mar 8, 2022
High RiskFDA
Olympus Corporation Of The Americas
BF-MP160F: EVIS EXERA Bronchofibervideoscope
Medical Devices·292 affected·Mar 8, 2022
High RiskFDA
Boston Scientific Corporation
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Medical Devices·433 affected·Mar 8, 2022
High RiskFDA
Boston Scientific Corporation
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
Medical Devices·488 affected·Mar 8, 2022
High RiskFDA
Olympus Corporation Of The Americas
BF-MP60: OES Bronchofiberscope
Medical Devices·60 affected·Mar 8, 2022