Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Philips Headquarters Cambridge
Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
Medical Devices·7 affected·Apr 12, 2023
CriticalFDA
Teleflex Llc
Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral a...
Medical Devices·1,140 affected·Apr 12, 2023
High RiskFDA
Philips Headquarters Cambridge
Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
Medical Devices·22 affected·Apr 12, 2023
High RiskFDA
Philips Headquarters Cambridge
Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
Medical Devices·5 affected·Apr 12, 2023
High RiskFDA
Bard Peripheral Vascular Inc
Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
Medical Devices·4,120 affected·Apr 11, 2023
CriticalFDA
Medtronic Navigation, Inc.
StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
Medical Devices·746 affected·Apr 11, 2023
High RiskFDA
Shimadzu Corporation Medical Systems Division
Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpe...
Medical Devices·1,836 affected·Apr 10, 2023
High RiskFDA
Wright Medical Technology, Inc.
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
Medical Devices·50 affected·Apr 10, 2023
High RiskFDA
Wright Medical Technology, Inc.
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
Medical Devices·41 affected·Apr 10, 2023
CriticalFDA
Cook Incorporated
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100...
Medical Devices·25,161 affected·Apr 7, 2023
CriticalFDA
Cook Incorporated
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G...
Medical Devices·3 affected·Apr 7, 2023
High RiskFDA
3m Company - Health Care Business
3M Attest Steam Chemical Integrators, REF 1243B
Medical Devices·2,235,000 affected·Apr 6, 2023
High RiskFDA
Karl Storz Endoscopy
Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, REF: 11580C; Me...
Medical Devices·4,933 affected·Apr 6, 2023
CriticalFDA
Fisher Wallace Laboratories Inc.
Fisher Wallace Stimulator Models FW-100 and FW-200
Medical Devices·43,489 affected·Apr 6, 2023
High RiskFDA
Cardinal Health 200, Llc
Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery
Medical Devices·5 affected·Apr 6, 2023
High RiskFDA
Boston Scientific Corporation
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Medical Devices·1,300 affected·Apr 5, 2023
High RiskFDA
Illumina, Inc.
MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
Medical Devices·740 affected·Apr 5, 2023
High RiskFDA
Boston Scientific Corporation
WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
Medical Devices·10,833 affected·Apr 5, 2023
High RiskFDA
Smiths Medical Asd Inc.
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with breat...
Medical Devices·47,007 affected·Apr 5, 2023
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
Medical Devices·48,633 affected·Apr 5, 2023
High RiskFDA
Beckman Coulter Inc.
Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL
Medical Devices·48,633 affected·Apr 5, 2023
High RiskFDA
Karl Storz Endoscopy
KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
Medical Devices·4,386 affected·Apr 5, 2023
High RiskFDA
Illumina, Inc.
NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
Medical Devices·1,067 affected·Apr 5, 2023
High RiskFDA
Carefusion 303, Inc.
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Medical Devices·622 affected·Apr 5, 2023
High RiskFDA
Smiths Medical Asd Inc.
DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505); Swivel Elbow with Suction Port for use with b...
Medical Devices·14,941 affected·Apr 5, 2023
High RiskFDA
Datascope Corp.
MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
Medical Devices·54 affected·Apr 4, 2023
High RiskFDA
Ethicon, Inc.
PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tis...
Medical Devices·1,656 affected·Mar 31, 2023
CriticalFDA
Sd Biosensor, Inc.
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
Medical Devices·2,712,767 affected·Mar 31, 2023
RecallFDA
Olympus Corporation Of The Americas
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of...
Medical Devices·2,058 affected·Mar 31, 2023
RecallFDA
Olympus Corporation Of The Americas
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the trac...
Medical Devices·1,297 affected·Mar 31, 2023
High RiskFDA
J&t Health And Wellness Llc
ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device
Medical Devices·12 affected·Mar 31, 2023
High RiskFDA
Baxter Healthcare Corporation
Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 2164...
Medical Devices·5,549 affected·Mar 31, 2023
High RiskFDA
Apothecary Products, Llc
Eye and Ear Dropper, Product Code 67082
Medical Devices·2,346 affected·Mar 30, 2023
High RiskFDA
Apothecary Products, Llc
Medicine Dropper, Product Code K508
Medical Devices·1,596 affected·Mar 30, 2023
High RiskFDA
Surgical Innovations Ltd
YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR
Medical Devices·3,405 affected·Mar 28, 2023
High RiskFDA
Medline Industries, Lp - Northfield
DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
Medical Devices·9,945 affected·Mar 28, 2023
High RiskFDA
Smith & Nephew, Inc.
JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
Medical Devices·12 affected·Mar 27, 2023
High RiskFDA
Technidata S.a.
TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecologic...
Medical Devices·1 affected·Mar 27, 2023
High RiskFDA
Omnicell, Inc.
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
Medical Devices·6 affected·Mar 27, 2023
CriticalFDA
Cordis Us Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
Medical Devices·40 affected·Mar 24, 2023
CriticalFDA
Cordis Us Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
Medical Devices·56 affected·Mar 24, 2023
CriticalFDA
Cordis Us Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
Medical Devices·146 affected·Mar 24, 2023
CriticalFDA
Cordis Us Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
Medical Devices·27 affected·Mar 24, 2023
CriticalFDA
Cordis Us Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
Medical Devices·0 affected·Mar 24, 2023
CriticalFDA
Cordis Us Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
Medical Devices·684 affected·Mar 24, 2023
High RiskFDA
Aso Llc
WALGREENS BANDAGES, item number 196568, 110 CT VALUE PACK, 24 BOXES/MASTER (shipping container), Walgreens Family Pack ASSORTED BANDAGES,...
Medical Devices·919 affected·Mar 23, 2023
CriticalFDA
Icu Medical Inc
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
Medical Devices·28,656 affected·Mar 22, 2023
CriticalFDA
Icu Medical Inc
ASM Replacement Battery, Component Number SUB0000864
Medical Devices·9,984 affected·Mar 22, 2023