Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Life Technologies Holdings Pte Ltd
Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
Medical Devices·400 affected·Sep 26, 2019
RecallFDA
Theralase Inc.
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
Medical Devices·306 affected·Sep 26, 2019
RecallFDA
Theralase Inc.
TLC-2000 Therapeutic Medical Laser System
Medical Devices·92 affected·Sep 26, 2019
High RiskFDA
Brainlab Ag
Patient Data Manager, Model/Catalogue Numbers: 25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY 25100-10 - PATIENT DATA MANAGER 2.2....
Medical Devices·1,230 affected·Sep 25, 2019
High RiskFDA
Vygon Mfg, Inc., Dba/ Churchill Medical Systems, Inc.
4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
Medical Devices·75 affected·Sep 24, 2019
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
Medical Devices·14 affected·Sep 24, 2019
High RiskFDA
Elekta Impac Software
MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment plan...
Medical Devices·3,732 affected·Sep 24, 2019
High RiskFDA
Tomtec Imaging Systems Gmbh
TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable U...
Medical Devices·62 affected·Sep 23, 2019
RecallFDA
Randox Laboratories, Limited
RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.
Medical Devices·212 affected·Sep 23, 2019
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica CH 930 Analyzer
Medical Devices·1,432 affected·Sep 23, 2019
High RiskFDA
Blue Ortho
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Re...
Medical Devices·7 affected·Sep 22, 2019
High RiskFDA
Baxter Healthcare Corporation
TherMax Blood Warmer Unit
Medical Devices·504 affected·Sep 19, 2019
High RiskFDA
Pacific Medical Group Inc.
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
Medical Devices·678 affected·Sep 19, 2019
High RiskFDA
Pacific Medical Group Inc.
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205
Medical Devices·295 affected·Sep 19, 2019
High RiskFDA
Pacific Medical Group Inc.
Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250
Medical Devices·261 affected·Sep 19, 2019
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the central venous sy...
Medical Devices·582 affected·Sep 18, 2019
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
BIOFLO 8F SINGLE PLASTIC FILLED; VALVED, UPN H965440220, Cat. No. 44-022
Medical Devices·582 affected·Sep 18, 2019
High RiskFDA
Baxter Healthcare Corporation
EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 50...
Medical Devices·11,389,800 affected·Sep 18, 2019
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the central venous syst...
Medical Devices·582 affected·Sep 18, 2019
High RiskFDA
Boston Scientific Corporation
iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System
Medical Devices·150 affected·Sep 18, 2019
High RiskFDA
Gn Hearing A/s
In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-HP, FT8ITC-W-LP, FT8ITC-W-MP, FT8ITE-D...
Medical Devices·285 affected·Sep 18, 2019
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - Product Usage: Long-term access to the central venous sys...
Medical Devices·582 affected·Sep 18, 2019
High RiskFDA
Cook Inc.
Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for...
Medical Devices·41 affected·Sep 17, 2019
CriticalFDA
Cme America, Llc
BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infu...
Medical Devices·69,400 affected·Sep 16, 2019
High RiskFDA
Codan Us Corporation
CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile. The firm name on...
Medical Devices·34,776 affected·Sep 12, 2019
High RiskFDA
Olympus Corporation Of The Americas
Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of ...
Medical Devices·1,106 affected·Sep 12, 2019
High RiskFDA
Integra Lifesciences Corp.
Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers an...
Medical Devices·189 affected·Sep 12, 2019
High RiskFDA
Merit Medical Systems, Inc.
Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introductio...
Medical Devices·15 affected·Sep 12, 2019
CriticalFDA
Pacific Medical Group Inc.
Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips M1356A Ultrasound Board, NFPH9510...
Medical Devices·1,994 affected·Sep 11, 2019
CriticalFDA
Pacific Medical Group Inc.
Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toc...
Medical Devices·10,911 affected·Sep 11, 2019
CriticalFDA
Pacific Medical Group Inc.
Toco MP Transducer (M2734B), that may have been serviced with the following: Pacific Medical Philips M2734B Avalon Smart TOCO Bottom Case...
Medical Devices·1,776 affected·Sep 11, 2019
CriticalFDA
Pacific Medical Group Inc.
Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may have been serviced with the following: Pacific Medical GE Co...
Medical Devices·6,481 affected·Sep 11, 2019
CriticalFDA
Pacific Medical Group Inc.
Toco M2734A, that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Paci...
Medical Devices·466 affected·Sep 11, 2019
CriticalFDA
Pacific Medical Group Inc.
Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the following: Pacific Medical GE Coro...
Medical Devices·6,797 affected·Sep 11, 2019
High RiskFDA
Alto Development Corp
A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum.
Medical Devices·209 affected·Sep 10, 2019
High RiskFDA
Alto Development Corp
A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum.
Medical Devices·209 affected·Sep 10, 2019
CriticalFDA
Medtech Sas
Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film...
Medical Devices·93 affected·Sep 10, 2019
RecallFDA
Coopersurgical, Inc.
Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Fr...
Medical Devices·60 affected·Sep 5, 2019
High RiskFDA
Carroll-baccari, Inc.
Pedia Prep: MD0033T - 4 oz tubes MD0033--SUP - Single Use Cups Skin preparation used to enhance signal quality of patient recordin...
Medical Devices·2,445 affected·Sep 5, 2019
High RiskFDA
Synthes (usa) Products Llc
MODIFIED INSTRUMENTS: Trial Spacer 7mm with T-Handle Trial Spacer 8mm with T-Handle Trial Spacer 9mm with T-Handle Trial Spacer 10mm ...
Medical Devices·9 affected·Sep 5, 2019
High RiskFDA
Beckman Coulter Inc.
MicroScan WalkAway-40 plus Instrument
Medical Devices·16 affected·Sep 4, 2019
High RiskFDA
Beckman Coulter Inc.
MicroScan WalkAway-40 plus Reconditioned Instrument
Medical Devices·6 affected·Sep 4, 2019
High RiskFDA
Elekta Inc
Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans fo...
Medical Devices·49 affected·Sep 4, 2019
High RiskFDA
Elekta Inc
Monaco RTP System, 5.40 Unity, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans f...
Medical Devices·30 affected·Sep 4, 2019
High RiskFDA
Beckman Coulter Inc.
MicroScan WalkAway-96 plus Reconditioned Instrument
Medical Devices·9 affected·Sep 4, 2019
High RiskFDA
Ge Healthcare, Llc
Achilles Express Bone Sonometer
Medical Devices·241 affected·Sep 3, 2019
High RiskFDA
Ge Healthcare, Llc
Achilles Insight Bone Sonometer
Medical Devices·599 affected·Sep 3, 2019
High RiskFDA
Spacelabs Healthcare, Inc.
Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and ne...
Medical Devices·2,197 affected·Aug 30, 2019