Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator...
Medical Devices·291 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·264 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·451 affected·Oct 25, 2023
High RiskFDA
Riverpoint Medical, Llc
Iconix Knotless 1.4mm Anchor with XBraid S (Blue/Black) REF 3911-714-520 Iconix Knotless 1.4mm Anchor with XBraid S (Black/White) REF...
Medical Devices·999 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·47 affected·Oct 25, 2023
High RiskFDA
Becton, Dickinson And Company, Bd Biosciences
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Medical Devices·464 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·1,019 affected·Oct 25, 2023
High RiskFDA
Elekta, Inc.
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
Medical Devices·315 affected·Oct 25, 2023
High RiskFDA
Cardioquip, Llc
CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
Medical Devices·2 affected·Oct 24, 2023
High RiskFDA
Graphenano Dental Sl
GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichrom...
Medical Devices·354 affected·Oct 24, 2023
High RiskFDA
Karl Storz Endoscopy
Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
Medical Devices·990 affected·Oct 24, 2023
High RiskFDA
Cardioquip, Llc
CardioQuip Modular Cooler-Heater, Model: MCH-1000(i), Power: 115V-60Hz, 16A
Medical Devices·4 affected·Oct 24, 2023
High RiskFDA
Karl Storz Endoscopy
Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, RE...
Medical Devices·4,878 affected·Oct 24, 2023
High RiskFDA
Karl Storz Endoscopy
Injection Needle, single cvd. 70 degrees, REF: 738750; Injection Needle, single cvd. 80 degrees, REF: 738752; Injection Needle, bayonet, ...
Medical Devices·4,470 affected·Oct 24, 2023
High RiskFDA
Karl Storz Endoscopy
Injection Needle, LUER-lock,0.8mm, REF: 26175PD
Medical Devices·1,127 affected·Oct 24, 2023
High RiskFDA
Sage Products Inc
stryker Sage PrimaFit External Urine Management System for the Female Anatomy
Medical Devices·174,960 affected·Oct 23, 2023
CriticalFDA
Philips North America Llc
SmartPath to dStream for 1.5T
Medical Devices·119 affected·Oct 23, 2023
CriticalFDA
Philips North America Llc
Ingenia 1.5T CX
Medical Devices·48 affected·Oct 23, 2023
CriticalFDA
Philips North America Llc
Achieva 1.5T
Medical Devices·520 affected·Oct 23, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial Access Kit - For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7040
Medical Devices·59 affected·Oct 19, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Leg bag, REF URO12573
Medical Devices·144 affected·Oct 19, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Leg bag, REF DYND12574
Medical Devices·28,942 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the b...
Medical Devices·1,639 affected·Oct 19, 2023
CriticalFDA
Cardioquip, Llc
CardioQuip Modular Cooler-Heater, Model:MCH-1000(i), Power: 115V-60hz,16A
Medical Devices·125 affected·Oct 19, 2023
High RiskFDA
Siemens Healthcare Diagnostics Inc
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW),...
Medical Devices·10,183 affected·Oct 19, 2023
High RiskFDA
Meridian Bioscience Inc
Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens co...
Medical Devices·38 affected·Oct 19, 2023
CriticalFDA
Cardioquip, Llc
CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
Medical Devices·150 affected·Oct 19, 2023
High RiskFDA
Meridian Bioscience Inc
Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal ...
Medical Devices·201 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04
Medical Devices·173 affected·Oct 19, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Leg bag, REF DYND12578
Medical Devices·19,406 affected·Oct 19, 2023
High RiskFDA
Abbott Laboratories
Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01. Multi-p...
Medical Devices·670 affected·Oct 19, 2023
High RiskFDA
Abbott Laboratories
ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module...
Medical Devices·995 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP06
Medical Devices·160 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial Access Kit -For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7270
Medical Devices·173 affected·Oct 19, 2023
High RiskFDA
Integra Lifesciences Corp.
Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260
Medical Devices·510 affected·Oct 19, 2023
High RiskFDA
Auris Health Inc
Monarch Platform REF MON-000006 100-240V- 50/60Hz 1440w
Medical Devices·110 affected·Oct 18, 2023
High RiskFDA
Microbiologics Inc
KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
Medical Devices·13 affected·Oct 18, 2023
High RiskFDA
Auris Health Inc
Monarch Platform REF MON-000005-01R, 100-240V- 50/60Hz 1440w
Medical Devices·110 affected·Oct 18, 2023
High RiskFDA
Emd Millipore Corporation
Lugol s Iodine Solution 500ML, Part Number 624-71
Medical Devices·5 affected·Oct 17, 2023
High RiskFDA
Biofire Diagnostics, Llc
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArr...
Medical Devices·32,910 affected·Oct 17, 2023
High RiskFDA
Aizu Olympus Co., Ltd.
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Medical Devices·24 affected·Oct 16, 2023
High RiskFDA
Aizu Olympus Co., Ltd.
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
Medical Devices·24 affected·Oct 16, 2023
High RiskFDA
Aizu Olympus Co., Ltd.
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
Medical Devices·24 affected·Oct 16, 2023
High RiskFDA
Corin Ltd
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
Medical Devices·1 affected·Oct 13, 2023
CriticalFDA
Olympus Corporation Of The Americas
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
Medical Devices·3,948 affected·Oct 12, 2023
CriticalFDA
Olympus Corporation Of The Americas
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
Medical Devices·719 affected·Oct 12, 2023
High RiskFDA
Medtronic Inc
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
Medical Devices·173 affected·Oct 12, 2023
High RiskFDA
Medtronic Inc
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
Medical Devices·48 affected·Oct 12, 2023