Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Microbiologics Inc
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Medical Devices·1 affected·Dec 2, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RaySt...
Medical Devices·0 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023...
Medical Devices·119 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, R...
Medical Devices·0 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Descr...
Medical Devices·0 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1...
Medical Devices·22 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: Ray...
Medical Devices·8 affected·Nov 28, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStat...
Medical Devices·10 affected·Nov 28, 2025
High RiskFDA
Baxter Healthcare Corporation
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Medical Devices·585 affected·Nov 28, 2025
High RiskFDA
Medline Industries, Lp
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit ...
Medical Devices·16 affected·Nov 26, 2025
High RiskFDA
Cook Incorporated
Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3...
Medical Devices·7,952 affected·Nov 26, 2025
CriticalFDA
Medline Industries, Lp
MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L
Medical Devices·35,694 affected·Nov 26, 2025
CriticalFDA
Medline Industries, Lp
MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO
Medical Devices·22,565 affected·Nov 26, 2025
CriticalFDA
Medline Industries, Lp
MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pack,REF MDR107003E-4.
Medical Devices·138,412 affected·Nov 26, 2025
High RiskFDA
Medline Industries, Lp
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1...
Medical Devices·11,173 affected·Nov 26, 2025
High RiskFDA
Medline Industries, Lp
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DY...
Medical Devices·32 affected·Nov 26, 2025
High RiskFDA
Medline Industries, Lp
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Ki...
Medical Devices·10 affected·Nov 26, 2025
CriticalFDA
Medline Industries, Lp
MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO
Medical Devices·15,581 affected·Nov 26, 2025
High RiskFDA
Remote Diagnostic Technologies Ltd.
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: ...
Medical Devices·7,129 affected·Nov 26, 2025
High RiskFDA
Medline Industries, Lp
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1...
Medical Devices·1,725 affected·Nov 26, 2025
CriticalFDA
Medline Industries, Lp
MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L
Medical Devices·13,245 affected·Nov 26, 2025
High RiskFDA
Ferndale Laboratories, Inc.
Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive,...
Medical Devices·24,589 affected·Nov 25, 2025
High RiskFDA
Smith & Nephew, Inc.
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Medical Devices·168 affected·Nov 24, 2025
High RiskFDA
Icu Medical, Inc.
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Medical Devices·7 affected·Nov 24, 2025
High RiskFDA
Zimmer Surgical Inc
Zimmer Air Dermatome, Model/Catalog Number: 00880100100
Medical Devices·839 affected·Nov 24, 2025
CriticalFDA
Draeger, Inc.
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
Medical Devices·431 affected·Nov 24, 2025
High RiskFDA
Icu Medical, Inc.
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Medical Devices·12 affected·Nov 24, 2025
High RiskFDA
Changchun Wancheng Bio-electron Co., Ltd.
Male Fertility Sperm Test for Home Use (Cassette)
Medical Devices·1,000 affected·Nov 22, 2025
High RiskFDA
Changchun Wancheng Bio-electron Co., Ltd.
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Medical Devices·4,800 affected·Nov 22, 2025
High RiskFDA
Changchun Wancheng Bio-electron Co., Ltd.
Vivoo Protein Test
Medical Devices·500 affected·Nov 22, 2025
High RiskFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Medical Devices·30 affected·Nov 21, 2025
High RiskFDA
Carefusion 303, Inc.
BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD ...
Medical Devices·53,669 affected·Nov 20, 2025
High RiskFDA
Medtronic Neuromodulation
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABL...
Medical Devices·7,667 affected·Nov 20, 2025
RecallFDA
Instrumentation Laboratory
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Medical Devices·4,506 affected·Nov 18, 2025
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Mod...
Medical Devices·906 affected·Nov 18, 2025
High RiskFDA
Agfa Healthcare Corp.
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
Medical Devices·35 affected·Nov 18, 2025
High RiskFDA
Etac A/s
Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 ...
Medical Devices·25 affected·Nov 17, 2025
High RiskFDA
Sophysa
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Medical Devices·105 affected·Nov 17, 2025
High RiskFDA
Etac A/s
Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M...
Medical Devices·95 affected·Nov 17, 2025
High RiskFDA
Olympus Corporation Of The Americas
Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Pr...
Medical Devices·1,684 affected·Nov 14, 2025
High RiskFDA
Avid Medical, Inc.
Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
Medical Devices·300 affected·Nov 14, 2025
High RiskFDA
Avid Medical, Inc.
Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Medical Devices·240 affected·Nov 14, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 ...
Medical Devices·1,277 affected·Nov 14, 2025
High RiskFDA
Avid Medical, Inc.
Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
Medical Devices·90 affected·Nov 14, 2025
High RiskFDA
Avid Medical, Inc.
Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.
Medical Devices·56 affected·Nov 14, 2025
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Medical Devices·30 affected·Nov 14, 2025
High RiskFDA
Abbott Laboratories
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Medical Devices·11,653 affected·Nov 13, 2025
High RiskFDA
Microbiologics Inc
KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Medical Devices·5 affected·Nov 13, 2025