Category

Medical Devices Recalls

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

15,654 recalls
CriticalFDA
Zyno Medical Llc
Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Medical Devices·613 affected·May 7, 2025
RecallFDA
Lumithera Inc
Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description:...
Medical Devices·8 affected·May 7, 2025
High RiskFDA
Copan Wasp
PhenoMATRIX
Medical Devices·14 affected·May 6, 2025
High RiskFDA
Baxter Healthcare Corporation
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, ...
Medical Devices·164 affected·May 6, 2025
High RiskFDA
Olympus Corporation Of The Americas
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Medical Devices·12,195 affected·May 5, 2025
High RiskFDA
Asp Global, Llc. Dba Anatomy Supply Partners, Llc.
SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary ...
Medical Devices·4,272,858 affected·May 5, 2025
High RiskFDA
Healthmark Industries Co., Inc.
ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
Medical Devices·193,035 affected·May 2, 2025
High RiskFDA
Implant Direct Sybron Manufacturing Llc
The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitat...
Medical Devices·45 affected·May 1, 2025
High RiskFDA
Beckman Coulter Mishima K.k.
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 17943...
Medical Devices·10,176 affected·Apr 30, 2025
High RiskFDA
Maquet Cardiopulmonary Ag
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Medical Devices·2 affected·Apr 30, 2025
High RiskFDA
Beckman Coulter Mishima K.k.
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 17943...
Medical Devices·6,166 affected·Apr 30, 2025
High RiskFDA
Medtronic, Inc.
Azure S DR MRI SureScan, Product number W3DR01
Medical Devices·6 affected·Apr 29, 2025
High RiskFDA
Tecfen Medical
Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product...
Medical Devices·26 affected·Apr 25, 2025
RecallFDA
Hangzhou Acosound Technology Co., Ltd.
AcoSound. Model Number: LW12-BTE-M
Medical Devices·120 affected·Apr 25, 2025
High RiskFDA
Tecfen Medical
Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No softw...
Medical Devices·42 affected·Apr 25, 2025
High RiskFDA
Tecfen Medical
Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Des...
Medical Devices·1,400 affected·Apr 25, 2025
High RiskFDA
Tecfen Medical
Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 Software Version: No software Product...
Medical Devices·47 affected·Apr 25, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
Medical Devices·25 affected·Apr 24, 2025
High RiskFDA
Mobius Mobility Llc
iBOT PMD with software version 01.05.24. Personal Mobility Device.
Medical Devices·442 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
ABBOTT RAPID DX N AMERICA LLC, TEST CHOLESTEC LDXLIPID PROFILE (10/BX 50BX/CS) CASSETTES.
Medical Devices·100 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
Medical Devices·1 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
Medical Devices·100 affected·Apr 24, 2025
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
Medical Devices·1 affected·Apr 24, 2025
CriticalFDA
Baxter Healthcare Corporation
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Medical Devices·34,524 affected·Apr 24, 2025
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRA...
Medical Devices·1,853 affected·Apr 22, 2025
High RiskFDA
3m Company
3M Ranger Irrigation Fluid Warming Set, REF 24750
Medical Devices·186,880 affected·Apr 22, 2025
CriticalFDA
Medline Industries, Lp - Northfield
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
Medical Devices·1,853 affected·Apr 22, 2025
CriticalFDA
C.r. Bard Inc
Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
Medical Devices·0 affected·Apr 17, 2025
High RiskFDA
Cook Incorporated
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Medical Devices·99 affected·Apr 17, 2025
High RiskFDA
Cook Incorporated
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Medical Devices·89 affected·Apr 17, 2025
CriticalFDA
C.r. Bard Inc
Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
Medical Devices·0 affected·Apr 17, 2025
High RiskFDA
Cook Incorporated
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular le...
Medical Devices·2,952 affected·Apr 17, 2025
High RiskFDA
Remote Diagnostic Technologies Ltd.
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Medical Devices·6,961 affected·Apr 15, 2025
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Medical Devices·2,212 affected·Apr 15, 2025
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
Medical Devices·1,072 affected·Apr 15, 2025
High RiskFDA
Ortho-clinical Diagnostics, Inc.
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
Medical Devices·3,587 affected·Apr 14, 2025
High RiskFDA
Microtek Medical, Inc.
Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Dr...
Medical Devices·2,024 affected·Apr 13, 2025
CriticalFDA
Integra Lifesciences Corp. (neurosciences)
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Medical Devices·1,840 affected·Apr 11, 2025
CriticalFDA
Smiths Medical Asd, Inc.
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUA...
Medical Devices·185,975 affected·Apr 10, 2025
CriticalFDA
3m Company
3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370
Medical Devices·530,470 affected·Apr 10, 2025
CriticalFDA
Smiths Medical Asd, Inc.
CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-...
Medical Devices·185,975 affected·Apr 10, 2025
CriticalFDA
Smiths Medical Asd, Inc.
CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 2...
Medical Devices·313,676 affected·Apr 10, 2025
CriticalFDA
Smiths Medical Asd, Inc.
CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) P...
Medical Devices·313,676 affected·Apr 10, 2025
CriticalFDA
Smiths Medical Asd, Inc.
CADD Solis HSPCA Pump
Medical Devices·83,833 affected·Apr 10, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Centurion Sterile Weitlaner Retractor 3 x 4 Prong, Reorder: I68395
Medical Devices·840 affected·Apr 9, 2025
CriticalFDA
Richard Wolf Gmbh
PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with pie...
Medical Devices·31 affected·Apr 9, 2025
High RiskFDA
Inari Medical - Oak Canyon
Artix MT Thrombectomy Device, REF: 32-102
Medical Devices·45 affected·Apr 8, 2025
High RiskFDA
Beckman Coulter Inc.
REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69...
Medical Devices·1,805 affected·Apr 8, 2025