Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Aesculap Ag
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Medical Devices·1 affected·Aug 18, 2025
High RiskFDA
Boston Scientific Corporation
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Medical Devices·1 affected·Aug 18, 2025
High RiskFDA
Corneat Vision, Ltd.
EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202
Medical Devices·180 affected·Aug 18, 2025
High RiskFDA
Exactech, Inc.
Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINE...
Medical Devices·11,542 affected·Aug 15, 2025
High RiskFDA
Mindray Ds Usa, Inc. Dba Mindray North America
BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA0001...
Medical Devices·2,278 affected·Aug 15, 2025
RecallFDA
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 360020-1P
Medical Devices·45 affected·Aug 13, 2025
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322
Medical Devices·0 affected·Aug 13, 2025
RecallFDA
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 360020-1EP
Medical Devices·10 affected·Aug 13, 2025
RecallFDA
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 36...
Medical Devices·206 affected·Aug 13, 2025
High RiskFDA
Change Healthcare Canada Company
Change Healthcare Radiology Solutions software version 14.2.2
Medical Devices·12 affected·Aug 13, 2025
High RiskFDA
Philips North America Llc
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
Medical Devices·210 affected·Aug 13, 2025
High RiskFDA
Beta Bionics, Inc.
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
Medical Devices·15 affected·Aug 13, 2025
High RiskFDA
Philips North America Llc
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
Medical Devices·81 affected·Aug 13, 2025
High RiskFDA
Philips North America Llc
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Numbe...
Medical Devices·33 affected·Aug 13, 2025
High RiskFDA
Philips North America Llc
Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.
Medical Devices·3 affected·Aug 13, 2025
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
Medical Devices·0 affected·Aug 13, 2025
High RiskFDA
Philips North America Llc
Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
Medical Devices·6 affected·Aug 13, 2025
High RiskFDA
Philips North America Llc
Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number...
Medical Devices·73 affected·Aug 13, 2025
RecallFDA
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
Medical Devices·190 affected·Aug 13, 2025
High RiskFDA
Philips North America Llc
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model...
Medical Devices·181 affected·Aug 13, 2025
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520
Medical Devices·0 affected·Aug 13, 2025
RecallFDA
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010...
Medical Devices·643 affected·Aug 13, 2025
RecallFDA
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-...
Medical Devices·158 affected·Aug 13, 2025
RecallFDA
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 860010-1L
Medical Devices·26 affected·Aug 13, 2025
RecallFDA
Penner Patient Care, Inc.
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL
Medical Devices·15 affected·Aug 13, 2025
High RiskFDA
Beckman Coulter Inc.
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858
Medical Devices·0 affected·Aug 13, 2025
CriticalFDA
Max Mobility Llc
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Ass...
Medical Devices·8,413 affected·Aug 12, 2025
CriticalFDA
Max Mobility Llc
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assis...
Medical Devices·25,389 affected·Aug 12, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Medical Devices·20 affected·Aug 12, 2025
High RiskFDA
Applied Medical Technology Inc
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tube is a feeding tu...
Medical Devices·840 affected·Aug 12, 2025
CriticalFDA
Max Mobility Llc
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assi...
Medical Devices·15,834 affected·Aug 12, 2025
High RiskFDA
Agilent Technologies Denmark Aps
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Vers...
Medical Devices·4,145 affected·Aug 11, 2025
High RiskFDA
Agilent Technologies Denmark Aps
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Ver...
Medical Devices·67 affected·Aug 11, 2025
High RiskFDA
Agilent Technologies Denmark Aps
Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Ve...
Medical Devices·65 affected·Aug 11, 2025
High RiskFDA
Baxter Healthcare Corporation
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code ...
Medical Devices·14,400 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 11B, Software Version: 12.0.0.932. 2. RayStation 11B Service Pac...
Medical Devices·6 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1,...
Medical Devices·2 affected·Aug 8, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
IntelliSpace Cardiovascular, Software 8.0.0.4.
Medical Devices·4 affected·Aug 8, 2025
High RiskFDA
Schiller, Ag
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
Medical Devices·266 affected·Aug 8, 2025
CriticalFDA
Medline Industries, Lp
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Medical Devices·88 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 11A, Software Version: 11.0.0.951. 2. RayStation 11A Service Pac...
Medical Devices·3 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 9B, Software Version: 9.1.0.933. 2. RayStation 9B Service Pack 1...
Medical Devices·26 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2. RayStation 6 Ser...
Medical Devices·0 affected·Aug 8, 2025
CriticalFDA
Medline Industries, Lp
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
Medical Devices·22 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pac...
Medical Devices·3 affected·Aug 8, 2025
High RiskFDA
Raysearch Laboratories Ab
RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pa...
Medical Devices·13 affected·Aug 8, 2025
High RiskFDA
Icu Medical Inc.
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
Medical Devices·29,811 affected·Aug 6, 2025
High RiskFDA
Maquet Cardiovascular, Llc
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) S...
Medical Devices·98 affected·Aug 6, 2025