Medical DeviceMar 24, 2021
Cordis PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC recall — FDA Z-1257-2021
Distal tip may become separated from the lumen wire in specific lots.
Class IFDA: CompletedCordis Corporation
Latest records
Latest recalls — page 891
The newest recall records with useful source details are listed here.
Medical DeviceMar 24, 2021
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B recall — FDA Z-1269-2021
System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
Class IIFDA: OngoingCanon Medical System, USA, Inc.
Medical DeviceMar 24, 2021
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization Table CAT-880B recall — FDA Z-1270-2021
System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
Class IIFDA: OngoingCanon Medical System, USA, Inc.
Medical DeviceMar 24, 2021
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B recall — FDA Z-1271-2021
System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
Class IIFDA: OngoingCanon Medical System, USA, Inc.
Medical DeviceMar 24, 2021
Merit Medical Systems HeartSpan Transseptal Needles Catalog No recall — FDA Z-1262-2021
The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an…
Class IIFDA: TerminatedMerit Medical Systems, Inc.
Medical DeviceMar 24, 2021
R & D Systems Quantikine IVD Human sTfR Immunoassay recall — FDA Z-1255-2021
R&D Systems, Inc. received two complaints that the standard signal was low and controls were not within the specification range provided with the kit. Investigation confirmed low standard…
Class IIFDA: TerminatedR & D Systems, Inc.
Medical DeviceMar 24, 2021
Philips Incisive CT Computed Tomography X-ray System Model: 728143 recall — FDA Z-1265-2021
Actuators in the Incisive gantry could result in the gantry failure to self-lock if both of the 2 sides actuators fail. In some cases in systems with affected components, the gantry may…
Class IIFDA: TerminatedPhilips North America LLC
Medical DeviceMar 24, 2021
Imactis Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # recall — FDA Z-1264-2021
Defect in the mechanical assembly of the needle holder contained in the navigation kit. One of the 2 jaws of the needle holder does not provide gripping functionality; if the defect is not…
Class IIFDA: TerminatedImactis
Medical DeviceMar 24, 2021
Siemens Medical Solutions USA Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in recall — FDA Z-1253-2021
SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in sporadic problems causing scanning workflow interruptions and unexpected user notifications.…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMar 24, 2021
Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B) recall — FDA Z-1194-2021
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Class IFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceMar 24, 2021
Philips CT systems are advanced continuous-rotation computed tomography systems suitable for recall — FDA Z-1273-2021
Philips has internally detected an issue with the actuators used in the Incisive CT couch, which could result in the couch failure to self-lock, and unexpectedly moving slowly downward to…
Class IIFDA: TerminatedPhilips Healthcare (Suzhou) Co., Ltd.
Medical DeviceMar 24, 2021
Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with recall — FDA Z-1190-2021
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Class IFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceMar 24, 2021
Medtronic Perfusion Systems Custom Perfusion System recall — FDA Z-1196-2021
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Class IFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceMar 24, 2021
Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n recall — FDA Z-1254-2021
BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation resumes. If a freeze occur, patients monitored on a telemetry transmitter will no longer…
Class IIFDA: OngoingMindray DS USA, Inc. dba Mindray North America
Medical DeviceMar 24, 2021
Cardinal Health 200 Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm) recall — FDA Z-1250-2021
Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to…
Class IIFDA: TerminatedCardinal Health 200, LLC
Medical DeviceMar 24, 2021
Merit Medical Systems Heartspan Transseptal Needles, Catalog No recall — FDA Z-1263-2021
The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip curvature. In the event that the incorrect needle is unknowingly used, an…
Class IIFDA: TerminatedMerit Medical Systems, Inc.
Medical DeviceMar 24, 2021
Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with recall — FDA Z-1191-2021
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Class IFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceMar 24, 2021
Medtronic Custom Perfusion Pack recall — FDA Z-1195-2021
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Class IFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceMar 24, 2021
Medtronic Perfusion Systems Custom Perfusion System recall — FDA Z-1199-2021
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Class IFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceMar 24, 2021
Medtronic Perfusion Systems Custom Perfusion System recall — FDA Z-1192-2021
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Class IFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceMar 24, 2021
Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B) recall — FDA Z-1197-2021
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Class IFDA: TerminatedMedtronic Perfusion Systems
Medical DeviceMar 24, 2021
Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage recall — FDA Z-1268-2021
The mirror may become detached and fall from the unit
Class IIFDA: TerminatedCARESTREAM DENTAL, LLC
Medical DeviceMar 24, 2021
Siemens Healthcare Diagnostics Enzyme linked immunosorbent assay, for herpes simplex virus recall — FDA Z-1274-2021
Potential false positive HSV results. Siemens Healthcare Diagnostics, Inc. initiated a correction for ADVIA Centaur4P Herpes-2 lgG (HSV2) Onboard Stability and Calibration Frequency…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMar 24, 2021
Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B) recall — FDA Z-1198-2021
Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.
Class IFDA: TerminatedMedtronic Perfusion Systems
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Recent recall archives
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October 2026111 records · 4 categoriesSeptember 2026364 records · 4 categoriesAugust 2026302 records · 4 categoriesJuly 2026370 records · 4 categoriesJune 2026376 records · 4 categoriesMay 2026340 records · 4 categoriesApril 2026415 records · 4 categoriesMarch 2026190 records · 4 categoriesFebruary 2026331 records · 4 categoriesJanuary 2026212 records · 4 categoriesDecember 2025389 records · 4 categoriesNovember 2025326 records · 4 categories