Medical Device Recalls

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7,979 medical device recalls from federal enforcement feeds.

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Showing 6,851–6,900 of 7,979

Medical Device Recall · March 12, 2024
Philips North America Llc
Intera 1.5T Achieva IT Nova, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Ingenia 1.5T CX, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Intera 1.0T Omni/Stellar, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Intera 0.5T Standard, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Achieva 3.0T for PET, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
GYROSCAN T10-NT, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Ingenia Ambition S, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
SmartPath to dStream for 1.5T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Ingenia Ambition X, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Ingenia Elition S, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Intera 1.5T Omni/Stellar, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Achieva 3.0T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
MR 5300, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Intera 1.5T Power/Pulsar, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
DePuy Orthopaedics, Inc.
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Product incorrectly labelled.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
MR 7700, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
GYROSCAN T5, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Intera 1.5T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Intera Achieva 1.5T Pulsar, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Intera CV, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Achieva 1.5T Conversion, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Achieva 1.5T Initial, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Intera 3.0T Quasar Dual, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Enterprise 1.5T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Ingenia 3.0T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
MEDLINE INDUSTRIES, LP - Northfield
namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 6008
Products have a lack of sterility assurance.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Intera 1.5T Achieva Nova, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Ingenia Elition X, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Ingenia 1.5T S, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Intera 1.5T Master/Nova, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Ingenia 1.5T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Achieva 1.5T, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Ingenia 3.0T CX, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
GYROSCAN T5-NT, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
MEDLINE INDUSTRIES, LP - Northfield
Namic FLUID DELIVERY SET, REF 91300040
Products have a lack of sterility assurance.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Intera 1.5T R11, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 12, 2024
Philips North America Llc
Intera 1.0T Power/Pulsar, Magnetic Resonance System.
Patient support table floor plate may be incorrectly installed.
Class II
Medical Device Recall · March 11, 2024
Coloplast Manufacturing US, LLC
Ureteral dilator, REF RBD014
A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility.
Class II
Medical Device Recall · March 11, 2024
Baxter Healthcare Corporation
HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for hip surgery
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled incorrectly. The locking ridge on the front face of the boot key socket is facing upwards, which prevents the socket mechanism on the traction boot from attaching properly to the spar of the traction system. This will cause the boot to detach from the traction system.
Class II
Medical Device Recall · March 11, 2024
Advanced Instruments, LLC
OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and urine. Model/Catalog Number: OsmoPRO MAX So
System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls.
Class II
Medical Device Recall · March 11, 2024
Smith & Nephew Medical, Ltd.
RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Class II
Medical Device Recall · March 11, 2024
Conformis, Inc.
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
Class II
Medical Device Recall · March 11, 2024
Smith & Nephew Medical, Ltd.
RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Class II
Medical Device Recall · March 9, 2024
Noah Medical
Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for dia
Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope.
Class II
Medical Device Recall · March 8, 2024
Ethicon, Inc.
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximatio
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
Class II
Medical Device Recall · March 8, 2024
ROUTE 92 MEDICAL INC
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Class I
Medical Device Recall · March 8, 2024
ROUTE 92 MEDICAL INC
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
Class I
Medical Device Recall · March 8, 2024
ROUTE 92 MEDICAL INC
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Class I