Latest recalls — page 198
Older notices, newest first.
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Class II · 10 months ago
Securitas Healthcare LLC Arial 900 MHz Call Station recall: Securitas Healthcare has become aware of a firmware issue in the Call
Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots…
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Class II · 10 months ago
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor recall: It was found that the MX40 device could not reconnect to the PIC iX
It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal…
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Class II · 10 months ago
Abiomed, Inc. Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set recall: Device packaged in incorrect outer box carton
Device packaged in incorrect outer box carton.
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Class II · 10 months ago
Roche Diagnostics Operations, Inc. The Elecsys Anti-Tshr immunoassay is a three-step recall: Issues identified: 1) Results vary by Instrument Platform
Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis…
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Class I · 10 months ago
AVID Medical, Inc. Halyard Mini Plus KIT South, Kit Code: Jack097-08 recall: Devices are not suitable for organ transplant
Devices are not suitable for organ transplant.
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Class II · 10 months ago
Siemens Medical Solutions USA, Inc Luminos Lotus Max recall: A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max
A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors…
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Class II · 10 months ago
Remote Diagnostic Technologies Ltd. Philips Tempus Pro recall: Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure
Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for…
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Class II · 10 months ago
Meridian Bioscience Inc Revogene C. difficile, in vitro diagnostic assay intended recall: The affected lots show a decline in performance over time
The affected lots show a decline in performance over time, which may lead to false-negative results.
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Class II · 10 months ago
IMRIS Imaging Inc Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/ recall: Torque screw may crack or separate. If used
Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision…
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Class I · 10 months ago
AVID Medical, Inc. Halyard Organ Recovery OR Pack, Kit Code: Llog1000-15 recall: Devices are not suitable for organ transplant
Devices are not suitable for organ transplant.
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Class I · 10 months ago
AVID Medical, Inc. Halyard Organ Recovery OR Pack, Kit Code: Llof1000-17 recall: Devices are not suitable for organ transplant
Devices are not suitable for organ transplant.
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Class II · 10 months ago
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456 recall: Beckman Coulter has determined that, due to a potential communication issue
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a…
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Class II · 10 months ago
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260 recall: Beckman Coulter has determined that, due to a potential communication issue
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a…
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Class II · 10 months ago
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE recall: Firm received multiple complaints regarding tubing disconnecting from oxygen
Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and…
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Class II · 10 months ago
Applied Medical Resources Corp Kii Low Profile, Bladed Dual Pack recall: There is the potential for extended length of the blade obturator after
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
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Class II · 10 months ago
Sophysa The Pressio 2 ICP Monitoring System recall: Customer complaints of Pressio monitor rebooting
Customer complaints of Pressio monitor rebooting.
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Class II · 10 months ago
CareFusion 303, Inc. BD Pyxis ES Enterprise Server Catalog Numbers 1115-00 recall: Due a software issue that may result in equipment not receiving timely
Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
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Class II · 10 months ago
Philips Incisive CT recall: Potential for incomplete scan due to unstable connection inside of floating
Potential for incomplete scan due to unstable connection inside of floating sensor.
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Class II · 10 months ago
Integra LifeSciences Corp. Codman Microsensor Basic Kit recall: Potential corrosion stains on the surface of the 14-gauge Tuohy Needle
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.
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Class II · 10 months ago
Vision RT Ltd The AlignRT InBore system contains six Class 1 lasers which enables recall: Vision RT is informing customers of an omission identified
Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers…
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Class II · 10 months ago
Imprimis NJOF, LLC Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL recall: Presence of particulate matter - Glass like particles
Presence of particulate matter - Glass like particles.
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Class II · 10 months ago
Imprimis NJOF, LLC Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL recall: Presence of particulate matter - Glass like particles
Presence of particulate matter - Glass like particles.
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Class III · 10 months ago
Alembic Pharmaceuticals Limited Fesoterodine Fumarate, Extended-release Tablets recall: Failed Impurities/Degradation Specifications: Due to levels of 'Diester
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
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Class II · 10 months ago
AvKARE Rosuvastatin Tablets, USP, 10 mg recall: Out of specification for dissolution
Out of specification for dissolution.