Open, ClassifiedPosted Oct 25, 2024·Initiated Sep 24, 2024
Quest Spectrum 3 Fluorescent Imaging System
Model/Catalog Number: ART-SYS-0029, ART-SYS-0030
The Quest Spectrum3 is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic and reconstructive surgeries.
Reason: Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2.
Electromagnetic interference occurring during a procedure may cause the device to malfunction requiring the replacement of the device. This could potentially result in a prolonged procedure and/or require additional medical intervention
Root cause: Component design/selection
Recalling firm: Olympus Corporation of the AmericasType: Confocal Optical ImagingDistribution: OHRecall #Z-0232-2025
Open, ClassifiedPosted Oct 24, 2024·Initiated Aug 30, 2024
Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
Reason: Predict+ is being recalled for lack of pre-market clearance/approval.
Root cause: No Marketing Application
Recalling firm: Blue OrthoDistribution: US Nationwide distribution.Recall #Z-0209-2025
Open, ClassifiedPosted Oct 24, 2024·Initiated Sep 19, 2024
Baxter Operating table TruSystem 7000 U (MB), Product codes:
a) REF 1604786;
b) REF 1604788;
c) REF 1723633
Reason: The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Table, Operating-Room, ElectricalDistribution: Worldwide distribution.Recall #Z-0210-2025
Open, ClassifiedPosted Oct 24, 2024·Initiated Sep 19, 2024
Baxter Operating Table TruSystem 7000, Product code REF 1841046
Reason: The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Table, Surgical With Orthopedic Accessories, Ac-PoweredDistribution: Worldwide distribution.Recall #Z-0211-2025
Open, ClassifiedPosted Oct 24, 2024·Initiated Sep 19, 2024
Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048
Reason: The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Table, Surgical With Orthopedic Accessories, Ac-PoweredDistribution: Worldwide distribution.Recall #Z-0212-2025
Open, ClassifiedPosted Oct 24, 2024·Initiated Sep 19, 2024
Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049
Reason: The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Table, Surgical With Orthopedic Accessories, Ac-PoweredDistribution: Worldwide distribution.Recall #Z-0213-2025
Open, ClassifiedPosted Oct 24, 2024·Initiated Sep 19, 2024
Baxter Operating Table TruSystem 7000 V, Product code REF 1841050
Reason: The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Table, Surgical With Orthopedic Accessories, Ac-PoweredDistribution: Worldwide distribution.Recall #Z-0214-2025
Open, ClassifiedPosted Oct 24, 2024·Initiated Sep 19, 2024
Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082
Reason: The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Table, Surgical With Orthopedic Accessories, Ac-PoweredDistribution: Worldwide distribution.Recall #Z-0215-2025
Open, ClassifiedPosted Oct 24, 2024·Initiated Sep 19, 2024
Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
Reason: The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Table, Surgical With Orthopedic Accessories, Ac-PoweredDistribution: Worldwide distribution.Recall #Z-0216-2025
Open, ClassifiedPosted Oct 24, 2024·Initiated Sep 19, 2024
Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385
Reason: The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Table, Surgical With Orthopedic Accessories, Ac-PoweredDistribution: Worldwide distribution.Recall #Z-0217-2025
Open, ClassifiedPosted Oct 24, 2024·Initiated Sep 19, 2024
Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386
Reason: The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
Root cause: Device Design
Recalling firm: Baxter Healthcare CorporationType: Table, Surgical With Orthopedic Accessories, Ac-PoweredDistribution: Worldwide distribution.Recall #Z-0218-2025
CompletedPosted Oct 24, 2024·Initiated Sep 19, 2024
AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode
Reason: Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.
Root cause: Employee error
Recalling firm: Ad-Tech Medical Instrument CorporationType: Electrode, DepthDistribution: US Nationwide distribution in the states of CA, OH.Recall #Z-0219-2025
CompletedPosted Oct 24, 2024·Initiated Sep 19, 2024
AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode
Reason: Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.
Root cause: Employee error
Recalling firm: Ad-Tech Medical Instrument CorporationType: Electrode, DepthDistribution: US Nationwide distribution in the states of CA, OH.Recall #Z-0220-2025
CompletedPosted Oct 24, 2024·Initiated Sep 19, 2024
AD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style) Depth Electrode
Reason: Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symbol was incorrectly placed instead of the MR Unsafe symbol. The A style contacts were not cleared for MR Conditional use. Our records indicate you have received one or more of the affected lots listed above.
Root cause: Employee error
Recalling firm: Ad-Tech Medical Instrument CorporationType: Electrode, DepthDistribution: US Nationwide distribution in the states of CA, OH.Recall #Z-0221-2025
CompletedPosted Oct 24, 2024·Initiated Sep 18, 2024
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.
Reason: The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test results as components within each lot number are meant to be used together, and not mixed between lots. Therefore, the test results may possibly lead to Hemoglobin A1C positive or negative bias results. While the product is for monitoring only, over recovery with a higher than accurate value can be an indication for increased therapy; such as physical activity, weight reduction, meal management, pharmaceutical therapy.
Root cause: Under Investigation by firm
Recalling firm: Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.Type: Assay, Glycosylated HemoglobinDistribution: Worldwide distribution - US Nationwide and the countries of Japan, South Africa.Recall #Z-0223-2025
CompletedPosted Oct 24, 2024·Initiated Mar 13, 2023
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
Reason: The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
Root cause: Component design/selection
Recalling firm: Spectrum Medical Ltd.Type: Console, Heart-Lung Machine, Cardiopulmonary BypassDistribution: US Nationwide distribution including in the states of Alabama, California, Florida, Kentucky, Maine, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, West Virginia.Recall #Z-0224-2025
Open, ClassifiedPosted Oct 23, 2024·Initiated Jul 18, 2024
smiths medical portex, Nasopharyngeal Airway, Sizes as follows:
a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060;
b) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060JP;
c) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070;
d) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070JP;
e) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080;
f) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080JP;
g) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080JS;
h) AIRWAY NASOPHARYNGEAL 9.0MM, REF 100/210/090;
i) AIRWAY NASOPHARYNGEAL 9.0MM, REF 100/210/090JP;
Reason: Uncertainty in the seal integrity of the sterile packaging.
Root cause: Packaging process control
Recalling firm: Smiths Medical ASD Inc.Type: Airway, NasopharyngealDistribution: Worldwide distribution.Recall #Z-0143-2025
Open, ClassifiedPosted Oct 23, 2024·Initiated Jul 18, 2024
smiths medical portex, 15mm Double Swivel Connector:
a) REF 100/255/150;
b) REF 100/255/150JP;
c) REF 100/255/150 JS
Reason: Uncertainty in the seal integrity of the sterile packaging.
Root cause: Packaging process control
Recalling firm: Smiths Medical ASD Inc.Type: Connector, Airway (Extension)Distribution: Worldwide distribution.Recall #Z-0144-2025
Open, ClassifiedPosted Oct 23, 2024·Initiated Jul 18, 2024
smiths medical portex, Y' PIECE 15MM, REF 100/276/000
Reason: Uncertainty in the seal integrity of the sterile packaging.
Root cause: Packaging process control
Recalling firm: Smiths Medical ASD Inc.Type: Condenser, Heat And Moisture (Artificial Nose)Distribution: Worldwide distribution.Recall #Z-0145-2025
Open, ClassifiedPosted Oct 23, 2024·Initiated Jul 18, 2024
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Reason: Uncertainty in the seal integrity of the sterile packaging.
Root cause: Packaging process control
Recalling firm: Smiths Medical ASD Inc.Type: Condenser, Heat And Moisture (Artificial Nose)Distribution: Worldwide distribution.Recall #Z-0146-2025