Latest recalls — page 151
Older notices, newest first.
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Class I · 7 months ago
Navajo Manufacturing Company Handy Solutions Neck & Shoulders Heating Pad recall: If heating pad is folded while in use, the power density increases
If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by…
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Class I · 7 months ago
Merit Medical Systems, Inc. BioFlo DuraMax Catheter, REF: H965103028011/A recall: 16F dual-valved splittable sheath introducer due to a design defect
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies…
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Class III · 7 months ago
Philips L17-5 Ultrasound Transducer recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class II · 7 months ago
I.T.S. GmbH I.T.S. LRS with the below descriptions and corresponding article recall: Updated MRI safety testing demonstrates higher RF-induced temperature
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the…
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Class II · 7 months ago
Olympus Endoscope Reprocessor OER-Elite recall: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
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Class II · 7 months ago
Tandem pumps are battery-operated infusion pumps capable of both basal recall: The Czech language user guide contained multiple translation errors. The most
The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify…
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Class I · 7 months ago
Merit Medical Systems, Inc. 16F Dual Valved Splittable Sheath Introducer recall: 16F dual-valved splittable sheath introducer due to a design defect
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies…
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Class II · 7 months ago
Waldemar Link GmbH & Co. KG Embrace Drill Tower, Wedged recall: The surgical technique for the Embrace Shoulder Instruments - Drill Tower has
The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However…
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Class II · 7 months ago
Medtronic MiniMed, Inc. MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 recall: Three software defects (Pump Error 53, BG check
Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions…
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Class II · 7 months ago
Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK recall: Olympus identified that the Cutting Forceps contain components
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective…
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Class III · 7 months ago
Philips OMNI II TEE Ultrasound Transducer recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class III · 7 months ago
Philips X3-1 Ultrasound Transducer recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class II · 7 months ago
CareFusion 303, Inc. BD Alaris" System with Guardrails" Suite MX with Point of Care recall: Due to product labeling not indicating which Transport Layer Security (TLS)
Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi…
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Class II · 7 months ago
Olympus Endoscope Reprocessor OER-Pro recall: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
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Class I · 7 months ago
Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00 recall: Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume…
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Class II · 7 months ago
GE Medical Systems, LLC Imactis CT-Navigation System recall: There is a potential issue that can lead to discordance between the simulated
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip…
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Class III · 7 months ago
Philips S4-1 Ultrasound Transducer recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class II · 7 months ago
Brand Name: Olympus PKS Cutting Forceps w/Cord recall: Olympus identified that the Cutting Forceps contain components
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective…
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Class I · 7 months ago
Merit Medical Systems, Inc. ProGuide Chronic Dialysis Catheters, REF: DC01455550/C recall: 16F dual-valved splittable sheath introducer due to a design defect
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies…
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Class II · 7 months ago
Olympus Endoscope Suction Valve - MAJ-1443 recall: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
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Class II · 7 months ago
I.T.S. GmbH Brand Name: I.T.S. Pelvic Reconstruction System with the below recall: Updated MRI safety testing demonstrates higher RF-induced temperature
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the…
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Class II · 7 months ago
I.T.S. GmbH I.T.S. Straight Plate with Angular Stability with the below recall: Updated MRI safety testing demonstrates higher RF-induced temperature
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the…
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Class I · 7 months ago
Erbe USA Inc Flexible Cryoprobe REF: 20402-411. For surgical use recall: Probes may rupture/burst during activation
Probes may rupture/burst during activation
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Class I · 7 months ago
Merit Medical Systems, Inc. CentrosFLO Hemodialysis Catheters, REF: Cenfp15K/A recall: 16F dual-valved splittable sheath introducer due to a design defect
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies…