Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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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…
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Class II · 7 months ago
I.T.S. GmbH Distal Humeral Plates 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 II · 7 months ago
I.T.S. GmbH HLS - Hand Locking Plates System with the below descriptions 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
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS 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 II · 7 months ago
I.T.S. GmbH I.T.S. Screw System with the below descriptions and corresponding 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 III · 7 months ago
Philips S5-2 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 Olecranonplate with Angular Stability with the below descriptions 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 w/ oversheath REF: 20402-401 Sterile EO recall: Probes may rupture/burst during activation
Probes may rupture/burst during activation
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Class II · 7 months ago
I.T.S. GmbH FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking 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
Philips Respironics Trilogy EV300, 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 I · 7 months ago
Philips Respironics Trilogy Evo Universal 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
I.T.S. GmbH HCS - Headless Compression Screw System, Headless Compression Screw 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
Orthalign, Inc Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 recall: Drill plates manufactured out of specification can result in a bone cut
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)