Latest recalls — page 62
Older notices, newest first.
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Class II · 3 months ago
Olympus Toomey Evacuator 50cc with Adaptor recall: Some sterilization parameters included in the IFU may not consistently render
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used…
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Class II · 3 months ago
Orthofix Minirail, Short, Lengthener REF: M103 recall: Unilateral external fixation devices may be incorrectly labeled. Minirail
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail…
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Class II · 3 months ago
GE Medical Systems, LLC Optima XR240amx, Mobile Digital Radiographic System recall: GE HealthCare has become aware that in certain Optima XR200/220/240amx
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of…
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Class II · 3 months ago
Maquet Cardiovascular, LLC The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System recall: Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma…
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Class I · 3 months ago
Abiomed Impella 5.5 SmartAssist S2 Set, JP recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class I · 3 months ago
Argon Medical Devices, Inc T-Lok Bone Marrow Tray, REF: BMT1104STL recall: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for…
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Class II · 3 months ago
Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115 recall: Medtronic received two complaints of loose foreign material confirmed
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
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Class I · 3 months ago
Abiomed Impella CP Introducer Kit 14 Fr, 25 cm recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class II · 3 months ago
Orthofix Minirail, Articulated, Fixator, Vertical Axis REF: M122 recall: Unilateral external fixation devices may be incorrectly labeled. Minirail
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail…
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Class I · 3 months ago
Abiomed Impella CP Set, Pump Set Code 0048-0014 recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class II · 3 months ago
Medline Kits containing Zimmer Biomet mixing bowls and spatulas Total recall: Kits contain Zimmer Biomet mixing bowls and spatulas
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health…
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Class II · 3 months ago
Orthofix Articulated Minirail Fixator Horizontal Axis REF: M111 recall: Unilateral external fixation devices may be incorrectly labeled. Minirail
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail…
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Class I · 3 months ago
Argon Medical Devices, Inc One-Piece Introducer Tray, REF: 497455 recall: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for…
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Class II · 3 months ago
ICU Medical Plum Solo Precision IV Pump, v1.0.3 recall: In a specific scenario, the pump will not decrement the Volume to be Infused
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the…
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Class I · 3 months ago
Oscor Inc. Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away recall: Due to manufacturing issues, there is a potential for the 14Fr and 23Fr
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along…
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Class I · 3 months ago
Argon Medical Devices, Inc Transvenous Pacing Electrode Tray w/ Bipolar Balloon recall: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for…
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Class I · 3 months ago
Abiomed Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP recall: A potential for introducer sheath leakage from under the sheath cap and along
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These…
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Class II · 3 months ago
Daavlin Distributing Company Photera 600, phototherapy device recall: Calibrated Output was not calculating correctly - UV Sensor GAIN being
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at…
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Class I · 3 months ago
Argon Medical Devices, Inc Arterial Line Kit 20ga x 6, REF: 400115A recall: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for…
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Class II · 3 months ago
Olympus Glass Body for 194 Ellik Evacuator recall: Some sterilization parameters included in the IFU may not consistently render
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used…
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Class II · 3 months ago
Olympus Toomey Evacuator 30cc with Adaptor recall: Some sterilization parameters included in the IFU may not consistently render
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used…
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Class II · 3 months ago
Tosoh Bioscience Inc ST Aia-Pack Testosterone, IN Vitro Diagnostic USE Only recall: The Test cup lot F level 1 low-quality control results values for the device
The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA)…
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Class I · 3 months ago
Argon Medical Devices, Inc General Biospy Tray, REF: GUTS1000 recall: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for…
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Class II · 3 months ago
GE Medical Systems, LLC Optima XR220amx, Mobile Digital-Ready Radiographic System recall: GE HealthCare has become aware that in certain Optima XR200/220/240amx
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of…