Medical DeviceOct 10, 2018
Stryker Neurovascular AXS Infinity LS Long Sheath:( recall — FDA Z-3281-2018
The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
Class IIFDA: TerminatedStryker Neurovascular
Latest records
Latest recalls — page 1348
The newest recall records with useful source details are listed here.
Medical DeviceOct 10, 2018
B. Braun Medical EC20O 20G X 100CM CATH OPEN TIP LF, Material Number 333520 Connection recall — FDA Z-3399-2018
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceOct 10, 2018
B. Braun Medical CNB200TK CONTIPLEX CONT NERVE BLOCK, Material Number 331701 Connection recall — FDA Z-3323-2018
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceOct 10, 2018
B. Braun Medical CONT STIM BASIC KIT W/2 IN INSUL TUOHY, Material Number 331757 Connection recall — FDA Z-3326-2018
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceOct 10, 2018
ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The recall — FDA Z-0069-2019
Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the…
Class IIFDA: CompletedICU Medical, Inc.
Medical DeviceOct 10, 2018
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx recall — FDA Z-0011-2019
Sterility failure found in one of the units in the lot.
Class IIFDA: TerminatedEllex iScience, Inc.
Medical DeviceOct 10, 2018
Oridion Medical 1987 Capnostream20 M NICU (CPM), CS08654RN recall — FDA Z-0046-2019
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Class IIFDA: TerminatedOridion Medical 1987 Ltd.
Medical DeviceOct 10, 2018
B. Braun Medical CE18TKY 18GA SAFETY TUOHY NEEDLE TRAY, Material Number 332266 Connection recall — FDA Z-3378-2018
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceOct 10, 2018
B. Braun Medical CEP18TKO CONT. EPIDURAL PEDIATRIC KIT, Material Number 332290 Connection recall — FDA Z-3382-2018
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceOct 10, 2018
Oridion Medical 1987 Capnostream20 (INTL) N REFURBISHED, CS78652 recall — FDA Z-0051-2019
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Class IIFDA: TerminatedOridion Medical 1987 Ltd.
Medical DeviceOct 10, 2018
Oridion Medical 1987 Capnostream20 (INTL) M, CS08654 recall — FDA Z-0044-2019
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Class IIFDA: TerminatedOridion Medical 1987 Ltd.
Medical DeviceOct 10, 2018
Johnson & Johnson Surgical Vision OptiMedica Catalys Precision Laser System, CE 0044 recall — FDA Z-0066-2019
Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the…
Class IIFDA: TerminatedJohnson & Johnson Surgical Vision Inc.
Medical DeviceOct 10, 2018
B. Braun Medical CE17TKCDLS CONT EPIDURAL TRAY, Material Number 332212 Connection device recall — FDA Z-3357-2018
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceOct 10, 2018
B. Braun Medical CE18TKDP CONT EPID/DURAPREP, Material Number 332215 Connection device used recall — FDA Z-3358-2018
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceOct 10, 2018
Varian Medical Systems VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The recall — FDA Z-0005-2019
Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is…
Class IIFDA: TerminatedVarian Medical Systems
Medical DeviceOct 10, 2018
B. Braun Medical ES1827QK ESPOCAN COMBINED 27GA, Material Number 333182 Connection device recall — FDA Z-3390-2018
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceOct 10, 2018
Oridion Medical 1987 CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658 recall — FDA Z-0040-2019
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Class IIFDA: TerminatedOridion Medical 1987 Ltd.
Medical DeviceOct 10, 2018
ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Proximal recall — FDA Z-0008-2019
Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device. This is a…
Class IFDA: TerminatedEndologix
Medical DeviceOct 10, 2018
B. Braun Medical CE17TKFCY 17GA SAFETY TUOHY NEEDLE TRAY, Material Number 332075 Connection recall — FDA Z-3330-2018
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceOct 10, 2018
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring recall — FDA Z-0075-2019
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Class IIIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceOct 10, 2018
smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm recall — FDA Z-0071-2019
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Class IIIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceOct 10, 2018
B. Braun Medical CE17TKFSDT EPID TRAY W/17GA FIXED WING, Material Number 332093 Connection recall — FDA Z-3340-2018
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceOct 10, 2018
B. Braun Medical CCE18HK10L CONT EPIDURAL TRAY, Material Number 332264 Connection device recall — FDA Z-3377-2018
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceOct 10, 2018
Oridion Medical 1987 Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657 recall — FDA Z-0034-2019
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Class IIFDA: TerminatedOridion Medical 1987 Ltd.
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