Medical DeviceAug 21, 2019
BioPro Go-EZ Screw 6.5x36, Item Number 19654 - Product Usage: Accessories to the BioPro recall — FDA Z-2248-2019
Manufacturing flaw in the sterile barrier system
Class IIFDA: TerminatedBioPro, Inc.
August 2019 recalls — page 6
These records include useful source details for the selected month.
Medical DeviceAug 21, 2019
BioPro K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accessories to recall — FDA Z-2242-2019
Manufacturing flaw in the sterile barrier system
Class IIFDA: TerminatedBioPro, Inc.
Medical DeviceAug 21, 2019
Luminex ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158 recall — FDA Z-2284-2019
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed…
Class IIFDA: OngoingLuminex Corporation
Medical DeviceAug 21, 2019
Siemens Medical Solutions USA SOMATOM Definition Flash, Model Number 10430603 - Product recall — FDA Z-2270-2019
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceAug 21, 2019
Luminex ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059 recall — FDA Z-2287-2019
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed…
Class IIFDA: OngoingLuminex Corporation
Medical DeviceAug 21, 2019
BioPro Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the BioPro recall — FDA Z-2247-2019
Manufacturing flaw in the sterile barrier system
Class IIFDA: TerminatedBioPro, Inc.
Medical DeviceAug 21, 2019
Degania Silicone Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN recall — FDA Z-2267-2019
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical…
Class IIFDA: TerminatedDegania Silicone, Ltd.
Medical DeviceAug 21, 2019
BioPro Go-EZ Screw 6.5x30, Item Number 19651 - Product Usage: Accessories to the BioPro recall — FDA Z-2246-2019
Manufacturing flaw in the sterile barrier system
Class IIFDA: TerminatedBioPro, Inc.
Medical DeviceAug 21, 2019
Siemens Medical Solutions USA SOMATOM Definition Edge, Model Number 10590000 - Product recall — FDA Z-2269-2019
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceAug 21, 2019
Degania Silicone Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An recall — FDA Z-2260-2019
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical…
Class IIFDA: TerminatedDegania Silicone, Ltd.
Medical DeviceAug 21, 2019
Luminex ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295 recall — FDA Z-2283-2019
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed…
Class IIFDA: OngoingLuminex Corporation
Medical DeviceAug 21, 2019
Fenwal VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a recall — FDA Z-2064-2019
The firm is correcting four software anomalies and KVO (keep vein open) end of infusion alarm priority in Software versions 1.7 and 1.9a of Volumat MC Agilia Software and versions 1.0 and…
Class IFDA: TerminatedFenwal Inc.
Medical DeviceAug 21, 2019
Medline Primary Warmer Pack, Product No recall — FDA Z-2066-2019
The Vyaire enFlow disposable cartridge was recalled due to the potential for unsafe aluminum levels to elute into the infusate. The Use of the BD Alaris Pump Infusion Set may lead to…
Class IFDA: TerminatedMedline Industries Inc.
Medical DeviceAug 21, 2019
Canadian Hospital Specialties MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF recall — FDA Z-2281-2019
The firm received a complaint that the connector detached from the feeding tube.
Class IIFDA: TerminatedCanadian Hospital Specialties
Medical DeviceAug 21, 2019
Siemens Medical Solutions USA SOMATOM Edge Plus, Model Number 10267000 - Product Usage recall — FDA Z-2273-2019
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceAug 21, 2019
Medline Industries Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets recall — FDA Z-2067-2019
This recall is a sub recall to BD s recent Class I recall for the Alaris Pump Infusion Set due to an issue with the consistency of the inner lumen thickness of the silicone tubing segment…
Class IFDA: TerminatedMedline Industries Inc.
Medical DeviceAug 21, 2019
BioPro K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro recall — FDA Z-2239-2019
Manufacturing flaw in the sterile barrier system
Class IIFDA: TerminatedBioPro, Inc.
Medical DeviceAug 21, 2019
NeuroLogica HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03 recall — FDA Z-2275-2019
There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode.
Class IIFDA: TerminatedNeuroLogica Corporation
Medical DeviceAug 21, 2019
BioPro K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Accessories to recall — FDA Z-2241-2019
Manufacturing flaw in the sterile barrier system
Class IIFDA: TerminatedBioPro, Inc.
Medical DeviceAug 21, 2019
BioPro K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - Product Usage: Accessories to recall — FDA Z-2243-2019
Manufacturing flaw in the sterile barrier system
Class IIFDA: TerminatedBioPro, Inc.
Medical DeviceAug 21, 2019
NeuroLogica WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19 recall — FDA Z-2276-2019
There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size value set by the user in the Doppler Only mode.
Class IIFDA: TerminatedNeuroLogica Corporation
Medical DeviceAug 21, 2019
Siemens Medical Solutions USA SOMATOM Force, Model Number 10742326 - Product Usage: Computed recall — FDA Z-2274-2019
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceAug 21, 2019
BioPro Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the BioPro recall — FDA Z-2258-2019
Manufacturing flaw in the sterile barrier system
Class IIFDA: TerminatedBioPro, Inc.
Medical DeviceAug 21, 2019
Siemens Medical Solutions USA SOMATOM Drive, Model Number 10431700 - Product Usage: Computed recall — FDA Z-2271-2019
Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.