Medical DeviceAug 21, 2019
BioPro K-Wire HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the BioPro recall — FDA Z-2259-2019
Manufacturing flaw in the sterile barrier system
Class IIFDA: TerminatedBioPro, Inc.
Monthly breakdown
2019 recalls by month
Select a month to review the recall records reported during that period.
December 2019321 records · 4 categoriesNovember 2019597 records · 4 categoriesOctober 2019525 records · 4 categoriesSeptember 2019268 records · 4 categoriesAugust 2019505 records · 4 categoriesJuly 2019680 records · 4 categoriesJune 2019445 records · 4 categoriesMay 2019396 records · 4 categoriesApril 2019242 records · 4 categoriesMarch 2019250 records · 4 categoriesFebruary 2019381 records · 4 categoriesJanuary 2019142 records · 4 categories
2019 recalls — page 77
Records are ordered by the best available source date.
Medical DeviceAug 21, 2019
Luminex Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452 recall — FDA Z-2282-2019
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
Luminex ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469 recall — FDA Z-2286-2019
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
Degania Silicone Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar recall — FDA Z-2262-2019
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 6.5x105, Item Number 19669 - Product Usage: Accessories to the BioPro recall — FDA Z-2255-2019
Manufacturing flaw in the sterile barrier system
Class IIFDA: TerminatedBioPro, Inc.
Medical DeviceAug 21, 2019
Luminex ARIES GBS Assay , REF 50-10021, UDI # 00840487100165 recall — FDA Z-2285-2019
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 6.5x32, Item Number 19652 - Product Usage: Accessories to the BioPro recall — FDA Z-2254-2019
Manufacturing flaw in the sterile barrier system
Class IIFDA: TerminatedBioPro, Inc.
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.
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.
About the 2019 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.