Medical DeviceMay 20, 2020
Cardiac Assist TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product recall — FDA Z-1951-2020
Failure to prime due to an assembly error
Class IIFDA: TerminatedCardiac Assist, Inc.
May 2020 recalls — page 6
These records include useful source details for the selected month.
Medical DeviceMay 20, 2020
Merit Medical Systems Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended recall — FDA Z-1956-2020
labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging.…
Class IIFDA: TerminatedMerit Medical Systems, Inc.
Medical DeviceMay 20, 2020
Inpeco S.A Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part recall — FDA Z-2004-2020
When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.
Class IIFDA: TerminatedInpeco S.A.
Medical DeviceMay 20, 2020
BD SWITZERLAND SARL BD Alaris PCEA Administration Set, Microbore Tubing with Yellow recall — FDA Z-1968-2020
The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health…
Class IIFDA: TerminatedBD SWITZERLAND SARL
Medical DeviceMay 20, 2020
ICU Medical Central Venous Catheters are indicated for the assessment of hemodynamic status recall — FDA Z-1996-2020
Inability for the guidewire to pass through the needles included with the catheter kits.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceMay 20, 2020
Access Scientific BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm recall — FDA Z-1975-2020
Saline Flush Syringe compromised sterility due to holes in the packaging.
Class IIFDA: TerminatedAccess Scientific LLC
Medical DeviceMay 20, 2020
Access Scientific BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit recall — FDA Z-1972-2020
Saline Flush Syringe compromised sterility due to holes in the packaging.
Class IIFDA: TerminatedAccess Scientific LLC
Medical DeviceMay 20, 2020
Covidien Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor recall — FDA Z-1987-2020
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an…
Class IIFDA: TerminatedCovidien LLC
Medical DeviceMay 20, 2020
Cuattro recall — FDA Z-1934-2020
There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.
Class IIFDA: TerminatedCuattro LLC
Medical DeviceMay 20, 2020
BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and recall — FDA Z-1964-2020
The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
Class IIFDA: OngoingBard Peripheral Vascular Inc.
Medical DeviceMay 20, 2020
Covidien Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray recall — FDA Z-1994-2020
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an…
Class IIFDA: TerminatedCovidien LLC
Medical DeviceMay 20, 2020
Access Scientific BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm recall — FDA Z-1978-2020
Saline Flush Syringe compromised sterility due to holes in the packaging.
Class IIFDA: TerminatedAccess Scientific LLC
Medical DeviceMay 20, 2020
Ortho-Clinical Diagnostics VITROS Chemistry Products CKMB Slides, Creatine Kinase MB recall — FDA Z-1930-2020
The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceMay 20, 2020
Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY recall — FDA Z-2006-2020
The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently less than…
Class IIFDA: TerminatedRa Medical Systems, Inc.
Medical DeviceMay 20, 2020
Edwards Lifesciences Oxymetry Cable, Rxonly recall — FDA Z-1928-2020
Intermittent communication due to inconsistent crimping of connectors onto cables.
Class IIFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceMay 20, 2020
Argon Medical Devices PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE recall — FDA Z-1938-2020
Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more…
Class IIFDA: TerminatedArgon Medical Devices, Inc.
Medical DeviceMay 20, 2020
The Magstim Company Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is recall — FDA Z-1965-2020
It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.
Class IIFDA: TerminatedThe Magstim Company Limited
Medical DeviceMay 20, 2020
Ortho-Clinical Diagnostics VITROS Chemistry Products CKMB Slides, Creatine Kinase MB recall — FDA Z-1931-2020
The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
Class IIFDA: TerminatedOrtho-Clinical Diagnostics
Medical DeviceMay 20, 2020
Sunrise Medical (US) Quickie/Zippie powered wheelchair recall — FDA Z-1947-2020
Due to programming errors in the Controller, an increase in the set motor parameters can be made by the end user beyond tested safe limits.
Class IIFDA: TerminatedSunrise Medical (US) LLC
Medical DeviceMay 20, 2020
Intuitive Surgical da Vinci X Surgical System recall — FDA Z-1961-2020
Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
Class IIFDA: TerminatedIntuitive Surgical, Inc.
Medical DeviceMay 20, 2020
Access Scientific BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm recall — FDA Z-1979-2020
Saline Flush Syringe compromised sterility due to holes in the packaging.
Class IIFDA: TerminatedAccess Scientific LLC
Medical DeviceMay 20, 2020
Access Scientific BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm recall — FDA Z-1982-2020
Saline Flush Syringe compromised sterility due to holes in the packaging.
Class IIFDA: TerminatedAccess Scientific LLC
Medical DeviceMay 20, 2020
Access Scientific BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate recall — FDA Z-1973-2020
Saline Flush Syringe compromised sterility due to holes in the packaging.
Class IIFDA: TerminatedAccess Scientific LLC
Medical DeviceMay 20, 2020
Covidien Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL recall — FDA Z-1990-2020
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an…
Class IIFDA: TerminatedCovidien LLC
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.