Medical DeviceApr 22, 2020
Life Technologies Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA recall — FDA Z-1705-2020
Extended Expiration Date prior to clearance
Class IIFDA: TerminatedLife Technologies Corporation
April 2020 recalls — page 4
These records include useful source details for the selected month.
Medical DeviceApr 22, 2020
Life Technologies Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA recall — FDA Z-1707-2020
Extended Expiration Date prior to clearance
Class IIFDA: TerminatedLife Technologies Corporation
Medical DeviceApr 22, 2020
Encore Medical djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF recall — FDA Z-1692-2020
The retaining ring on the neck trials has a potential to fail interoperatively.
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceApr 22, 2020
Life Technologies Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA recall — FDA Z-1706-2020
Extended Expiration Date prior to clearance
Class IIFDA: TerminatedLife Technologies Corporation
Medical DeviceApr 22, 2020
Life Technologies Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA recall — FDA Z-1704-2020
Extended Expiration Date prior to clearance
Class IIFDA: TerminatedLife Technologies Corporation
Medical DeviceApr 22, 2020
Smiths Medical ASD Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin recall — FDA Z-1715-2020
Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
Class IIFDA: TerminatedSmiths Medical ASD, Inc.
Medical DeviceApr 22, 2020
Canon Aquilion Premium, Model TSX-301B recall — FDA Z-1721-2020
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off…
Class IIFDA: OngoingCanon Medical System, USA, Inc.
Medical DeviceApr 22, 2020
Boston Scientific Neuromodulation Nitinol Thermocouple Electrode, 5cm - Product Usage: The recall — FDA Z-1698-2020
The firm initiated a voluntary correction of certain Cosman TCN Electrodes due to an incorrect revision of the Instructions for Use (IFU) being packaged with these products.
Class IIFDA: TerminatedBoston Scientific Neuromodulation Corporation
Medical DeviceApr 22, 2020
Merit Medical Systems ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v recall — FDA Z-1702-2020
A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.
Class IIFDA: TerminatedMerit Medical Systems, Inc.
Medical DeviceApr 22, 2020
Smiths Medical ASD Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for recall — FDA Z-1716-2020
Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
Class IIFDA: TerminatedSmiths Medical ASD, Inc.
Medical DeviceApr 22, 2020
Canon Aquilion One Vision, Model TSX-301C recall — FDA Z-1722-2020
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off…
Class IIFDA: OngoingCanon Medical System, USA, Inc.
Medical DeviceApr 22, 2020
Canon Aquilion Precision, Model TSX-304A recall — FDA Z-1725-2020
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off…
Class IIFDA: OngoingCanon Medical System, USA, Inc.
Medical DeviceApr 22, 2020
Canon Aquilion Lightning, Model TSX-036A recall — FDA Z-1719-2020
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off…
Class IIFDA: OngoingCanon Medical System, USA, Inc.
Medical DeviceApr 22, 2020
Canon Aquilion Prime, Model TSX-303A recall — FDA Z-1723-2020
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off…
Class IIFDA: OngoingCanon Medical System, USA, Inc.
Medical DeviceApr 22, 2020
Greiner Bio-One VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2% recall — FDA Z-1714-2020
Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.
Class IIFDA: TerminatedGreiner Bio-One North America, Inc.
Medical DeviceApr 22, 2020
Boddingtons Plastics Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF recall — FDA Z-1718-2020
Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)
Class IIFDA: TerminatedBoddingtons Plastics Ltd
Medical DeviceApr 22, 2020
Canon Aquilion Prime SP, Model TSX-303B recall — FDA Z-1724-2020
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off…
Class IIFDA: OngoingCanon Medical System, USA, Inc.
Medical DeviceApr 22, 2020
Sysmex The CF-70 instrument recall — FDA Z-1703-2020
Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an error condition occurs requiring the operator to open the cover door of the CF-70 to remove…
Class IIFDA: TerminatedSysmex America, Inc.
Medical DeviceApr 22, 2020
Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1 recall — FDA Z-1726-2020
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off…
Class IIFDA: OngoingCanon Medical System, USA, Inc.
Medical DeviceApr 22, 2020
Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the recall — FDA Z-1717-2020
When excessive amounts of urine spills on the rack transport track and reaches the electrical components of the CV-11 conveyor, there is a potential for smoke and/or sparks which may…
Class IIFDA: TerminatedSysmex America, Inc.
FoodApr 22, 2020
DSD Merchandisers Roasted/Salted Deluxe Mixed Nuts recall — FDA F-0909-2020
Firm discovered that peanuts were included in mixed nut mix but not declared in labeling.
Class IIFDA: TerminatedDSD Merchandisers, Inc.
FoodApr 22, 2020
Mountain Rose Inc. dba Mountain Rose Herbs Kudzu Root recall — FDA F-0892-2020
Salmonella
Class IFDA: TerminatedMountain Rose Inc. dba Mountain Rose Herbs
FoodApr 22, 2020
CT Health Solutions We Like Vitamins, Lycopene 50 mg, Dietary Supplement, 200 recall — FDA F-0923-2020
Due to different color of powder in capsules. Firm's evaluation determined product low potency.
Class IIIFDA: TerminatedCT Health Solutions, LLC
DrugApr 22, 2020
Filltech USA Dermatone recall — FDA D-1241-2020
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
Class IIFDA: TerminatedFilltech USA, 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.