Medical DeviceMay 22, 2019
Abbott Alinity ci-series System Control Module software version 2.5.1 recall — FDA Z-1316-2019
Potential performance issues in the Alinity-ci software version 2.5.1
Class IIFDA: TerminatedAbbott Gmbh & Co. KG
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 148
Records are ordered by the best available source date.
Medical DeviceMay 22, 2019
Abbott Laboratories Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus recall — FDA Z-1363-2019
Devices were delivered without the required dry ice.
Class IIIFDA: TerminatedAbbott Laboratories
Medical DeviceMay 22, 2019
Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a recall — FDA Z-1353-2019
Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
Class IIFDA: TerminatedAbbott Ireland Diagnostics Division
Medical DeviceMay 22, 2019
Siemens Medical Solutions USA Artis Zeego (material 10280959) - Product Usage: AXIOM Artis recall — FDA Z-1340-2019
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMay 22, 2019
Shippert Medical Technologies Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile recall — FDA Z-1334-2019
Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Class IIFDA: CompletedShippert Medical Technologies
Medical DeviceMay 22, 2019
Becton Dickinson & Co BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor recall — FDA Z-1314-2019
Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and…
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceMay 22, 2019
Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX recall — FDA Z-1325-2019
Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
Class IIFDA: TerminatedPENTAX of America Inc.
Medical DeviceMay 22, 2019
Opgen CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA recall — FDA Z-1328-2019
May show diminished performance prior to its established expiration date resulting in an invalid control result for the KTOll GNR PNA FISH Test
Class IIFDA: TerminatedOpgen Inc.
Medical DeviceMay 22, 2019
Moller Vital Molift 2-Point sling bar, an accessory for Molift Mover 180/Air recall — FDA Z-1352-2019
The firm has received 7 reports of malfunction for the device in which the hooks have broken off, potentially leading the sling to slip out of the sling bar and causing the patient to fall.
Class IIFDA: OngoingMoller Vital
Medical DeviceMay 22, 2019
Abbott Laboratories ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO recall — FDA Z-1361-2019
Devices were delivered without the required dry ice.
Class IIIFDA: TerminatedAbbott Laboratories
Medical DeviceMay 22, 2019
Philips SureSigns VS3 NBP Temp, Product Number 863070 recall — FDA Z-1318-2019
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Class IIFDA: OngoingPhilips North America, LLC
Medical DeviceMay 22, 2019
Ethicon Endo-Surgery Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A recall — FDA Z-1271-2019
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Class IFDA: CompletedEthicon Endo-Surgery Inc.
Medical DeviceMay 22, 2019
Abbott Laboratories ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage recall — FDA Z-1360-2019
Devices were delivered without the required dry ice.
Class IIIFDA: TerminatedAbbott Laboratories
Medical DeviceMay 22, 2019
Ethicon Endo-Surgery Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The recall — FDA Z-1278-2019
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Class IFDA: CompletedEthicon Endo-Surgery Inc.
Medical DeviceMay 22, 2019
Shippert Medical Technologies Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile recall — FDA Z-1336-2019
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
Class IIFDA: CompletedShippert Medical Technologies
Medical DeviceMay 22, 2019
Abbott Laboratories ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact recall — FDA Z-1358-2019
Devices were delivered without the required dry ice.
Class IIIFDA: TerminatedAbbott Laboratories
Medical DeviceMay 22, 2019
Ethicon Endo-Surgery Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The recall — FDA Z-1276-2019
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Class IFDA: CompletedEthicon Endo-Surgery Inc.
Medical DeviceMay 22, 2019
Compass Health Brands MediPress pneumatic compression system, Half Leg-Segmental Gradient recall — FDA Z-1343-2019
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Class IIFDA: TerminatedCompass Health Brands (Corporate Office)
FoodMay 22, 2019
Twin City Foods Signature Kitchens Green Peas & Diced Carrots recall — FDA F-1446-2019
Product recalled due to potential for contamination with Listeria monocytogenes.
Class IIFDA: TerminatedTwin City Foods Inc.
FoodMay 22, 2019
Barlean's Item FG 10116, Barlean s, Master Blend Total Omega 3.6.9 recall — FDA F-1365-2019
Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.
Class IIIFDA: TerminatedBarlean's LLC
FoodMay 22, 2019
AmeriHerb International Goldenseal herb c/s, Hydrastis Canadensis, Not for use during recall — FDA F-1388-2019
Dried spice and herb products potentially contaminated with generic E. coli.
Class IIFDA: TerminatedAmeriHerb International Inc.
FoodMay 22, 2019
Barlean's Item FG 10191, Barlean s Ideal CBD Hemp Oil Softgel, 900 mg recall — FDA F-1369-2019
Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.
Class IIIFDA: TerminatedBarlean's LLC
FoodMay 22, 2019
NATURE DELIVERED Graze, Dark Chocolate Cherry Tart net weight / number of units recall — FDA F-1347-2019
The product contains almonds which are not declared on the label. Instead, pecans are declared on the label but is not an ingredient in the product.
Class IIFDA: TerminatedNATURE DELIVERED Inc.
FoodMay 22, 2019
Barlean's Item FG 10089, Barlean s, Fish Oil Omega-3 EPA/DHA Orange recall — FDA F-1363-2019
Barlean's dietary supplement product is recalled due to undeclared Sulfites. Sulfite levels of finished goods does not exceed 10 ppm.
Class IIIFDA: TerminatedBarlean's LLC
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.