Medical DeviceDec 25, 2019
Angiodynamics OARtrac PLUS CLINICAL DETECTOR UNIT recall — FDA Z-0710-2020
May result in readings outside of the expected accuracy range.
Class IIFDA: TerminatedAngiodynamics, Inc.
December 2019 recalls — page 2
These records include useful source details for the selected month.
Medical DeviceDec 25, 2019
DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP recall — FDA Z-0706-2020
The Warrior Recovery Knee Brace has the potential to come apart due to the hinge breaking.
Class IIFDA: OngoingDeRoyal Industries Inc.
Medical DeviceDec 25, 2019
GE Healthcare Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. recall — FDA Z-0117-2020
Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceDec 25, 2019
Siemens Medical Solutions USA Artis zee/ zeego Interventional Fluoroscopic X-Ray System recall — FDA Z-0695-2020
In affected Artis zee floor Interventional Fluoroscopic X-Ray Systems, the activation of a collision sensor will cause a block the movement of the floating tabletop and could result in a…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceDec 25, 2019
Polymer Technology Systems CVS Health At Home A1C Test Kit, Software Version Revision D, REF recall — FDA Z-0686-2020
A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
Class IIFDA: TerminatedPolymer Technology Systems
Medical DeviceDec 25, 2019
TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile recall — FDA Z-0694-2020
A limited number of lenses may be mislabeled with the incorrect diopter power.
Class IIFDA: TerminatedTekia, Inc.
Medical DeviceDec 25, 2019
Allergan PLC Natrelle Saline-Filled Breast Implant, for the following Styles and sizes recall — FDA Z-0699-2020
The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length…
Class IIIFDA: TerminatedAllergan PLC
Medical DeviceDec 25, 2019
NxStage Medical Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) recall — FDA Z-0697-2020
There is a potential patient health risk while performing chronic hemodialysis treatments in the home setting with for patients with low blood volume (2.4 Liters or less in a patient with…
Class IIFDA: TerminatedNxStage Medical, Inc.
Medical DeviceDec 25, 2019
Polymer Technology Systems A1CNow SELF CHECK (European), Software Version Revision D, REF recall — FDA Z-0683-2020
A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
Class IIFDA: TerminatedPolymer Technology Systems
Medical DeviceDec 25, 2019
Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130 recall — FDA Z-0715-2020
Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceDec 25, 2019
GE Healthcare Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. recall — FDA Z-0116-2020
Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceDec 25, 2019
Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J recall — FDA Z-0716-2020
Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly…
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceDec 25, 2019
Allergan PLC Natrelle Silicone Filled Breast Implants for the following Styles and Sizes recall — FDA Z-0700-2020
The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length…
Class IIIFDA: TerminatedAllergan PLC
Medical DeviceDec 25, 2019
Angiodynamics OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT recall — FDA Z-0709-2020
May result in readings outside of the expected accuracy range.
Class IIFDA: TerminatedAngiodynamics, Inc.
Medical DeviceDec 25, 2019
GE Healthcare Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) recall — FDA Z-0115-2020
Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may…
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceDec 25, 2019
Bio-Signal Group HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03 recall — FDA Z-0704-2020
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
Class IIFDA: TerminatedBio-Signal Group Corp.
FoodDec 25, 2019
Huy Fong Foods Siracha HOT Chili Sauce Net Wt recall — FDA F-0342-2020
Firm received complaint of Siracha sauce bulging at top seal and exploding upon removing seal
Class IIIFDA: TerminatedHuy Fong Foods, Inc.
FoodDec 25, 2019
Cell-nique Corp dba Living Harvest at Hudson Hodgson Mill Unbleached All-Purpose White Wheat recall — FDA F-0346-2020
Flour may be contaminated with STEC E, coli
Class IIFDA: TerminatedCell-nique Corp dba Living Harvest at Hudson River…
FoodDec 25, 2019
Stern Produce Company Queen Victoria Sweet Baby Broccoli from Ippolito recall — FDA F-0347-2020
Firm is recalling one lot of baby broccoli because it may be contaminated with bacteria contained in dripping ice water from a drain tray in the cooler.
Class IIFDA: TerminatedStern Produce Company Inc.
FoodDec 25, 2019
Slade Gorton & Company GOURMET BAY Flounder with Crabmeat Stuffing recall — FDA F-0341-2020
Product stuffing may be contaminated with Listeria monocytogenes
Class IIFDA: TerminatedSlade Gorton & Company, Inc.
FoodDec 25, 2019
Slade Gorton & Company GOURMET BAY Salmon Roast with Crabmeat Stuffing recall — FDA F-0340-2020
Product stuffing may be contaminated with Listeria monocytogenes
Class IIFDA: TerminatedSlade Gorton & Company, Inc.
FoodDec 25, 2019
Dole Fresh Vegetables Tri-Color Coleslaw - Marketside brand recall — FDA F-0350-2020
Canadian Food Inspection Agency reported finding Salmonella in a sample of Coleslaw with Green and Red Cabbage and Carrots.
Class IFDA: TerminatedDole Fresh Vegetables Inc.
FoodDec 25, 2019
Whole Foods Market Catering, Kale and Brussels Sprouts Salad Small UPC 106487 and recall — FDA F-0369-2020
Possible contamination with Listeria monocytogenes
Class IFDA: TerminatedWhole Foods Market
FoodDec 25, 2019
Tropical Nut & Fruit Company Truly Good Foods SOUTH OF THE BORDER nut mix NET CT/WT: 25lb recall — FDA F-0338-2020
The firm discovered that the product inside the South of the Border box is a different product with different allergens from what the label stated. Product was distributed in cardboard…
Class IIFDA: TerminatedTropical Nut & Fruit Company
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.