Medical DeviceApr 8, 2020
Gentell Hydrogel Ag 4oz recall — FDA Z-1626-2020
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Class IIFDA: OngoingGentell, Inc.
Monthly breakdown
2020 recalls by month
Select a month to review the recall records reported during that period.
December 2020315 records · 4 categoriesNovember 2020241 records · 4 categoriesOctober 2020416 records · 4 categoriesSeptember 2020371 records · 4 categoriesAugust 2020245 records · 4 categoriesJuly 2020442 records · 4 categoriesJune 2020342 records · 4 categoriesMay 2020315 records · 4 categoriesApril 2020422 records · 4 categoriesMarch 2020368 records · 4 categoriesFebruary 2020551 records · 4 categoriesJanuary 2020224 records · 4 categories
2020 recalls — page 125
Records are ordered by the best available source date.
Medical DeviceApr 8, 2020
Philips Expression MR400 MRI Patient Monitoring System recall — FDA Z-1616-2020
Menu selections for users to access the oxygen (O2) sensor calibration were changed and not incorporated into the device s Instructions for Use. As a result, the instructions for performing…
Class IIFDA: TerminatedPhilips North America, LLC
Medical DeviceApr 8, 2020
Trilliant Surgical Instructions for Use and Surgical Cleaning and Sterilization Protocol for recall — FDA Z-1609-2020
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
Class IIFDA: TerminatedTrilliant Surgical, LLC
Medical DeviceApr 8, 2020
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a recall — FDA Z-1600-2020
Distributed without an approved 510(k)
Class IIFDA: TerminatedButterfly Network, Inc.
Medical DeviceApr 8, 2020
Trilliant Surgical Instructions for Use and Surgical Cleaning and Sterilization Protocol recall — FDA Z-1605-2020
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
Class IIFDA: TerminatedTrilliant Surgical, LLC
Medical DeviceApr 8, 2020
Maquet Cardiovascular Us Sales Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI recall — FDA Z-1603-2020
A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle portion of the kit; 81 of 255 kits were assembled with an incorrect Arterial…
Class IIFDA: TerminatedMaquet Cardiovascular Us Sales, LLC
Medical DeviceApr 8, 2020
Respironics California Philips V60 Ventilators with Power Management PCBA part number recall — FDA Z-1622-2020
Solder connection failure on Power Management printed circuit board assembly of ventilators may cause 1) Blower to lose power, spool down, and trigger visual and audible High Priority Check…
Class IIFDA: OngoingRespironics California, LLC
Medical DeviceApr 8, 2020
Gentell Hydrogel Ag 4x4, model no recall — FDA Z-1624-2020
During an FDA audit, it was discovered that the product was not properly registered with FDA.
Class IIFDA: OngoingGentell, Inc.
Medical DeviceApr 8, 2020
Trilliant Surgical 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel recall — FDA Z-1635-2020
The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect contents of the 8mm HTR Sterile Hammer Toe Reaming Kit. The kit should contain…
Class IIFDA: TerminatedTrilliant Surgical, LLC
Medical DeviceApr 8, 2020
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88 recall — FDA Z-1567-2020
There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
Class IFDA: OngoingLeMaitre Vascular, Inc.
FoodApr 8, 2020
National Vitamin Company Nature's Blend Folic Acid 1000 mcg Dietary Supplement recall — FDA F-0872-2020
Customer reports of label error. Front panel states strength of 1000 mg although supplement fact is correct in stating 1000 mcg.
Class IIIFDA: TerminatedNational Vitamin Company Inc.
FoodApr 8, 2020
Mcclancy Seasoning Company Case Label: Rice Dirty Mix Comp 24-17.9 oz bags/case, PACKED recall — FDA F-0870-2020
The firm was notified by their rice supplier that the product contains blue plastic slivers.
Class IIFDA: CompletedMcclancy Seasoning Company
FoodApr 8, 2020
Driscoll's Blackberries recall — FDA F-0865-2020
Testing found Acephate of 2.8ppm on fresh blackberries. There is no US MRL for Acephate on blackberries.
Class IIFDA: TerminatedDriscoll's Inc.
FoodApr 8, 2020
Raw Seafoods Food You Feel Good About, Ginger Salmon, Oven Safe recall — FDA F-0873-2020
The firm initiated a recall on 03/13/20 of frozen oven-safe Cook-in-bag Salmon for undeclared wheat
Class IIFDA: TerminatedRaw Seafoods Inc.
FoodApr 8, 2020
Raw Seafoods Food You Feel Good About Brand, Salmon Teriyaki, Oven Safe recall — FDA F-0874-2020
The firm initiated a recall on 03/13/20 of frozen oven-safe Cook-in-bag Salmon for undeclared wheat
Class IIFDA: TerminatedRaw Seafoods Inc.
FoodApr 8, 2020
New Capstone ReStructure VANILLA PROTEIN POWDER NET WT recall — FDA F-0871-2020
The firm was notified that the labeling does not include the word milk on the ingredient statement
Class IFDA: TerminatedNew Capstone, Inc.
FoodApr 8, 2020
Vitamin Cottage Natural Food Markets NATURAL GROCERS PEANUT CLUSTERS DK CHOCOLATE NON-GMO, 8 recall — FDA F-0876-2020
Undeclared almond and milk allergens
Class IIFDA: TerminatedVitamin Cottage Natural Food Markets, Inc.
FoodApr 8, 2020
Advanced Fresh Concepts Sushi Ebi Cooked Butterfly Tail-On Whiteleg Shrimp recall — FDA F-0875-2020
Firm testing found Vibrio parahaemolyticus in cooked butterfly shrimp from Thailand.
Class IIFDA: TerminatedAdvanced Fresh Concepts Corp
FoodApr 8, 2020
Forest Mushroom Food Guan's Enoki Mushrooms recall — FDA F-0910-2020
California Department of Public Health collected samples at retail and found Listeria monocytogenes in Enoki mushrooms from Korea
Class IFDA: TerminatedForest Mushroom Food Inc.
FoodApr 8, 2020
Vitamin Cottage Natural Food Markets NATURAL GROCERS ALMOND CLUSTERS DK CHOCOLATE NON-GMO, 8 recall — FDA F-0877-2020
Undeclared peanut and milk allergens
Class IIFDA: TerminatedVitamin Cottage Natural Food Markets, Inc.
DrugApr 8, 2020
Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) recall — FDA D-1094-2020
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Class IFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugApr 8, 2020
Akorn Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton recall — FDA D-1258-2020
Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.
Class IIIFDA: TerminatedAkorn Inc.
DrugApr 8, 2020
Y-O Management LLC, dba Natural Remedy Store Natural Remedies Active Male 500 mg Male recall — FDA D-1080-2020
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction
Class IFDA: TerminatedY-O Management LLC, dba Natural Remedy Store
DrugApr 8, 2020
Medical Center Pharmacy *Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle recall — FDA D-1077-2020
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class IIFDA: TerminatedMedical Center Pharmacy, Inc.
About the 2020 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.