FoodDec 9, 2020
Tanimura & Antle brand Romaine lettuce recall — FDA F-0145-2021
Michigan Department of Agriculture and Rural Development found E.coli O157:H7 in romaine lettuce during routine sampling.
Class IFDA: TerminatedTanimura & Antle
Latest records
Latest recalls — page 933
The newest recall records with useful source details are listed here.
FoodDec 9, 2020
Sunnyside Farms Dole Brands, Savory Spinach Dijon, 4.9 oz recall — FDA F-0142-2021
Sunnyside Farms 215 N. Mill Road Vineland, NJ 08360 has initiated a recall of Dole Brands, Savory Spinach Dijon, 4.9oz , 6 per case & 8 per case 150 of each because product is mislabeled…
Class IIFDA: TerminatedSunnyside Farms
FoodDec 9, 2020
J F C International YAGUMO AMANATTO GIFT BOX 6P 6/19.01 OZ JAN Code: 49 03089 recall — FDA F-0178-2021
Ama Natto (Sugar coated sweet beans) imported from Japan contains mold or the product may develop mold prior the best before date.
Class IIFDA: TerminatedJ F C International Inc.
DrugDec 9, 2020
REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g) recall — FDA D-0118-2021
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Class IFDA: TerminatedMPM Medical LLC
DrugDec 9, 2020
InvaTech Pharma Solutions Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle recall — FDA D-0115-2021
Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
Class IIIFDA: TerminatedInvaTech Pharma Solutions, LLC
DrugDec 9, 2020
Lohxa Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free recall — FDA D-0111-2021
Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.
Class IFDA: TerminatedLohxa LLC
DrugDec 9, 2020
The Harvard Drug Group Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton recall — FDA D-0114-2021
Failed Dissolution Specifications: Out of specification for dissolution.
Class IIFDA: TerminatedThe Harvard Drug Group
DrugDec 9, 2020
US Pharmaceuticals CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g) recall — FDA D-0113-2021
Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.
Class IIFDA: TerminatedUS Pharmaceuticals Inc.
DrugDec 9, 2020
Golden State Medical Supply ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles recall — FDA D-0112-2021
FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets
Class IIFDA: TerminatedGolden State Medical Supply Inc.
VehicleDec 9, 2020
BMW 12v/24v/48v battery recall — NHTSA campaign 20V761000
BMW of North America, LLC (BMW) is recalling certain 2021 M340i xDrive, M440i xDrive Coupe, 530i, 530i xDrive, 540i, 540i xDrive, 740Li, 740Li xDrive, 840i Gran Coupe, 840i xDrive Gran…
12v/24v/48v batteryBMW of North America, LLC
Medical DeviceDec 2, 2020
Encore Medical EMPOWR Partial Knee Peg Drill recall — FDA Z-0480-2021
There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the…
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceDec 2, 2020
Flexicare Medical ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0 recall — FDA Z-0497-2021
When the video stylet cuff is over-inflated there is potential for occlusion of the corrugated section of the ETT, and increased resistance to gas flow and difficulty in ventilating the…
Class IFDA: TerminatedFlexicare Medical Ltd.
Medical DeviceDec 2, 2020
Encore Medical EMPOWR Partial Knee Peg Drill Guide recall — FDA Z-0479-2021
There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the…
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceDec 2, 2020
Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of recall — FDA Z-0490-2021
Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for…
Class IIFDA: TerminatedGeistlich Pharma North America, Inc.
Medical DeviceDec 2, 2020
Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of recall — FDA Z-0491-2021
Difficult to expel Geistlich Bio-Oss granules from the pen, resistance could suddenly drop, and the granules may be expelled all at once, causing surrounding tissue, particularly in use for…
Class IIFDA: TerminatedGeistlich Pharma North America, Inc.
Medical DeviceDec 2, 2020
MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number recall — FDA Z-0483-2021
Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.
Class IIFDA: TerminatedBayer Medical Care, Inc.
Medical DeviceDec 2, 2020
MEDTRONIC ATS MEDICAL Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3 recall — FDA Z-0494-2021
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Class IIFDA: TerminatedMEDTRONIC ATS MEDICAL, Inc.
Medical DeviceDec 2, 2020
Hill-Rom Manufacturing Life2000 Ventilation System, including Life2000 Ventilator and recall — FDA Z-0484-2021
Under certain conditions, there is a risk for fire.
Class IIFDA: TerminatedHill-Rom Manufacturing, Inc.
Medical DeviceDec 2, 2020
Advanced Bionics AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 recall — FDA Z-0486-2021
Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.
Class IIIFDA: TerminatedAdvanced Bionics, LLC
Medical DeviceDec 2, 2020
Luminex Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R recall — FDA Z-0477-2021
Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases,…
Class IIFDA: TerminatedLuminex Corporation
Medical DeviceDec 2, 2020
MEVION S250i, MEVION S250 recall — FDA Z-0485-2021
Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur
Class IIFDA: TerminatedMevion Medical Systems, Inc.
Medical DeviceDec 2, 2020
Coloplast Manufacturing US Titan Pump - Product Usage: indicated for male patients suffering recall — FDA Z-0488-2021
Potential increased occurrence of pump fracture over the lifetime of the device.
Class IIFDA: TerminatedColoplast Manufacturing US, LLC
Medical DeviceDec 2, 2020
Luminex Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R recall — FDA Z-0476-2021
Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases,…
Class IIFDA: TerminatedLuminex Corporation
Medical DeviceDec 2, 2020
MEDTRONIC ATS MEDICAL Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2 recall — FDA Z-0493-2021
There is a potential defect in the seals of the sterile barrier pouch used to package the CryoFlex disposables devices
Class IIFDA: TerminatedMEDTRONIC ATS MEDICAL, Inc.
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