FoodSep 9, 2020
Giant Eagle 12" DELUXE PIZZA recall — FDA F-1399-2020
Potential contamination with Salmonella Newport in onions and prepared foods containing onions.
Class IIFDA: TerminatedGiant Eagle
September 2020 recalls — page 12
These records include useful source details for the selected month.
FoodSep 9, 2020
Sundial Herbal Products Jamaican Bissy Powder recall — FDA F-1446-2020
Recall required by Order of Permanent Injunction. The products are misbranded and deemed unapproved drugs based on labeling claims.
Class IIFDA: TerminatedSundial Herbal Products
FoodSep 9, 2020
Giant Eagle MD S&F: SMOKE-STACKED SANDWICH PLU#29662600000 recall — FDA F-1417-2020
Potential contamination with Salmonella Newport in onions and prepared foods containing onions.
Class IFDA: TerminatedGiant Eagle
FoodSep 9, 2020
Giant Eagle GE Egg & Bacon Salad With French Dressing PLU# 23665100000 recall — FDA F-1386-2020
Potential contamination with Salmonella Newport in onions and prepared foods containing onions.
Class IFDA: TerminatedGiant Eagle
FoodSep 9, 2020
Giant Eagle MD G&G Greek Salad PLU#23662500000 recall — FDA F-1385-2020
Potential contamination with Salmonella Newport in onions and prepared foods containing onions.
Class IFDA: TerminatedGiant Eagle
FoodSep 9, 2020
Giant Eagle MD Philly Style Steak Stromboli Cold PLU#23676600000 recall — FDA F-1387-2020
Potential contamination with Salmonella Newport in onions and prepared foods containing onions.
Class IIFDA: TerminatedGiant Eagle
FoodSep 9, 2020
Giant Eagle Cajun Style Chicken Meal PLU# 24658700000 recall — FDA F-1388-2020
Potential contamination with Salmonella Newport in onions and prepared foods containing onions.
Class IIFDA: TerminatedGiant Eagle
FoodSep 9, 2020
Giant Eagle MD Salad Bar- Cucumber Tomato Salad recall — FDA F-1367-2020
Potential contamination with Salmonella Newport in onions and prepared foods containing onions.
Class IFDA: TerminatedGiant Eagle
DrugSep 9, 2020
AAA Cosmetica, SA de CV bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 recall — FDA D-1569-2020
CGMP Deviations
Class IIFDA: TerminatedAAA Cosmetica, SA de CV
DrugSep 9, 2020
ROQUE PLAST, S.A. DE C.V Command Brands GelAnti Bac Instant Hand Sanitizer, 70% Alcohol, , 8 recall — FDA D-1559-2020
CGMP Deviation: Potential contamination with undeclared methanol.
Class IIFDA: TerminatedROQUE PLAST, S.A. DE C.V.
DrugSep 9, 2020
Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial recall — FDA D-1575-2020
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection,…
Class IFDA: TerminatedMylan Institutional LLC
DrugSep 9, 2020
Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial recall — FDA D-1576-2020
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection,…
Class IFDA: TerminatedMylan Institutional LLC
DrugSep 9, 2020
AAA Cosmetica, SA de CV bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 recall — FDA D-1570-2020
Chemical Contamination: Product contains methanol.
Class IFDA: TerminatedAAA Cosmetica, SA de CV
DrugSep 9, 2020
Laboratorios Jaloma S.A. de C.V Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with recall — FDA D-1555-2020
cGMP deviations
Class IIFDA: TerminatedLaboratorios Jaloma S.A. de C.V.
DrugSep 9, 2020
SG24 Skin Guard 24 All-Day Hand Sanitizer 1 4"x6" Hand Sanitizing Towelette recall — FDA D-1574-2020
Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug
Class IFDA: TerminatedSG24 LLC
VehicleSep 4, 2020
Hyundai Motor control unit/module recall — NHTSA campaign 20V543000
Hyundai Motor America (Hyundai) recalled certain 2019-2021 Tucson vehicles on September 4, 2020. On December 30, 2020, Hyundai expanded the recall population, and added certain 2016-2018…
control unit/moduleHyundai Motor America
VehicleSep 3, 2020
General Motors critical fasteners recall — NHTSA campaign 20V537000
General Motors LLC (GM) is recalling certain 2020 Buick Encore GX and 2021 Chevrolet Trailblazer vehicles. The rear attachment bolts of one or both front seats may not have been installed.
critical fastenersGeneral Motors LLC
Medical DeviceSep 2, 2020
Neurovision Medical Products Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only recall — FDA Z-2908-2020
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending,…
Class IIFDA: TerminatedNeurovision Medical Products Inc.
Medical DeviceSep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N recall — FDA Z-2834-2020
Potential Endotoxin Contamination
Class IIFDA: OngoingDatascope Corporation
Medical DeviceSep 2, 2020
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N recall — FDA Z-2840-2020
Potential Endotoxin Contamination
Class IIFDA: OngoingDatascope Corporation
Medical DeviceSep 2, 2020
GE Healthcare CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor recall — FDA Z-2883-2020
The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered.
Class IIFDA: TerminatedGE Healthcare, LLC
Medical DeviceSep 2, 2020
Karl Storz Endoscopy Flexible Intubation Video Endoscope, Part: 11301BNX, with Instruction recall — FDA Z-2891-2020
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible…
Class IIFDA: OngoingKarl Storz Endoscopy
Medical DeviceSep 2, 2020
Neurovision Medical Products Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube recall — FDA Z-2901-2020
The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may soften over time so that it may be more susceptible to damage by scratching or bending,…
Class IIFDA: TerminatedNeurovision Medical Products Inc.
Medical DeviceSep 2, 2020
Karl Storz Endoscopy Flexible DCI Intubation Fiberscope, Part: 11301BND1, with Instruction recall — FDA Z-2894-2020
Updated sterilization instructions are being provided to ensure 1) a specific sterilization tray is not used, and 2) ethylene oxide sterilization is never used on certain reusable flexible…
Class IIFDA: OngoingKarl Storz Endoscopy
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.