DrugAug 19, 2020
Lidocaine Patch 5% recall — FDA D-1492-2020
Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
Class IIFDA: TerminatedTeva Pharmaceuticals USA
August 2020 recalls — page 6
These records include useful source details for the selected month.
DrugAug 19, 2020
Eosera Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) recall — FDA D-1501-2020
cGMP Deviations.
Class IIFDA: TerminatedEosera, Inc.
DrugAug 19, 2020
Taro Pharmaceuticals U.S.A Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC recall — FDA D-1496-2020
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Class IIIFDA: TerminatedTaro Pharmaceuticals U.S.A., Inc.
DrugAug 19, 2020
Itech 361 All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00% recall — FDA D-1538-2020
Chemical Contamination: Product contains undeclared methanol.
Class IFDA: TerminatedItech 361 LLC
VehicleAug 18, 2020
BMW 12v/24v/48v battery recall — NHTSA campaign 20V490000
BMW of North America, LLC (BMW) is recalling certain 2021 330e and X5 xDrive45e, 2020-2021 X3 xDrive30e, and 2020 MINI Countryman SE ALL4 vehicles. Loose welding beads may form a conductive…
12v/24v/48v batteryBMW of North America, LLC
VehicleAug 14, 2020
BMW tires recall — NHTSA campaign 20V483000
BMW of North America, LLC (BMW) is recalling certain 2021 X6 (sDrive40i, xDrive40i and M50i) and X5 (sDrive40i, xDrive40i and M50i) vehicles equipped with certain Pirelli tires. The tires…
tiresBMW of North America, LLC
Medical DeviceAug 12, 2020
Smiths Medical ASD Medfusion Syringe Pump Model 3500, Software Version V6.0 recall — FDA Z-2735-2020
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Class IFDA: OngoingSmiths Medical ASD Inc.
Medical DeviceAug 12, 2020
Boston Scientific Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a recall — FDA Z-2760-2020
BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure…
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceAug 12, 2020
Becton Dickinson & Co BD MAX SARS-CoV-2 Reagents, Cat recall — FDA Z-2754-2020
BD is experiencing elevated rates of potential false positive results from certain customers when using the BD SARS-CoV-2 Reagents for the BD MAX System. False positive test results could…
Class IIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceAug 12, 2020
TELEFLEX MEDICAL Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product recall — FDA Z-2748-2020
Potential for sterile packaging to be compromised
Class IIFDA: TerminatedTELEFLEX MEDICAL Inc.
Medical DeviceAug 12, 2020
Randox Lipase Assay: Lipase Colorimetric Reagent - Product Usage: A Lipase test system is a recall — FDA Z-2751-2020
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.
Class IIFDA: TerminatedRANDOX LABORATORIES, LTD.
Medical DeviceAug 12, 2020
Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is recall — FDA Z-2752-2020
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches.
Class IIFDA: TerminatedRANDOX LABORATORIES, LTD.
Medical DeviceAug 12, 2020
Smiths Medical ASD Medfusion Syringe Pump Model 4000 recall — FDA Z-2734-2020
Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Class IFDA: OngoingSmiths Medical ASD Inc.
Medical DeviceAug 12, 2020
SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to recall — FDA Z-2755-2020
Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the…
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceAug 12, 2020
CareFusion 303 Alaris Syringe Module Model 8110, a modular infusion pump and monitoring recall — FDA Z-2719-2020
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that…
Class IFDA: TerminatedCareFusion 303, Inc.
Medical DeviceAug 12, 2020
Covidien Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use recall — FDA Z-2768-2020
This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the…
Class IIFDA: OngoingCovidien LLC
Medical DeviceAug 12, 2020
Boston Scientific Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a recall — FDA Z-2759-2020
BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure…
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceAug 12, 2020
Sutter Swyng non-stick bipolar forceps - Product Usage: single-use re electrosurgical recall — FDA Z-2744-2020
The label on the cardbox and the blister show the correct symbols for sterilization using irradiation and storage at 5 C to 40 C, the package insert (IFU) is labelled incorrectly. It shows…
Class IIFDA: TerminatedSutter Medizintechnik GmbH
Medical DeviceAug 12, 2020
CareFusion 303 Alaris System PC Unit Model 8000 modular infusion pump and monitoring system recall — FDA Z-2740-2020
If one or more screws or washers are loose or missing causing the battery not to be properly secured to the PC Unit, that is running on battery power, the system may experience a power loss…
Class IFDA: TerminatedCareFusion 303, Inc.
Medical DeviceAug 12, 2020
Medline Industries Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes recall — FDA Z-2766-2020
Potential risk of brush detachment during cleaning.
Class IIFDA: TerminatedMedline Industries Inc.
Medical DeviceAug 12, 2020
Randox Lipase Assay: Lipase Colorimetric R2 Substrate - Product Usage: A Lipase test system recall — FDA Z-2753-2020
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.
Class IIFDA: TerminatedRANDOX LABORATORIES, LTD.
Medical DeviceAug 12, 2020
CareFusion 303 Alaris PCA Module Model 8120, a modular infusion pump and monitoring system recall — FDA Z-2720-2020
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that…
Class IFDA: TerminatedCareFusion 303, Inc.
Medical DeviceAug 12, 2020
CareFusion 303 Alaris System PC Unit Model 8000, a modular infusion pump and monitoring recall — FDA Z-2716-2020
Cleaning agents may damage Inter-Unit Interface (IUI) Connectors, which may lead to interruption of communication or power between PC Unit and modules, which may result in an infusion that…
Class IFDA: TerminatedCareFusion 303, Inc.
Medical DeviceAug 12, 2020
Boston Scientific Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire recall — FDA Z-2764-2020
BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure…
Class IIFDA: OngoingBoston Scientific Corporation
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.