DrugAug 25, 2021
COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) Combipatch recall — FDA D-0724-2021
Failed Stability Specifications; out of specification for shear.
Class IIFDA: OngoingNoven Pharmaceuticals Inc.
August 2021 recalls — page 4
These records include useful source details for the selected month.
DrugAug 25, 2021
Teva Pharmaceuticals USA Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single recall — FDA D-0739-2021
Lack of Assurance of Sterility
Class IIFDA: TerminatedTeva Pharmaceuticals USA
DrugAug 25, 2021
Teva Pharmaceuticals USA Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL recall — FDA D-0731-2021
Lack of Assurance of Sterility
Class IIFDA: TerminatedTeva Pharmaceuticals USA
VehicleAug 23, 2021
Ford curtain recall — NHTSA campaign 21V652000
Ford Motor Company (Ford) is recalling certain 2021 Explorer and Lincoln Aviator vehicles. The side air bag attachment weld studs could detach during the deployment of the side air bag,…
curtainFord Motor Company
VehicleAug 23, 2021
F-150 Super Cab webbing recall — NHTSA campaign 21V653000
Ford Motor Company (Ford) is recalling certain 2021 F-150 Super Cab vehicles. The front seatbelt webbing may be incorrectly routed.
webbingFord Motor Company
VehicleAug 20, 2021
Taos hoses, lines/piping, and fittings recall — NHTSA campaign 21V651000
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2022 Taos vehicles. The underhood fuel supply quick-connector may detach from the fuel supply line causing a fuel leak in…
hoses, lines/piping, and fittingsVolkswagen Group of America, Inc.
VehicleAug 20, 2021
General Motors critical fasteners recall — NHTSA campaign 21V649000
General Motors, LLC (GM) is recalling certain 2016-2021 Chevrolet Malibu and 2019-2021 Cadillac XT4 vehicles. The rear seat belt retractors may be improperly secured with loose or missing…
critical fastenersGeneral Motors, LLC
Medical DeviceAug 18, 2021
Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens recall — FDA Z-2280-2021
There is a potential for internal leaks within catheters.
Class IIFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceAug 18, 2021
Stryker Medical Division of Stryker Prime TC-transport chair intended for medical purposes recall — FDA Z-2209-2021
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
Class IIFDA: OngoingStryker Medical Division of Stryker Corporation
Medical DeviceAug 18, 2021
QURA S.R.L Spectrum Medical Quantum Standard heat exchanger recall — FDA Z-2277-2021
Product labeled as sterile may not have been adequately sterilized. In addition, these devices were imported to the US distributor, but the devices are not 510(k) cleared in the US.
Class IIFDA: TerminatedQURA S.R.L.
Medical DeviceAug 18, 2021
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to recall — FDA Z-2240-2021
Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage,…
Class IIFDA: TerminatedCovidien LLC
Medical DeviceAug 18, 2021
Stryker Medical Division of Stryker Isolibrium Support Surface - support surface assists in recall — FDA Z-2215-2021
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
Class IIFDA: OngoingStryker Medical Division of Stryker Corporation
Medical DeviceAug 18, 2021
Stryker Medical Division of Stryker TruRize Clinical Chair - support structure that places recall — FDA Z-2217-2021
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
Class IIFDA: OngoingStryker Medical Division of Stryker Corporation
Medical DeviceAug 18, 2021
Stryker Medical Division of Stryker Electric MedSurg Bed FL23 - AC-powered adjustable recall — FDA Z-2222-2021
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
Class IIFDA: OngoingStryker Medical Division of Stryker Corporation
Medical DeviceAug 18, 2021
Integra LifeSciences CODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to recall — FDA Z-2224-2021
Packaging-pouches with wrinkles across the Tyvek side may compromise the integrity of the pouch's sterile barrier
Class IIFDA: TerminatedIntegra LifeSciences Corp.
Medical DeviceAug 18, 2021
Biomet Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM Item Number recall — FDA Z-2268-2021
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceAug 18, 2021
Beckman Coulter Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 recall — FDA Z-2256-2021
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
Class IIFDA: TerminatedBeckman Coulter Inc.
Medical DeviceAug 18, 2021
Stryker Medical Division of Stryker Surgistool-intended to support a healthcare professional recall — FDA Z-2206-2021
Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the…
Class IIFDA: OngoingStryker Medical Division of Stryker Corporation
Medical DeviceAug 18, 2021
HeartWare HVAD Implant Kit, REF MCS1705PU recall — FDA Z-2195-2021
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events…
Class IFDA: OngoingHeartware, Inc.
Medical DeviceAug 18, 2021
Biomet Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number recall — FDA Z-2261-2021
Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
Class IIFDA: TerminatedBiomet, Inc.
Medical DeviceAug 18, 2021
Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length recall — FDA Z-2282-2021
There is a potential for internal leaks within catheters.
Class IIFDA: TerminatedEdwards Lifesciences, LLC
Medical DeviceAug 18, 2021
BioFire Diagnostics FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label recall — FDA Z-2245-2021
Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
Class IIFDA: TerminatedBioFire Diagnostics, LLC
Medical DeviceAug 18, 2021
Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection recall — FDA Z-2237-2021
Due to high glucose test results when using the blood collection cards.
Class IIFDA: TerminatedAdvance Dx, Inc.
Medical DeviceAug 18, 2021
Bard Peripheral Vascular TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion recall — FDA Z-2249-2021
Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Class IIFDA: OngoingBard Peripheral Vascular Inc.
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.