FoodAug 11, 2021
USA 7 Eleven Selects Chocolate Chip 3pack Mini Muffins - 2.6 oz recall — FDA F-0827-2021
May be contaminated with Listeria monocytogenes
Class IIFDA: TerminatedGIVE AND GO PREPARED FOODS (USA)
August 2021 recalls — page 10
These records include useful source details for the selected month.
DrugAug 11, 2021
Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing recall — FDA D-0700-2021
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Class IIFDA: OngoingPfizer Inc.
DrugAug 11, 2021
Qikmoov Vy&Tea recall — FDA D-0749-2021
Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.
Class IFDA: OngoingQikmoov LLC
DrugAug 11, 2021
Cascade Kelly Holdings Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80% recall — FDA D-0697-2021
CGMP Deviations: Does not meet monograph for denaturant.
Class IIFDA: TerminatedCascade Kelly Holdings LLC
DrugAug 11, 2021
Cascade Kelly Holdings Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80% recall — FDA D-0698-2021
CGMP Deviations: Does not meet monograph for denaturant.
Class IIFDA: TerminatedCascade Kelly Holdings LLC
VehicleAug 10, 2021
Ford control/drive module recall — NHTSA campaign 21V625000
Ford Motor Company (Ford) is recalling certain 2021 Escape, Lincoln Corsair, and 2021-2022 Bronco Sport vehicles. The fuel delivery module may leak inside the fuel tank, causing low fuel…
control/drive moduleFord Motor Company
VehicleAug 6, 2021
Taos engine control module (ecu/ecm) software recall — NHTSA campaign 21V615000
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2022 Taos vehicles equipped with all-wheel drive. The engine control unit (ECU) software may cause a stall when coming to…
engine control module (ecu/ecm) softwareVolkswagen Group of America, Inc.
VehicleAug 5, 2021
Volkswagen Group of retractor recall — NHTSA campaign 21V606000
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2021 Volkswagen ID4, Audi A4 Allroad, A4 Sedan, A5 Cabriolet, A5 Coupe, A5 Sportback, A6 Allroad, A6 Sedan, A7, A8,…
retractorVolkswagen Group of America, Inc.
VehicleAug 5, 2021
General Motors tires recall — NHTSA campaign 21V612000
General Motors, LLC (GM) is recalling certain 2021-2022 Chevrolet Equinox and GMC Terrain vehicles equipped with certain Hankook tires. The tires may have been manufactured with an…
tiresGeneral Motors, LLC
Medical DeviceAug 4, 2021
GE OEC Medical Systems OEC Elite mobile C-arm - Product Usage: intended to provide recall — FDA Z-2161-2021
There is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable.
Class IIFDA: TerminatedGE OEC Medical Systems, Inc.
Medical DeviceAug 4, 2021
CooperVision CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens with recall — FDA Z-2143-2021
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class IIFDA: TerminatedCooperVision Inc.
Medical DeviceAug 4, 2021
CooperVision FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens with recall — FDA Z-2145-2021
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class IIFDA: TerminatedCooperVision Inc.
Medical DeviceAug 4, 2021
CooperVision SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable Contact recall — FDA Z-2154-2021
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class IIFDA: TerminatedCooperVision Inc.
Medical DeviceAug 4, 2021
Hill-Rom Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in recall — FDA Z-2156-2021
Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperly engaged onto the bed, could…
Class IIFDA: TerminatedHill-Rom, Inc.
Medical DeviceAug 4, 2021
Southmedic OxyMask O2 Adult REF OM-1125-14 recall — FDA Z-2141-2021
Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of…
Class IIFDA: OngoingSouthmedic, Inc.
Medical DeviceAug 4, 2021
Sunrise Medical (US) Zippie Voyage, early intervention stroller - Product Usage: is manually recall — FDA Z-2158-2021
The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.
Class IIFDA: TerminatedSunrise Medical (US) LLC
Medical DeviceAug 4, 2021
CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. recall — FDA Z-2134-2021
The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.
Class IIFDA: TerminatedCytocell Ltd.
Medical DeviceAug 4, 2021
INNOVATIVE TOMOGRAPHY PRODUCT GMBH Coaxial Interventional Needle, ITP innotom.com, CE 0297 recall — FDA Z-2163-2021
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
Class IIFDA: OngoingINNOVATIVE TOMOGRAPHY PRODUCT GMBH
Medical DeviceAug 4, 2021
CooperVision CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Lens with recall — FDA Z-2152-2021
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class IIFDA: TerminatedCooperVision Inc.
Medical DeviceAug 4, 2021
RAYSEARCH LABORATORIES AB RayStation recall — FDA Z-2138-2021
Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceAug 4, 2021
CooperVision MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens recall — FDA Z-2151-2021
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class IIFDA: TerminatedCooperVision Inc.
Medical DeviceAug 4, 2021
Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF recall — FDA Z-2136-2021
During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
Class IIFDA: OngoingMedtronic Vascular, Inc.
Medical DeviceAug 4, 2021
CooperVision CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposable Contact recall — FDA Z-2149-2021
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class IIFDA: TerminatedCooperVision Inc.
Medical DeviceAug 4, 2021
Merit Medical Systems basixALPHA Inflation Device 30 atm/bar 20 mL - Product Usage: Used to recall — FDA Z-2166-2021
Due to a design issue, inflation syringe handle separating from the inflation device when handle is withdrawn.
Class IIFDA: TerminatedMerit Medical Systems, 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.