Medical DeviceAug 4, 2021
GE Healthcare CARESCAPE PDM-Masimo SpO2 recall — FDA Z-2139-2021
Masimo SpO2 Saturation Values can become frozen after an extended length of use without a power down.
Class IIFDA: OngoingGE Healthcare, LLC
August 2021 recalls — page 11
These records include useful source details for the selected month.
Medical DeviceAug 4, 2021
Eight Medical International BV Recirculator 8.0s Disposable Lavage Kit recall — FDA Z-2005-2021
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
Class IFDA: TerminatedEight Medical International BV
Medical DeviceAug 4, 2021
CooperVision CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens with recall — FDA Z-2147-2021
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class IIFDA: TerminatedCooperVision Inc.
Medical DeviceAug 4, 2021
INNOVATIVE TOMOGRAPHY PRODUCT GMBH Coaxial Interventional Needle, ITP innotom.com, CE 0297 recall — FDA Z-2162-2021
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
Class IIFDA: OngoingINNOVATIVE TOMOGRAPHY PRODUCT GMBH
Medical DeviceAug 4, 2021
Sunrise Medical (US) Zippie Voyage, early intervention stroller - Product Usage: is manually recall — FDA Z-2157-2021
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
INNOVATIVE TOMOGRAPHY PRODUCT GMBH Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297 recall — FDA Z-2164-2021
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
Class IIFDA: OngoingINNOVATIVE TOMOGRAPHY PRODUCT GMBH
Medical DeviceAug 4, 2021
GE OEC Medical Systems OEC 3D Imaging, Image-Intensified Fluoroscopic X-Ray System, Mobile recall — FDA Z-2160-2021
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
Maquet Medical Systems USA Heater Cooler Unit (HCU 30) The device supplies recall — FDA Z-2140-2021
There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
Class IIFDA: TerminatedMaquet Medical Systems USA
Medical DeviceAug 4, 2021
Medtronic Vascular Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent recall — FDA Z-2135-2021
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 Power -07.00 -1.75/170 Daily Disposable Contact Lens with recall — FDA Z-2146-2021
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class IIFDA: TerminatedCooperVision Inc.
Medical DeviceAug 4, 2021
CooperVision CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens with recall — FDA Z-2150-2021
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 -07.00 -1.25/010 Daily Disposable Contact Lens with recall — FDA Z-2153-2021
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class IIFDA: TerminatedCooperVision Inc.
Medical DeviceAug 4, 2021
CooperVision AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens recall — FDA Z-2144-2021
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class IIFDA: TerminatedCooperVision Inc.
Medical DeviceAug 4, 2021
Remel ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United recall — FDA Z-2142-2021
Out of Specification
Class IIFDA: TerminatedRemel Inc.
Medical DeviceAug 4, 2021
CooperVision SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens recall — FDA Z-2148-2021
Misaligned placement of an axis mark can cause the patient to experience blurred vision
Class IIFDA: TerminatedCooperVision Inc.
Medical DeviceAug 4, 2021
Ion Beam Applications S.A Proteus 235-Proton Therapy System recall — FDA Z-2155-2021
if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated…
Class IIFDA: OngoingIon Beam Applications S.A.
Medical DeviceAug 4, 2021
B. Braun Medical Infusomat Space Volumetric Pump Administration Set, Product Code 490100 recall — FDA Z-2137-2021
There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the…
Class IIFDA: TerminatedB. Braun Medical, Inc.
Medical DeviceAug 4, 2021
Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290 recall — FDA Z-2159-2021
Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack labeling.
Class IIFDA: OngoingMedtronic Neuromodulation
FoodAug 4, 2021
NOW Health Group 2 lb bag, code 6295, UPC 733739062956, packed 8 bags per case recall — FDA F-0869-2021
Specific lot of Organic Steel Cut Oats, may actually contain Organic Beet Sugar
Class IIIFDA: TerminatedNOW Health Group Inc.
FoodAug 4, 2021
RANDALL BLACK BEANS 48OZ glass jars UPC 070095000605 recall — FDA F-0803-2021
Lack of functioning Temperature Indicating Devices in retorts
Class IIFDA: TerminatedRandall Foods, Inc.
FoodAug 4, 2021
Del Monte Foods Del Monte Fresh Cut Golden Sweet Whole Kernel Corn recall — FDA F-0808-2021
Firm discovered that some containers exhibited post-process spoilage during additional inspection and deployment of product at Distribution Center.
Class IIFDA: TerminatedDel Monte Foods, Inc.
FoodAug 4, 2021
RANDALL PINTO BEANS 48OZ glass jars UPC 070095000209 recall — FDA F-0799-2021
Lack of functioning Temperature Indicating Devices in retorts
Class IIFDA: TerminatedRandall Foods, Inc.
FoodAug 4, 2021
Old Souls Farms 1 oz, 10 lbs,25 lbs, 3 -1 lbs, 4 oz, and Living clamshells recall — FDA F-0862-2021
Positive rainwater test for Listeria monocytogenes. The rainwater came in contact with product.
Class IFDA: TerminatedOld Souls Farms LLC
FoodAug 4, 2021
RANDALL GARBANZO BEANS 24OZ glass jars UPC 070095000711 recall — FDA F-0804-2021
Lack of functioning Temperature Indicating Devices in retorts
Class IIFDA: TerminatedRandall Foods, 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.