FoodAug 21, 2024
Pariva Marinated Labneh Bites Rosemary Garlic recall — FDA F-1731-2024
Product may be contaminated with mold.
Class IIFDA: TerminatedPariva LLC
August 2024 recalls — page 7
These records include useful source details for the selected month.
VehicleAug 21, 2024
Chevrolet Silverado trailer hitch recall — NHTSA campaign 24V626000
OEM Systems, LLC (OEM) is recalling certain 2024 Chevrolet Silverado vehicles. The rear bumper mounting bracket may not be sufficient for towing, which can allow the towed trailer to detach…
trailer hitchOEM Systems, LLC
DrugAug 21, 2024
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles recall — FDA D-0632-2024
Defective container; yellow colored spike from cap lodged in the nozzle
Class IIFDA: OngoingFDC Limited
DrugAug 21, 2024
Taro Pharmaceuticals U.S.A Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle recall — FDA D-0633-2024
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained…
Class IIIFDA: CompletedTaro Pharmaceuticals U.S.A., Inc.
Medical DeviceAug 14, 2024
GE Medical Systems Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0 recall — FDA Z-2477-2024
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceAug 14, 2024
Smiths Medical ASD CADD-Solis VIP ambulatory Infusion Pumps, Model 2110 recall — FDA Z-2420-2024
The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space,…
Class IFDA: OngoingSmiths Medical ASD Inc.
Medical DeviceAug 14, 2024
American Contract Systems Gyn Laparoscopy convenience kit recall — FDA Z-2518-2024
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Class IIFDA: OngoingAmerican Contract Systems, Inc.
Medical DeviceAug 14, 2024
CareFusion 303 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version recall — FDA Z-2503-2024
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on…
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceAug 14, 2024
GE Medical Systems Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0 recall — FDA Z-2465-2024
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceAug 14, 2024
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station recall — FDA Z-2529-2024
An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.
Class IIFDA: OngoingLEICA BIOSYSTEMS NUSSLOCH GMBH
Medical DeviceAug 14, 2024
CareFusion 303 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software recall — FDA Z-2501-2024
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on…
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceAug 14, 2024
CareFusion 303 BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version recall — FDA Z-2492-2024
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on…
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceAug 14, 2024
Siemens Medical Solutions USA Multitom Rax -Intended to visualize anatomical structures by recall — FDA Z-2528-2024
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceAug 14, 2024
Smiths Medical ASD CADD-Solis Ambulatory Infusion Pumps, Model 2100 recall — FDA Z-2419-2024
CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsive, 3. Manual Mode Air…
Class IFDA: OngoingSmiths Medical ASD Inc.
Medical DeviceAug 14, 2024
CareFusion 303 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software recall — FDA Z-2488-2024
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on…
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceAug 14, 2024
Medline procedure kits labeled as: 1) CONTINUOUS BLOCK, Pack Number DYNJRA0960C recall — FDA Z-2442-2024
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a…
Class IFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceAug 14, 2024
Olympus Corporation of the Americas The Everest Bipolar Cutting Forceps are intended to be recall — FDA Z-2541-2024
Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
Class IIFDA: OngoingOlympus Corporation of the Americas
Medical DeviceAug 14, 2024
CareFusion 303 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version recall — FDA Z-2499-2024
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on…
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceAug 14, 2024
American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack recall — FDA Z-2521-2024
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Class IIFDA: OngoingAmerican Contract Systems, Inc.
Medical DeviceAug 14, 2024
GE Medical Systems SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0 recall — FDA Z-2460-2024
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceAug 14, 2024
American Contract Systems Cataract Pack convenience kit recall — FDA Z-2522-2024
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber
Class IIFDA: OngoingAmerican Contract Systems, Inc.
Medical DeviceAug 14, 2024
American Contract Systems Special Procedure Pack convenience kit recall — FDA Z-2520-2024
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Class IIFDA: OngoingAmerican Contract Systems, Inc.
Medical DeviceAug 14, 2024
GE Medical Systems SIGNA Prime, with affected software versions: MR30.1 recall — FDA Z-2479-2024
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two…
Class IIFDA: OngoingGE Medical Systems, LLC
Medical DeviceAug 14, 2024
American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract recall — FDA Z-2519-2024
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Class IIFDA: OngoingAmerican Contract 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.