DrugJul 27, 2022
Nephron Sterile Compounding Center Succinylcholine Chloride Injection, USP, 200 mg/10 mL recall — FDA D-1281-2022
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
July 2022 recalls — page 8
These records include useful source details for the selected month.
VehicleJul 21, 2022
Tacoma vehicle latch anchor recall — NHTSA campaign 22V520000
Toyota Motor Engineering & Manufacturing (Toyota) is recalling certain 2022-2023 Tacoma vehicles. One or more of the individual welds in the upper child seat anchors may be insufficient. As…
vehicle latch anchorToyota Motor Engineering & Manufacturing
VehicleJul 21, 2022
Nissan camera recall — NHTSA campaign 22V527000
Nissan North America, Inc. (Nissan) is recalling certain 2021-2022 Rogue, 2022 Frontier, Pathfinder, and Titan rental vehicles. When the Sirius XM subscription is set to "Not Subscribed,"…
cameraNissan North America, Inc.
VehicleJul 21, 2022
Toyota Motor Engineering & Manufacturing front passenger recall — NHTSA campaign 22V519000
Toyota Motor Engineering & Manufacturing (Toyota) is recalling certain 2022 Rav4, Rav4 Hybrid, and Rav4 Prime vehicles. The front passenger seat may have been assembled with interference…
front passengerToyota Motor Engineering & Manufacturing
VehicleJul 21, 2022
Model S frontal air bag recall — NHTSA campaign 22V526000
Tesla, Inc. (Tesla) is recalling certain 2022 Model S vehicles. The front bumper carrier structure may alter the vehicle's crash detection, causing the front passenger air bag to deploy…
frontal air bagTesla, Inc.
Medical DeviceJul 20, 2022
Cordis US PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System recall — FDA Z-1363-2022
Potential for stent dislodgement and associated failures related to two specific sizes of the device.
Class IIFDA: OngoingCordis US Corp
Medical DeviceJul 20, 2022
Medtronic MiniMed MiniMed 630G Insulin Pump (U.S. and Canada Version) recall — FDA Z-1353-2022
Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin…
Class IIFDA: OngoingMedtronic MiniMed
Medical DeviceJul 20, 2022
Ultradent Products Peak Universal Bond Self-Etch Bottle Kit, Part: 4541 recall — FDA Z-1368-2022
SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.
Class IIFDA: CompletedUltradent Products, Inc.
Medical DeviceJul 20, 2022
Waldemar Link GmbH & Co. KG Tibial Component. orthopedic prosthesis recall — FDA Z-1379-2022
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
Class IIFDA: OngoingWaldemar Link GmbH & Co. KG (Mfg Site)
Medical DeviceJul 20, 2022
Ortho-Clinical Diagnostics Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use recall — FDA Z-1367-2022
On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).
Class IIFDA: OngoingOrtho-Clinical Diagnostics, Inc.
Medical DeviceJul 20, 2022
Hamilton Medical AG HAMILTON-H900 Humidifier, Models: 950001, 950004 recall — FDA Z-1385-2022
When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the…
Class IIIFDA: CompletedHamilton Medical AG
Medical DeviceJul 20, 2022
Philips Medical Systems DMC GmbH DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy recall — FDA Z-1327-2022
Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first…
Class IIFDA: OngoingPhilips Medical Systems DMC GmbH
Medical DeviceJul 20, 2022
Medtronic MiniMed MiniMed 620G Insulin Pump (O.U.S. version) recall — FDA Z-1352-2022
Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin…
Class IIFDA: OngoingMedtronic MiniMed
Medical DeviceJul 20, 2022
DePuy Orthopaedics MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive recall — FDA Z-1375-2022
The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification…
Class IIFDA: OngoingDePuy Orthopaedics, Inc.
Medical DeviceJul 20, 2022
Waldemar Link GmbH & Co. KG Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis recall — FDA Z-1378-2022
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
Class IIFDA: OngoingWaldemar Link GmbH & Co. KG (Mfg Site)
Medical DeviceJul 20, 2022
Medtronic MiniMed MiniMed 770G Insulin Pump recall — FDA Z-1358-2022
Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin…
Class IIFDA: OngoingMedtronic MiniMed
Medical DeviceJul 20, 2022
Medtronic MiniMed MiniMed 780G Insulin Pump recall — FDA Z-1359-2022
Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin…
Class IIFDA: OngoingMedtronic MiniMed
Medical DeviceJul 20, 2022
Philips Medical Systems DMC GmbH DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and recall — FDA Z-1329-2022
Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first…
Class IIFDA: OngoingPhilips Medical Systems DMC GmbH
Medical DeviceJul 20, 2022
Agilent Technologies Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF recall — FDA Z-1384-2022
Label provided for substrate vail contained incorrect expiration date.
Class IIIFDA: OngoingAgilent Technologies, Inc.
Medical DeviceJul 20, 2022
Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal recall — FDA Z-1365-2022
The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.
Class IIFDA: OngoingDraeger Medical Systems, Inc.
Medical DeviceJul 20, 2022
Zeltiq Aesthetics CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000 recall — FDA Z-1347-2022
Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021…
Class IIFDA: OngoingZeltiq Aesthetics, Inc.
Medical DeviceJul 20, 2022
Medtronic MiniMed MiniMed 720G Insulin Pump recall — FDA Z-1356-2022
Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin…
Class IIFDA: OngoingMedtronic MiniMed
Medical DeviceJul 20, 2022
Breas Medical Vivo 45LS Ventilator- intended to provide continuous or intermittent recall — FDA Z-1382-2022
A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed,…
Class IIFDA: OngoingBreas Medical, Inc.
Medical DeviceJul 20, 2022
Fresenius Medical Care Holdings AquaBplus Water Purification System, Part Number 24-2000-0 recall — FDA Z-1364-2022
AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination…
Class IIFDA: TerminatedFresenius Medical Care Holdings, 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.