Complete FDA and NHTSA recall records dated in September 2023.
These records include useful source details for the selected month.
Chrysler (FCA US, LLC) is recalling certain 2022-2023 Ram 1500, Ram 3500 Cab Chassis with GVWR less than 10,000 lbs., and 2022-2024 Ram 2500 vehicles. The radio software may prevent the…
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation…
Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to…
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged…
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as…
A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could reach elevated temperatures and fail, then power off and become inoperable.
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the…
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the…
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the…
One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the…
Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption…
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose…
Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors, informing users a 60-100 second…
Degrading capacitors on the control board of ventilators and spare parts may leak electrolyte onto the control board causing a short circuit on the board and/or the capacitor to lose…
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged…
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged…
An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated Insulin Delivery System from…
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.
