DRE Medical Group Inc recalls Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage…
Devices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may pose a serious health risk as the gas pathway of these devices may be contaminated.
Read the official notice →- Date
- 2023-07-05
- Country
- United States
- Brand
- DRE Medical Group Inc
- Product
- Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage…
- Classification
- Class II
- Units
- US: CA, FL
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
Other drugs & medical recalls in the United States
- 2023-07-05
USImplant Direct Sybron Manufacturing LLC recalls LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW…
Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
FDA · DeviceImplant Direct Sybron Manufacturing LLCUS Nationwide distribution in the states of FL, ID, TX, CA.Official notice →- US
Medtronic Neuromodulation recalls Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue…
- US
Hologic, Inc recalls Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
- US
Luminex Corporation recalls VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result…
- US
Randox Laboratories Ltd. recalls Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of…
Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch…
- US
Tornier, Inc recalls AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short…
FDA · DeviceTornier, IncWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice →