Covidien Llc recalls Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Read the official notice →- Date
- 2021-12-15
- Country
- United States
- Brand
- Covidien
- Product
- Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
- Classification
- Class I
- Units
- Worldwide distribution - US Nationwide.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
More Covidien recalls
- 2022-07-13
USCovidien Llc recalls Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis,…
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
FDA · DeviceCovidien LlcWorldwide distribution - US Nationwide distribution in the states of AK, AL,…Official notice →- 2022-02-09
- US
Covidien Llc recalls Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular.…
The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the…
FDA · DeviceCovidien LlcWorldwide distribution - US Nationwide and the countries of Germany, Israel,…Official notice → - 2022-01-26
- US
Covidien, LP recalls SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001. used with endotracheal tube (ETT)
Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely detected a sensor cable disconnect and reconnect during setup. The monitor detection of a false sensor cable…
FDA · DeviceCovidien, LPThe devices were distributed to the following US states: CA, CO, FL, IL, KY,…Official notice → - 2022-01-19
- US
Covidien Llc recalls LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding,…
FDA · DeviceCovidien LlcWorldwide Distribution in the countries of Australia, Austria, Belgium, Czech…Official notice → - 2021-12-15
- US
Covidien Llc recalls Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery…
Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit
- 2021-11-17
- US
Covidien Llc recalls Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with…
FDA · DeviceCovidien LlcNo domestic distribution. Foreign distribution to Hong Kong and UK.Official notice →
Other drugs & medical recalls in the United States
- 2021-12-22
- US
Preferred Pharmaceuticals, Inc. recalls Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred…
Defective container: Out of specification for container integrity leading to bottles leaking.
FDA · DrugPreferred Pharmaceuticals, Inc.Distributed to 5 physician consignees located in the following states: CT, FL,…Official notice → - 2021-12-15
- US
Philips North America Llc recalls BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result…
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice → - US
Argon Medical Devices, Inc recalls SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERCORE BIOPSY INSTR…
Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.
FDA · DeviceArgon Medical Devices, IncWorldwide distribution - U.S. Nationwide distribution in the states of AK, AL,…Official notice → - US
Osteomed, LLC recalls OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF…
Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
FDA · DeviceOsteomed, LLCWorldwide distribution - U.S. Nationwide distribution in the states of AL, AR,…Official notice → - US
Orchestrate Orthodontic Technologies, Inc. recalls O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth…
Due to product label/labeling being altered from it's approved state.
FDA · DeviceOrchestrate Orthodontic Technologies, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR,…Official notice → - US
Northgate Technologies, Inc. recalls Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with…
The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.