Defibtech, LLC recalls Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on…
Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead…
Read the official notice →- Date
- 2024-12-04
- Country
- United States
- Brand
- Defibtech
- Product
- Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX Series)- Indicated for use on…
- Classification
- Class II
- Units
- Ireland
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Defibtech recalls
- 2025-05-07
USDefibtech, LLC recalls Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1…
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in…
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Defibtech, LLC recalls Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View…
Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could…
- 2024-08-21
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Defibtech, LLC recalls RMU-2000 Automated Chest Compression Device
Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death.
FDA · DeviceDefibtech, LLCDomestic distribution to CT, FL, NJ, SC, TN. Foreign distribution to JapanOfficial notice → - 2023-04-05
- US
Defibtech, LLC recalls DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.
Other drugs & medical recalls in the United States
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MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON…
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide. Bermuda, Canada, Panama, UAE, US Virgin IslandsOfficial notice → - US
KCI USA, INC. recalls V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound Therapy System is an integrated wound…
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FDA · DeviceKCI USA, INC.Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, FL,…Official notice → - US
Defibtech, LLC recalls Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro, lifeline ECG, lifeline View…
Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could…
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Hologic, Inc recalls BioZorb Marker. Radiographic soft tissue marker.
Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
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Neogen Corporation recalls LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) per sachet, Distributed By: Bob Barker Company, Inc., 7925…
CGMP violations.
FDA · DrugNeogen CorporationProduct sold directly to one distributor consignee, Bob Barker Company, an…Official notice →