Hamilton Medical AG recalls IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.
Read the official notice →- Date
- 2026-07-08
- Country
- United States
- Brand
- Hamilton Medical
- Product
- IntelliCuff, Portable automatic cuff pressure controller REF: 951001
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Hamilton Medical recalls
- 2026-07-08
USHamilton Medical AG recalls Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may…
FDA · DeviceHamilton Medical AGUS Nationwide distribution including in the states of KS, WA, VT, TX, WI, AR,…Official notice →- 2025-08-27
- US
Hamilton Medical AG recalls Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive…
A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device…
- 2025-08-06
- US
Hamilton Medical AG recalls Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and…
Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete…
FDA · DeviceHamilton Medical AGUS Nationwide distribution in the states of NH, NY, CT, PA, IL, ME, CO, NC,…Official notice → - 2024-06-26
- US
Hamilton Medical AG recalls Ventilator HAMILTON-C6, PN: 160021
Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube…
FDA · DeviceHamilton Medical AGUS Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR,…Official notice → - 2023-09-27
- US
Hamilton Medical, Inc. recalls Hamilton C1/T1/MR1, REF: MSP161502/12, Control Board Spare part for ventilator
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 function and lead to interruption…
FDA · DeviceHamilton Medical, Inc.Distribution US nationwide, including Puerto Rico. OUS: Not providedOfficial notice → - 2023-08-02
- US
Hamilton Medical, Inc. recalls HAMILTON C3 Ventilator REF 160005 Is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally…
Due to a software anomaly after approximately 91 days of cumulative use, the ventilator may stop and enter the ambient mode without prior notice.
FDA · DeviceHamilton Medical, Inc.U.S.: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware…Official notice →
Other drugs & medical recalls in the United States
- 2026-07-08
- US
TELEFLEX LLC recalls Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton)…
Due to out-of-specification, or potential out-of-specification, levels of endotoxins
FDA · DeviceTELEFLEX LLCWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - US
Baxter Healthcare Corporation recalls Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back…
The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating…
FDA · DeviceBaxter Healthcare CorporationWorldwide - US Nationwide distribution in the states of Minnesota, Maryland,…Official notice → - US
Boston Scientific Corporation recalls CRE Pro Wireguided 12-15mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Medtronic Heart Valves Division recalls Medtronic Harmony Delivery Catheter System
Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a…
FDA · DeviceMedtronic Heart Valves DivisionWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
Remel, Inc recalls GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
FDA · DeviceRemel, IncWorldwide distribution - US Nationwide and the countries of Canada, Singapore,…Official notice → - US
Windstone Medical Packaging, Inc. recalls A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
FDA · DeviceWindstone Medical Packaging, Inc.US Nationwide distribution in the states of PA, GA, CA, WA.Official notice →