ConvaTec, Inc recalls DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds.…
Wound dressing may have foreign matter on the product.
Read the official notice →- Date
- 2025-10-22
- Country
- United States
- Brand
- ConvaTec
- Product
- DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds.…
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of OH, AL, AZ, CA, CO, 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
More ConvaTec recalls
- 2026-08-26
USConvaTec, Inc recalls Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705, 423707, 423708, 423709, 423710, 423712, 423713,…
Urostomy Pouches may leak from cap during use.
FDA · DeviceConvaTec, IncUS Nationwide distribution including in the states of AR, AZ, CA, CO, DC, DE,…Official notice →- 2026-07-15
- US
ConvaTec, Inc recalls Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
Surgical dressing manufactured out of specification (greater thickness).
FDA · DeviceConvaTec, IncUS Nationwide distribution in the states of MD, OH, IL, NC, AZ, NY, MN, TX,…Official notice → - 2026-03-25
- US
ConvaTec, Inc recalls Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Drainable large pouch may leak due to manufacturing issue.
FDA · DeviceConvaTec, IncWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - 2025-01-22
- US
ConvaTec, Inc recalls Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier…
Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is…
- 2024-04-17
- US
ConvaTec, Inc recalls ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5…
The product does not meet sterility assurance level.
FDA · DeviceConvaTec, IncUS Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.Official notice → - 2024-03-27
- US
ConvaTec, Inc recalls Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645,…
Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.
FDA · DeviceConvaTec, IncWorldwide distribution - US Nationwide and the countries of Italy, UK.Official notice →
Other drugs & medical recalls in the United States
- 2025-10-22
- US
American Contract Systems Inc. recalls Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991…
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to…
FDA · DeviceAmerican Contract Systems Inc.US Nationwide distribution in the states of SD, IA, MN, WA, IL.Official notice → - US
Spacelabs Healthcare, Inc. recalls Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software…
Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of…
FDA · DeviceSpacelabs Healthcare, Inc.Worldwide - United States Nationwide distribution including in the states of…Official notice → - US
Philips North America recalls Cardiac Workstation 5000; Model Number: 860439;
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
FDA · DevicePhilips North AmericaUS Nationwide distribution in the states of CA, IA, TN, TX, VA.Official notice → - US
Fisher & Paykel Healthcare, Ltd. recalls Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user…
FDA · DeviceFisher & Paykel Healthcare, Ltd.US Nationwide distribution including in the states of TX, MS, LA, NC, TN, NY,…Official notice → - US
GE Medical Systems, LLC recalls LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
- US
BioPro, Inc. recalls BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM…
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.