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.
Read the official notice →- Date
- 2024-03-27
- Country
- United States
- Brand
- ConvaTec
- Product
- Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645,…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Italy, UK.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-10-22
US
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.
FDA · DeviceConvaTec, IncUS Nationwide distribution including in the states of OH, AL, AZ, CA, CO, FL,…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 →- 2024-03-13
US
ConvaTec, Inc recalls ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
FDA · DeviceConvaTec, IncDistribution was made to AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, and TX.…Official notice →- 2022-12-28
US
ConvaTec, Inc recalls ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings.
- 2022-11-02
US
ConvaTec, Inc recalls ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a…
impaired functionality of the release liner
Other drugs & medical recalls in the United States
- 2024-04-03
US
US
Amneal Pharmaceuticals of New York, LLC recalls Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals…
Failed dissolution specifications
FDA · DrugAmneal Pharmaceuticals of New York, LLCProduct was distributed nationwide.Official notice →US
- 2024-03-27
US
Landauer recalls microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000,…
Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove all reference to use of the microStar readers with the nanoDot or any otherbdosimeter for medical…
FDA · DeviceLandauerWorldwide distribution - United States Nationwide and the countries of…Official notice →US
Angiodynamics, Inc. recalls MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system.…
Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the…
FDA · DeviceAngiodynamics, Inc.Worldwide distribution - US Nationwide and the countries of AT, CA, CH, CZ,…Official notice →US
D.O.R.C. Dutch Opthalmic Research Center Intl B.V. recalls Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
When using those products you may experience difficulties to extend or retract the laser fiber, and in some occasions may also have difficulties to direct the laser fiber tip precisely.
FDA · DeviceD.O.R.C. Dutch Opthalmic Research Center Intl B.V.US Nationwide distribution in the states of AZ, CO, FL, IN, MD, NC, NY, OH,…Official notice →