UNOMEDICAL S.R.O.

22 recall(s) on record — most severe on record: Class I.

Devices registered here (1)

• Bag, Urinary, Ileostomy
  Product code EXH · Class I · Gastroenterology, Urology · 21 CFR 876.5900

Recalls & enforcement

• Class IIOngoing2026-06-08
  Surgical dressing manufactured out of specification (greater thickness).
• Class IIOngoing2026-02-16
  Drainable large pouch may leak due to manufacturing issue.
• Class IIOngoing2025-08-29
  Wound dressing may have foreign matter on the product.
• Class IIOngoing2024-11-29
  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 too small and the device user tries to apply, this could cause
• Class IIOngoing2024-02-27
  The product does not meet sterility assurance level.
• Class IIOngoing2024-02-19
  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.
• Class IIOngoing2024-01-17
  The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
• Class IIOngoing2022-11-15
  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.
• Class IIOngoing2022-08-16
  impaired functionality of the release liner
• Class IITerminated2022-04-22
  Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
• Class IIOngoing2021-08-20
  Primary packaging labeling may be incorrect.
• Class IIOngoing2021-08-09
  There is a potential for open seals which can compromise sterility.
• Class IITerminated2019-09-06
  ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to September 2018. FDA became aware of this problem via routine MDR monitoring.
• Class IIOngoing2019-01-09
  An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
• Class IITerminated2018-07-03
  Bubble Leak Testing on AbViser AutoValve IAP Monitoring Devices without Transducer confirmed the potential for a pinhole breach in the sterile barrier.
• Class IITerminated2018-04-25
  It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label.
• Class IITerminated2017-10-26
  A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) were incorrectly labeled as Natura Moldable Stomahesive Skin Barrier (10 pack, 45 mm, REF 411803).
• Class IITerminated2017-05-10
• Class IITerminated2015-11-11
  The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer.
• Class ITerminated2014-04-29
  Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal assessment of product performance, including a review of customer feedback, has confirmed that Flexi-Seal Control is not meeting expectations or those of customers. Spec
• Class IITerminated2014-02-07
  The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
• Class IIITerminated2013-06-25
  ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occurred related to the packaging of certain lots of Flexi-Seal Signal FMS. In certain lots, the lot number convention was duplicated on the packaging.

Related

• All facilities operated by ConvaTec
• ConvaTec Canada Ltd. (CA)
• CONVATEC LIMITED (GB)
• ConvaTec Limited, GDC Building (GB)
• ConvaTec, Inc. (NC)
• CONVATEC DOMINICAN REPUBLIC, INC. (DO)

Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →