FDA Device recall Z-0233-2020

Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahe…

FDA Device
Class II
terminated
Published 2019-11-06

On 2019-11-06 the FDA classified a Class II recall of Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahe… by Convatec, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0233-2020
Classification	Class II
Status	terminated
Initiated	2019-09-06
Published	2019-11-06
Last updated	2026-09-13 11:55 UTC
Company	Convatec
Distribution	n/a

Product

Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3) Natura 4) Varicare Product Usage: stoma management

Reason

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.

Identifiers

code_info	1) Combihesive Natura Durahesive Product Code Lot Number 404592 7M00630 404592 8A06808 404592 8C04761 404593 7G02… 1) Combihesive Natura Durahesive Product Code Lot Number 404592 7M00630 404592 8A06808 404592 8C04761 404593 7G02852 404593 7L00138 404593 8B05257 404593 8E01304 404593 8E02335 404594 7G05697 404594 7H04921 404594 8A00742 404594 8D00595 404594 8E03028 404594 8G03932 125278 7L03070 125278 7L03072 125279 7K05187 125279 8F00670 125279 7E02312 125279 7K05185 125280 7D01173 125280 8A00732 125280 8E04640 125280 7D01171 125280 7D04717 125280 8A00735 125281 7C05398 125281 7K00519 125281 7K05908 125281 8E01678 125281 7C05397 125281 7E01838 125281 7K00520 125281 7L01343 125282 8H01556 125282 7G02896 125282 7M03979 125282 8H01557 125283 7C05414 125283 7M03583 125283 7H04122 125283 7L01045 125283 8J00539 125284 7H02189 125285 7J02058 125285 7D04718 125286 7H06313 125286 8A05991 125286 7F05915 125286 7H06312 125286 7J04227 125287 8A06017 125287 8D05101 125287 8A06018 125287 8D00709 125288 7M00469 125289 7G01364 125289 7K07047 125289 7G013

code_info

1) Combihesive Natura Durahesive Product Code Lot Number 404592 7M00630 404592 8A06808 404592 8C04761 404593 7G02…

1) Combihesive Natura Durahesive Product Code Lot Number 404592 7M00630 404592 8A06808 404592 8C04761 404593 7G02852 404593 7L00138 404593 8B05257 404593 8E01304 404593 8E02335 404594 7G05697 404594 7H04921 404594 8A00742 404594 8D00595 404594 8E03028 404594 8G03932 125278 7L03070 125278 7L03072 125279 7K05187 125279 8F00670 125279 7E02312 125279 7K05185 125280 7D01173 125280 8A00732 125280 8E04640 125280 7D01171 125280 7D04717 125280 8A00735 125281 7C05398 125281 7K00519 125281 7K05908 125281 8E01678 125281 7C05397 125281 7E01838 125281 7K00520 125281 7L01343 125282 8H01556 125282 7G02896 125282 7M03979 125282 8H01557 125283 7C05414 125283 7M03583 125283 7H04122 125283 7L01045 125283 8J00539 125284 7H02189 125285 7J02058 125285 7D04718 125286 7H06313 125286 8A05991 125286 7F05915 125286 7H06312 125286 7J04227 125287 8A06017 125287 8D05101 125287 8A06018 125287 8D00709 125288 7M00469 125289 7G01364 125289 7K07047 125289 7G013

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0233-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.