Collector, Ostomy
Gastroenterology, Urology · 21 CFR 876.5900
Recent MDR events
543 adverse event reports on file
- NEW IMAGEJul 10, 2026InjuryHollister Incorporated1119193-2026-00049
- MODERMAFLEX OSTOMY APPLIANCEJun 15, 2026InjuryHollister Incorporated3016675012-2026-00004
- PREMIERMay 7, 2026InjuryHollister Incorporated1119193-2026-00040
- NEW IMAGEApr 15, 2026InjuryHollister Incorporated1119193-2026-00036
- NEW IMAGEApr 15, 2026InjuryHollister Incorporated1119193-2026-00038
- CERAPLUS ONE-PIECE SOFT CONVEX POUCHMar 17, 2026InjuryHollister Incorporated1119193-2026-00017
- PREMIERMar 16, 2026InjuryHollister Incorporated1119193-2026-00016
- NEW IMAGE BARRIERFeb 24, 2026InjuryHollister Incorporated1119193-2026-00013
- NEW IMAGE BARRIERFeb 17, 2026InjuryHollister Incorporated1119193-2026-00011
- CERAPLUS BARRIER RINGFeb 10, 2026InjuryHollister Incorporated1119193-2026-00009
Event type breakdown
Recalls
5 recall events for this product code
- Convatec Inc.TerminatedOct 5, 2011
Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm)
Post-operative kits 57 mm may contain 70 mm pouches.
Z-0013-2012 · View FDA record ↗ - Coloplast Manufacturing US, LLCTerminatedSep 9, 2011
Coloplast Corp.-MN 06093, Country of origin: DK ( SenSura 19011 Post-Op, ostomy bag with window, 100 mm , Sterilized using ethylene oxide; SenSura 19010 Post-
On July 19, 2011 Coloplast became aware of the failure or routine sterility testing for one lot of SenSuera and Assura Post-Op Ostomy Bags. Based on these results it was determined that all affected lots be recalled and quarantined. This affects lots manufactured and distributed from January 2010 until July 19, 2011.
Z-3174-2011 · View FDA record ↗ - Convatec Inc.TerminatedMar 8, 2011
Natura Durahesive ConvaTec Moldable Technology Post-Operative/Surgical System (57mm), 2 1/4 inch
Natura Durahesive ConvaTec Moldable Technology Post Operative/Surgical System (57mm) units may contain pouches with 45 mm Natura flanges, therefore the pouch, low pressure adapter and barrier would not fit together.
Z-1610-2011 · View FDA record ↗ - ConvaTecTerminatedJul 2, 2008
GentleTouch System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm; ConvaTec, Skillman, NJ 0
Mislabeled: The carton label reads "For postsurgical use following a urostomy procedure." It should read "For postsurgical use following a colostomy or ileostomy procedure."
Z-1314-2008 · View FDA record ↗ - ConvaTecTerminatedMay 7, 2008
Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Order Number 020917, Nypro Dominican Republ
Mislabeled: The market unit carton label reads 5/8 - 1 inch, and it should read 5/16 - 1 inch. The metric units (8-25mm) on the label are correct.
Z-1179-2008 · View FDA record ↗
Registered firms
101 firms currently registered for this product code
Innopex Limited
Toronto Ontario, CA
Kosemed Ortopedi Sanayi Ve Ticaret Ithalat Ihracat Anonim Sirketi
Salihli Manisa, TR
C.r. Bard, Inc.
MADISON, GA, US
C.r. Bard, Inc.
COVINGTON, GA, US
Oketz Logistics Llc
Coral Gables, FL, US
Mainline Medical Dental Supply
North York Ontario, CA
Jiangsu Wld Medical Co., Ltd.
YIZHENG Jiangsu, CN
Hollister Incorporated
STUARTS DRAFT, VA, US
Nuance Medical, Llc
Carlsbad, CA, US
Dongguan Hong De Medical Plastic Products Co. Ltd.
Dongguan Guangdong, CN
Lumaclean, Llc
Concord, NC, US
Wenzhou Zuoyou Medical Technoloyg Co.,ltd.
Wenzhou Zhejiang, CN
Pdi Emea Ltd
Corby Northamptonshire, GB
Coloplast Hungary, Kft
Tatabanya, HU
Jiangsu Ostup Medical Products Co. Ltd.
Nanjing Jiangsu, CN
Hubei Hendry Medical Appliance Co., Ltd
Xiaogan City Hubei, CN
Hangzhou Rollmed Co.,ltd.
Hangzhou Zhejiang, CN
Coloplast A/s
HUMLEBAEK Hovedstaden, DK
Sarasota Medical Products
Sarasota, FL, US
Casex, Ltda
Curitiba Parana, BR
Dylan Lucas International Inc
Vaughan Ontario, CA
Coloplast Hungary Kft
TATABANYA Komarom-Esztergom, HU
Coloplast A/s - Mordrup Site
Espergaerde Hovedstaden, DK
Isomedix Operations Inc
El Paso, TX, US
510(k) clearances
102 clearances for this product code
- Coloplast Corp.Oct 6, 2025
K252140 · Heylo System
- 11 Health Technologies LimitedNov 16, 2018
K181643 · SmartBag (SmartPouch)
- 11 Health and Technologies, LLCOct 10, 2014
K140938 · OSTOM-I ALERT
- Lake Medical Products, Inc.Dec 30, 1993
K922730 · LAKE OSTOMY CARE SET
- Cdc Products Corp.Dec 8, 1988
K882878 · ODOR-END EMERGENCY CLEAN UP POWDER
- Coloplast A/SJul 13, 1988
K881636 · CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)
- Cdc Products Corp.May 20, 1988
K880306 · EMERGENCY-CLEAN UP(TM) ECP
- Arnold TechnologiesDec 29, 1987
K872294 · COMBINATION NITE DRAINAGE UNIT