Convatec Inc.

Complete recall history across all FDA and CPSC categories — 9 total recalls

Convatec Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (9)

FDA medical device enforcement actions by Convatec Inc.

Date Product Reason Class
Apr 29, 2014 Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 ... Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have ... Class I
Feb 7, 2014 Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Pr... The lumen of the Medline Sterile Foley Catheter was found to be blocked by ex... Class II
Feb 7, 2014 Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD1191... The lumen of the Medline Sterile Foley Catheter was found to be blocked by ex... Class II
Feb 7, 2014 SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Us... The lumen of the Medline Sterile Foley Catheter was found to be blocked by ex... Class II
Feb 7, 2014 'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: L... The lumen of the Medline Sterile Foley Catheter was found to be blocked by ex... Class II
Feb 7, 2014 SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Late... The lumen of the Medline Sterile Foley Catheter was found to be blocked by ex... Class II
Feb 7, 2014 JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Fol... The lumen of the Medline Sterile Foley Catheter was found to be blocked by ex... Class II
Jun 25, 2013 ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage:... ConvaTec notified their customers on 6/25/2013 regarding the manufacturing ir... Class III
Jun 25, 2013 ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage f... ConvaTec notified their customers on 6/25/2013 regarding the manufacturing ir... Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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