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Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

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

Vygon MFG, Inc., dba/ Churchill Medical Systems, 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 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

Date Product Reason Class
Sep 24, 2019 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001 Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr f... Class II
Oct 3, 2017 Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. ... The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stabilit... Class II
Jul 24, 2017 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034. Vygon is conducting a voluntary recall of the products and lots listed in thi... Class II
Jul 24, 2017 Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M Vygon is conducting a voluntary recall of the products and lots listed in thi... Class II
Jul 24, 2017 CVC Tray Pediatrics. Product Code: AMS-9335CP-2. Vygon is conducting a voluntary recall of the products and lots listed in thi... Class II
Jul 24, 2017 19Ga x 1 Huber Needle Set. Product Code: MBS-1910. Vygon is conducting a voluntary recall of the products and lots listed in thi... Class II
Jul 24, 2017 3-Way Standardbore Stopcock. Product Code: AMS-100. Vygon is conducting a voluntary recall of the products and lots listed in thi... Class II
Feb 20, 2017 AMS-636, 60" Microbore extension set. Product Usage: Accessory devices us... Incorrect priming volume printed on the device package. Class II
Nov 18, 2016 AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651... Incorrect priming volume is printed on the device package. Class II

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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