Vygon Corp.

Also registered as Vygon Corporation, Vygon SA

Country not established

Devices: 1,231
FDA recalls: 23

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

What Vygon Corp. makes

The company manufactures intravenous administration tubing extension sets, nasogastric feeding tubes, and vascular catheterization support/maintenance kits for non-medicated use. It also produces vascular catheter introduction sets (nonimplantable), vascular port administration sets, and peripheral intravenous catheterization support kits. Single-use ENFit oral/enteral syringes and peripherally-inserted central venous catheters are part of its portfolio.

These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1,231

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FDA recalls23

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 23 recalls initiated by Vygon Corp., the earliest on 2003-04-09 and the most recent on 2014-08-28. By recorded status: 23 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Showing the 10 most recent of 23 recalls.

2014
- 28 Aug 2014 Z-0113-2015 Class II Terminated Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector. Distribution: Worldwide Distribution - US including CA and Internationally to CA. Submission number: K070705
2012
- 17 Dec 2012 Z-0937-2013 Class II Terminated Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle. Distribution: Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania Submission number: K081904
- 11 May 2012 Z-1797-2012 Class II Terminated Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Distribution: Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA,…
  Full distribution text
  Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
  Submission number: K061497
- 11 May 2012 Z-1798-2012 Class II Terminated Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Distribution: Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA,…
  Full distribution text
  Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
  Submission number: K061497
- 11 May 2012 Z-1799-2012 Class II Terminated Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Distribution: Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA,…
  Full distribution text
  Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
  Submission number: K061497
- 11 May 2012 Z-1800-2012 Class II Terminated Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Distribution: Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA,…
  Full distribution text
  Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
  Submission number: K061497
- 11 May 2012 Z-1801-2012 Class II Terminated Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Distribution: Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA,…
  Full distribution text
  Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
  Submission number: K061497
- 11 May 2012 Z-1802-2012 Class II Terminated Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Distribution: Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA,…
  Full distribution text
  Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
  Submission number: K061497
- 11 May 2012 Z-1803-2012 Class II Terminated Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Distribution: Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA,…
  Full distribution text
  Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
  Submission number: K061497
- 11 May 2012 Z-1804-2012 Class II Terminated Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Distribution: Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA,…
  Full distribution text
  Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
  Submission number: K061497

Show all 23 recalls

2012
- 11 May 2012 Z-1805-2012 Class II Terminated Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Distribution: Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA,…
  Full distribution text
  Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
  Submission number: K061497
- 11 May 2012 Z-1806-2012 Class II Terminated Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Distribution: Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA,…
  Full distribution text
  Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
  Submission number: K061497
- 11 May 2012 Z-1807-2012 Class II Terminated Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Distribution: Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA,…
  Full distribution text
  Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
  Submission number: K061497
- 11 May 2012 Z-1808-2012 Class II Terminated Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes. Distribution: Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA,…
  Full distribution text
  Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.
  Submission number: K061497
2011
- 26 Apr 2011 Z-2699-2011 Unclassified (pre-2012) Terminated Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration. Distribution: Nationwide Distribution--USA including states of: AZ, CA, FL, MO, NE, NJ, NY, PA, TX, UT, VA, and WA. Submission number: K062425
- 26 Apr 2011 Z-2700-2011 Unclassified (pre-2012) Terminated Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration. Distribution: Nationwide Distribution--USA including states of: AZ, CA, FL, MO, NE, NJ, NY, PA, TX, UT, VA, and WA. Submission number: K062425
- 19 Apr 2011 Z-2388-2011 Unclassified (pre-2012) Terminated Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination. Distribution: United States (FL, MA, MD, and VA).
- 19 Apr 2011 Z-2389-2011 Unclassified (pre-2012) Terminated Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination. Distribution: United States (FL, MA, MD, and VA).
- 19 Apr 2011 Z-2390-2011 Unclassified (pre-2012) Terminated Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination. Distribution: United States (FL, MA, MD, and VA).
- 19 Apr 2011 Z-2391-2011 Unclassified (pre-2012) Terminated Skin-Prep wipes purchased by Churchill (a Vygon company) for inclusion into Dressing Kits and PICC Insertion Kits were recalled by the manufacturer due to potential bacterial contamination. Distribution: United States (FL, MA, MD, and VA).
2005
- 27 Jun 2005 Z-0090-06 Unclassified (pre-2012) Terminated Guidewire protuding from tip of the catheter Distribution: The product was shipped to distributors in CA, CO, FL, IL, MD, NJ, NY, OH, PA, TX and WA. Submission number: K041468
2003
- 9 Apr 2003 Z-0849-03 Unclassified (pre-2012) Terminated Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath. Distribution: Product was only distributed domestically to customers and sales representatives in MA, NY, GA, FL, OH, CO, and CA.…
  Full distribution text
  Product was only distributed domestically to customers and sales representatives in MA, NY, GA, FL, OH, CO, and CA. There are no Govt. accounts.
  Submission number: K954112
- 9 Apr 2003 Z-0850-03 Unclassified (pre-2012) Terminated Nutriline with Peelable Sheath 2 Fr. and Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. insertion sheath. Distribution: Product was only distributed domestically to customers and sales representatives in MA, NY, GA, FL, OH, CO, and CA.…
  Full distribution text
  Product was only distributed domestically to customers and sales representatives in MA, NY, GA, FL, OH, CO, and CA. There are no Govt. accounts.
  Submission number: K954112

Frequently asked questions

How many devices does Vygon Corp. have in the registry?

The registry currently lists 1231 devices for Vygon Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Vygon Corp.'s devices?

Among its 50 most recently registered devices, Vygon Corp. has devices listed in FDA GUDID (50 devices).

What risk classes do Vygon Corp.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Vygon Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Vygon Corp.?

FDA recall records list 23 recalls initiated by Vygon Corp., the most recent initiated on 28 Aug 2014. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Vygon Corp. in the registry?

The most recently registered devices listed for Vygon Corp. include VYGON AMS-7203CP, VYGON PIP210200T, VYGON PIP200000T and VYGON PIP200100T.

Generated automatically from registry data and not verified by a human reviewer.