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Deltec, Inc.

United StatesFDA applicant, unverified

Devices
5
FDA recalls
28

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Deltec, Inc. makes

Deltec, Inc. manufactures infusion and dialysis devices, including high-volume administration sets with flow control, insulin infusion pumps and their accessories, and dual-lumen polyurethane catheters for long-term and short-term hemodialysis. Their product line also includes specialized needles, such as the Gripper Plus, designed for medical procedures. These devices are intended for use in clinical settings requiring precise fluid administration or vascular access.

The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) clearance process. These products are intended for use in the United States, where Deltec, Inc. is based. No additional regulatory listings outside the FDA are referenced in their device portfolio.

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

Catalogue5

Newest first, rows 1-5 of 5

FDA recalls28

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 28 recalls initiated by Deltec, Inc., the earliest on 2003-03-14 and the most recent on 2004-03-29. By recorded status: 28 terminated. The reasons filed fall into these groups: software or firmware, sterility or contamination and packaging. 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 28 recalls.

  • 2004

    • 29 Mar 2004 Z-0856-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: P900052
    • 29 Mar 2004 Z-0857-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: P900052
    • 29 Mar 2004 Z-0858-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K954015
    • 29 Mar 2004 Z-0859-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K954015
    • 29 Mar 2004 Z-0860-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K954015
    • 29 Mar 2004 Z-0861-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide.
    • 29 Mar 2004 Z-0862-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide.
    • 29 Mar 2004 Z-0863-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K973862
    • 29 Mar 2004 Z-0864-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K973862
    • 29 Mar 2004 Z-0865-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K932840
Show the 25 most recent of 28 recalls

  • 2004

    • 29 Mar 2004 Z-0866-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K962695
    • 29 Mar 2004 Z-0867-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K962695
    • 29 Mar 2004 Z-0868-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K962695
    • 29 Mar 2004 Z-0869-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K962695
    • 29 Mar 2004 Z-0870-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K962695
    • 29 Mar 2004 Z-0871-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K994216
    • 29 Mar 2004 Z-0872-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K994216
    • 29 Mar 2004 Z-0873-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K994216
    • 29 Mar 2004 Z-0874-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K994216
    • 29 Mar 2004 Z-0875-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K994216
    • 29 Mar 2004 Z-0876-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K962695
    • 29 Mar 2004 Z-0877-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K974471
    • 29 Mar 2004 Z-0878-04 Unclassified (pre-2012) Terminated Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. Distribution: The recalled products were shipped nationwide in the United States and worldwide. Submission number: K974471

  • 2003

    • 8 Jul 2003 Z-1066-03 Unclassified (pre-2012) Terminated Silicone adhesive in kits used to repair damaged catheters did not set (cure) properly and remained in a tacky state. Distribution: The product was shipped to 14 consignees (hospitals) in California, Illinois, Kansas, Michigan, Minnesota, Missouri,…
      Full distribution text The product was shipped to 14 consignees (hospitals) in California, Illinois, Kansas, Michigan, Minnesota, Missouri, Pennsylvania, and Texas.
      Submission number: K904334
    • 8 Jul 2003 Z-1067-03 Unclassified (pre-2012) Terminated Silicone adhesive in kits used to repair damaged catheters did not set (cure) properly and remained in a tacky state. Distribution: The product was shipped to 14 consignees (hospitals) in California, Illinois, Kansas, Michigan, Minnesota, Missouri,…
      Full distribution text The product was shipped to 14 consignees (hospitals) in California, Illinois, Kansas, Michigan, Minnesota, Missouri, Pennsylvania, and Texas.
      Submission number: K904334

Frequently asked questions

How many devices does Deltec, Inc. have in the registry?

The registry currently lists 5 devices for Deltec, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Deltec, Inc.'s devices?

Among its 5 most recently registered devices, Deltec, Inc. has devices listed in FDA 510(k) (5 devices).

What risk classes do Deltec, Inc.'s devices fall under?

Among its 5 most recently registered devices, the classes recorded for Deltec, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Deltec, Inc.?

FDA recall records list 28 recalls initiated by Deltec, Inc., the most recent initiated on 2004-03-29. 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 Deltec, Inc. in the registry?

The most recently registered devices listed for Deltec, Inc. include CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP, GRIPPER PLUS NEEDLE, TRUFLOW DUAL-LUMEN POLYURETHANE LONG-TERM STRAIGHT DIALYSIS CATHETER (12.5 FR X 24 CM) WITH TRAY, TRUFLOW DUAL-LUMEN POY and DELTEC INSULIN INFUSION PUMP AND ACCESSORIES.

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