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E-Z-Em, Inc.

United StatesFDA applicant, unverified FDA FEI 2411512

Devices
56
Registrations
FDA
FDA recalls
3

What E-Z-Em, Inc. makes

E-Z-Em, Inc. manufactures a range of single-use medical devices for procedural and diagnostic applications, including enteric drainage tubes with guide wires, biopsy needles for soft tissue and Lufkin core sampling, puncture/drainage systems, winged infusion sets, bronchial cytology brushes, angiography needles, cystoscopy aids, vascular fluid management systems, bloodless needle devices, automated injector systems, vacuum aspiration syringes, and various biopsy needle designs.

The company’s products are regulated under FDA classifications spanning Class I, Class II, Class III, and unclassified (U) devices, with many authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.

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

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Company details

FDA FEI number
2411512
Address
510 Carnegie Center, Princeton, NJ, 08540

FDA recalls3

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

FDA recall records list 3 recalls initiated by E-Z-Em, Inc., initiated on 2004-12-03. By recorded status: 3 terminated. The reasons filed fall into these groups: 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.

  • 2004

    • 3 Dec 2004 Z-0548-05 Unclassified (pre-2012) Terminated Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor. Distribution: Medical facilities, 1 distributor & 1 physician nationwide. There were also foreign accounts in Canada, United Kingdom,…
      Full distribution text Medical facilities, 1 distributor & 1 physician nationwide. There were also foreign accounts in Canada, United Kingdom, France, The Netherlands and Korea.
      Submission numbers: K031571, K011160
    • 3 Dec 2004 Z-0549-05 Unclassified (pre-2012) Terminated Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor. Distribution: Medical facilities, 1 distributor & 1 physician nationwide. There were also foreign accounts in Canada, United Kingdom,…
      Full distribution text Medical facilities, 1 distributor & 1 physician nationwide. There were also foreign accounts in Canada, United Kingdom, France, The Netherlands and Korea.
      Submission numbers: K031571, K011160
    • 3 Dec 2004 Z-0550-05 Unclassified (pre-2012) Terminated Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor. Distribution: Medical facilities, 1 distributor & 1 physician nationwide. There were also foreign accounts in Canada, United Kingdom,…
      Full distribution text Medical facilities, 1 distributor & 1 physician nationwide. There were also foreign accounts in Canada, United Kingdom, France, The Netherlands and Korea.
      Submission numbers: K031571, K011160