Dynarex Corp.
United StatesFDA applicant, unverified FDA FEI 2431014
- Devices
- 2,705
- Registrations
- FDA
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Dynarex Corp. makes
Dynarex Corp. manufactures single-use medical devices including hypodermic needles, adhesive bandages, endotracheal tubes, and indwelling urethral drainage catheters. Their portfolio also covers respiratory products like heat/moisture exchangers and suction/irrigation tubing, as well as insulin syringes with safety features, intravenous administration sets, and protective barriers such as emesis bags and oral airways.
The company’s devices are classified under FDA’s Class I, Class II, and Unclassified (U) categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
Catalogue
Search and filter all 2,705 devicesShowing 1-50 of 2,705
Company details
- FDA FEI number
- 2431014
- Address
- 11 Dynarex Drive, Middletown, NY, 10941
FDA recalls
FDA recall records list 6 recalls initiated by Dynarex Corp., the earliest on 2002-12-31 and the most recent on 2018-05-08. By recorded status: 6 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 8 May 2018 Z-1955-2018 Class II Terminated The device is equipped with a dial that has an inaccurate flow rate indicator.
2016
- 3 Mar 2016 Z-2057-2016 Class II Terminated Exterior carton is mis-labeled as Sterile. Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
2014
- 2 Jul 2014 Z-2117-2014 Class II Terminated "THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.
2004
- 10 May 2004 Z-0951-04 Unclassified (pre-2012) Terminated Bandages labeled as "100% Latex Free" may contain latex. The wrapper was analytically tested by a private laboratory and found to contain latex.
Full distribution text
- 10 May 2004 Z-0951-04 Unclassified (pre-2012) Terminated Bandages labeled as "100% Latex Free" may contain latex. The wrapper was analytically tested by a private laboratory and found to contain latex.
2002
- 31 Dec 2002 Z-0572-03 Unclassified (pre-2012) Terminated Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.
- 31 Dec 2002 Z-0573-03 Unclassified (pre-2012) Terminated Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.
Frequently asked questions
How many devices does Dynarex Corp. have in the registry?
The registry currently lists 2705 devices for Dynarex Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dynarex Corp.'s devices?
Among its 50 most recently registered devices, Dynarex Corp. has devices listed in FDA GUDID (50 devices).
What risk classes do Dynarex Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Dynarex Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Dynarex Corp.?
FDA recall records list 6 recalls initiated by Dynarex Corp., the most recent initiated on 8 May 2018. 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 Dynarex Corp. in the registry?
The most recently registered devices listed for Dynarex Corp. include Resp-O2 M24 Oxygen E-Cylinder, With CGA 870 Post Valve, 4.55 L 36390-PBULK, Resp-O2 Oxygen Cylinder Wrenches, Black 36600, Resp-O2 Oxygen Cylinder Cart, Single 36620 and Resp-O2 Oxygen Cylinder Cart, Dual 36621.