Unimed Surgical Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 13
- FDA recalls
- 13
At a glance
Market reach
- United States
- FDA recalls
What Unimed Surgical Products, Inc. makes
Unimed Surgical Products, Inc. manufactures electrosurgical electrodes and forceps, including bipolar forceps for endoscopic procedures, coated needle, blade, and ball electrodes for precision cutting and coagulation, and disposable hand/foot-switching pencils with holsters and blade cleaners. Their portfolio also includes suction-irrigation electrodes for arthroscopy and laparoscopy, as well as specialized electrodes for procedures like LLETZ treatments, including loop and square loop designs. The company produces both reusable and disposable electrosurgical tools for surgical applications.
The company’s devices are classified as Class II under FDA regulations and are listed in the 510(k) clearance registry. Their products are intended for use in the United States, where they comply with applicable medical device standards and requirements.
Catalogue
Search and filter all 13 devicesFDA recalls
FDA recall records list 13 recalls initiated by Unimed Surgical Products, Inc., the earliest on 2009-08-28 and the most recent on 2013-02-15. By recorded status: 13 terminated. The reasons filed fall into these groups: sterility or contamination 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.
2013
- 15 Feb 2013 Z-1347-2013 Class II Terminated Firm is recalling due to concerns regarding changes that were made to the PTFE coating materials.
2010
- 16 Jun 2010 Z-2286-2012 Class II Terminated On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
- 16 Jun 2010 Z-2287-2012 Class II Terminated On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
- 16 Jun 2010 Z-2288-2012 Class II Terminated On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
- 16 Jun 2010 Z-2289-2012 Class II Terminated On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
- 16 Jun 2010 Z-2290-2012 Class II Terminated On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
- 16 Jun 2010 Z-2291-2012 Class II Terminated On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
- 16 Jun 2010 Z-2292-2012 Class II Terminated On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
- 16 Jun 2010 Z-2293-2012 Class II Terminated On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
- 16 Jun 2010 Z-2294-2012 Class II Terminated On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
Show all 13 recalls
2010
- 16 Jun 2010 Z-2295-2012 Class II Terminated On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
- 16 Jun 2010 Z-2296-2012 Class II Terminated On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
2009
- 28 Aug 2009 Z-0069-2010 Unclassified (pre-2012) Terminated Unimed Surgical Products, Inc., Largo, FL initiated a voluntary recall of the Extended PTFE Coated Blade electrosurgical electrodes, product number ES0014, due to concerns regarding product sterility for Lot #042209-03.
Frequently asked questions
How many devices does Unimed Surgical Products, Inc. have in the registry?
The registry currently lists 13 devices for Unimed Surgical Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Unimed Surgical Products, Inc.'s devices?
Among its 13 most recently registered devices, Unimed Surgical Products, Inc. has devices listed in FDA 510(k) (13 devices).
What risk classes do Unimed Surgical Products, Inc.'s devices fall under?
Among its 13 most recently registered devices, the classes recorded for Unimed Surgical Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Unimed Surgical Products, Inc.?
FDA recall records list 13 recalls initiated by Unimed Surgical Products, Inc., the most recent initiated on 15 Feb 2013. 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 Unimed Surgical Products, Inc. in the registry?
The most recently registered devices listed for Unimed Surgical Products, Inc. include SURGI-LINK ENDOSCOPIC BIPOLAR FORCEPS, UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE, UNIMED DISPOSABLE HAND AND FOOT-SWITCHING PENCILS WITH HOLSTER AND 1BLADE AND TIP CLEANER, UNIMED DISPOSABLE HAND AND F and NEEDLE ELCTRODE.