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Instrumed International, Inc.

Country not established

Devices
7
FDA recalls
38

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Instrumed International, Inc. makes

Instrumed International, Inc. manufactures surgical instruments including rongeurs, obstetrical/gynecological forceps, vascular clamps, laparoscopes and accessories, retractors, and vessel dilators.

The company's devices are all classified as Class II and listed in the FDA 510(k) registry. Instrumed International is based in the US.

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

Catalogue7

Newest first, rows 1-7 of 7

FDA recalls38

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

FDA recall records list 38 recalls initiated by Instrumed International, Inc., the earliest on 2014-05-30 and the most recent on 2014-09-08. By recorded status: 38 terminated. The reasons filed fall into these groups: labeling or instructions for use. 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 38 recalls.

  • 2014

    • 8 Sep 2014 Z-0532-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0533-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0534-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0535-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0536-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0537-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0538-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0539-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0540-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0541-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
Show the 25 most recent of 38 recalls

  • 2014

    • 8 Sep 2014 Z-0542-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0543-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0544-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0545-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0546-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0547-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0548-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0549-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0550-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0551-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0552-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0553-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0554-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0555-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
    • 8 Sep 2014 Z-0556-2015 Class II Terminated The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. Distribution: Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.

Frequently asked questions

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

The registry currently lists 7 devices for Instrumed International, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Instrumed International, Inc.'s devices?

Among its 7 most recently registered devices, Instrumed International, Inc. has devices listed in FDA 510(k) (7 devices).

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

Among its 7 most recently registered devices, the classes recorded for Instrumed International, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Instrumed International, Inc.?

FDA recall records list 38 recalls initiated by Instrumed International, Inc., the most recent initiated on 8 Sep 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 Instrumed International, Inc. in the registry?

The most recently registered devices listed for Instrumed International, Inc. include INSTRUMED RONGEUR, INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL, INSTRUMED VASCULAR CLAMPS and INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX.

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