Instrumed International, Inc.

Complete recall history across all FDA and CPSC categories — 38 total recalls

Instrumed International, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (38)

FDA medical device enforcement actions by Instrumed International, Inc.

Date Product Reason Class
Sep 8, 2014 Lock nuts for titanium traction tongs are used in traction skull tongs for tr... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 Hudson braces are bone cutting and drilling instruments that are used without... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 Replacement screw non-springloaded traction tongs are skull tongs for tractio... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 Traction tong replacement screws, non-springloaded are used in traction skull... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 Hudson cerebellar extensions are bone cutting and drilling instruments that a... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 Manual trephines are bone cutting and drilling instruments that are used with... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 Cushing burrs are bone cutting and drilling instruments that are used without... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 Tonometers are manual devices intended to measure intraocular pressure by app... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 An external vein stripper is an extravascular device used to remove a section... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 A trocar is a sharp-pointed instrument used with a cannula for piercing a ves... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 Hudson burrs are bone cutting and drilling instruments that are used without ... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 Galt trephines are bone cutting and drilling instruments that are used withou... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 Titanium fixation screws, springloaded are used in traction skull tongs for t... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 CVB distraction screws are bone cutting and drilling instruments that are use... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 Cushing perforating drills are bone cutting and drilling instruments that are... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 Cloward Spanner gauges are bone cutting and drilling instruments that are use... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 Gardner-Wells wrenches are used in traction skull tongs for traction used to ... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 Manual bunnell cranial drills are bone cutting and drilling instruments that ... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 McKenzie Perforator Drills are bone cutting and drilling instruments that are... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 An endometrial suction curette is a device used to remove material from the u... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 A circumcision clamp is an instrument used to compress the foreskin of the pe... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 Schoitz weights are manual devices used with Schoitz tonometers and are inten... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 A uterine tenaculum is a hook-like instrument used to seize and hold the cerv... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and d... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 Gardner-Wells traction tongs are skull tongs for traction used to immobilize ... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 McKenzie enlarging burrs are bone cutting and drilling instruments that are u... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 A zipser clamp is an instrument used to compress reduce blood flow to the pen... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
Sep 8, 2014 D'errico perforator drills are bone cutting and drilling instruments that are... The reason these devices are being withdrawn from the market by Instrumed is ... Class II
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for... Class II
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for... Class II
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for... Class II
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for... Class II
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for... Class II
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for... Class II
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for... Class II
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for... Class II
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for... Class II
May 30, 2014 Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and s... Additional caution statements have been added to the Instructions For Use for... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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