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Browse Device Recalls

38 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 38 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 38 FDA device recalls.

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DateProductReasonClassFirm
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 The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
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 The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
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 The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
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 The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
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 The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
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 The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
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 The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
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 The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 that Instrumed did n... Class II Instrumed International, Inc.
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 monopolar electrode... Class II Instrumed International, Inc.
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 monopolar electrode... Class II Instrumed International, Inc.
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 monopolar electrode... Class II Instrumed International, Inc.
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 monopolar electrode... Class II Instrumed International, Inc.
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 monopolar electrode... Class II Instrumed International, Inc.
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 monopolar electrode... Class II Instrumed International, Inc.
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 monopolar electrode... Class II Instrumed International, Inc.
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 monopolar electrode... Class II Instrumed International, Inc.
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 monopolar electrode... Class II Instrumed International, Inc.
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 monopolar electrode... Class II Instrumed International, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.