Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 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 12 FDA device recalls in 2006.

Date	Product	Reason	Class	Firm
Dec 12, 2006	PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile...	Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation whi...	Class II	Biomet, Inc.
Nov 20, 2006	OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during di...	Please be aware that this is not a new recall. The firm has taken action; but, due to administra...	Class I	GE OEC Medical Systems, Inc
Nov 20, 2006	OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system ...	Please be aware that this is not a new recall. The firm has taken action; but, due to administra...	Class I	GE OEC Medical Systems, Inc
Nov 20, 2006	OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic...	Recalled in November 2006 due to several intermittent potential safety issues including navigatio...	Class II	GE OEC Medical Systems, Inc
Nov 8, 2006	The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is...	GE Healthcare is aware of a few instances where the Axcess Cranial Screw has broken during insert...	Class II	GE OEC Medical Systems, Inc
Oct 11, 2006	OEC InstaTrak 3500, picture archiving and communications system intended as a...	GE Healthcare had recalled certain OEC InstaTrak 3500 Carts due to the potential for the cart to ...	Class II	GE OEC Medical Systems, Inc
Sep 15, 2006	InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing...	Please be aware that this is not a new recall. The firm has taken action; but, due to administra...	Class I	GE OEC Medical Systems, Inc
Jun 6, 2006	Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The ...	The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 in...	Class III	Radiometer America Inc
May 31, 2006	GE Proteus XR/a Radiographic System. GE Medical Systems-Americas Milwaukee, ...	An incident was reported that an operator's finger was pinched between the fixed roller and the g...	Class II	General Electric Med Systems LLC
May 31, 2006	GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3...	An incident was reported that an operator's finger was pinched between the fixed roller and the g...	Class II	General Electric Med Systems LLC
May 31, 2006	GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha...	An incident was reported that an operator's finger was pinched between the fixed roller and the g...	Class II	General Electric Med Systems LLC
Apr 25, 2006	Brilliance CT (computed tomography) scanners, Big Bore configuration, Model n...	Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization appli...	Class II	Philips Medical Systems (Cleveland) 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.