Browse Device Recalls

1,067 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,067 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 1,067 FDA device recalls in OH.

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DateProductReasonClassFirm
Feb 8, 2012 The finger cots are made out of natural rubber. They are disposable products... The firm is initiating a field correction because the product(s) were missing the Latex Warning L... Class II Afassco Inc
Dec 22, 2011 Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc... US Endoscopy received five complaints which noted difficulty in deploying the cytology brush thro... Class II US Endoscopy Group Inc
Nov 14, 2011 Endoscopic retrieval device. The disposable Raptor grasping device in inte... When the outer catheter is either coiled or in a contorted configuration outside of the endoscope... Class II US Endoscopy Group Inc
Sep 1, 2011 The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems inte... During a Field Test (a customer external evaluation period), the customer detected a problem in t... Class II Philips Medical Systems (Cleveland) Inc
Mar 7, 2011 Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, ... The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a re... Class II Philips Medical Systems (Cleveland) Inc
Mar 3, 2011 Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running ... Multiple software defects which could impact the performance or reliability of the system. These... Class II Philips Medical Systems (Cleveland) Inc
Feb 2, 2011 AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus M... The "Retaining washers & Clevis Pins" provided with the AC -powered adjustable hospital beds may ... Class II Primus Medical LLC
Aug 18, 2010 G7 HPLC. Used as an aid in the detection and presumptive identification of... The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performan... Class III Tosoh Bioscience Inc
Feb 17, 2010 A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible gener... Customers may be storing objects on the base and/or around the column of the surgical table. Thi... Class II Steris Corporation
Feb 1, 2010 The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approxi... A report was received from a Japanese distributor regarding a complaint from a hospital customer ... Class II Mallinckrodt Inc
Jan 29, 2010 OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465... The tips of the drivers are breaking while being used to drive the screws into patients. Class II Orthohelix Surgical Designs Inc
Jan 29, 2010 OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465... The tips of the drivers are breaking while being used to drive the screws into patients. Class II Orthohelix Surgical Designs Inc
May 1, 2008 GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile install... The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT s... Class II Philips Medical Systems (Cleveland) Inc
Jan 9, 2007 No packaging. The device is a computed tomography scanner. Intended to ... When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in te... Class II Philips Medical Systems (Cleveland) 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
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
Dec 27, 2005 Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as sin... The system has a gap that can appear between the upper and lower tilt stand covers. The fingers m... 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.