Browse Device Recalls
1,062 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 1,062 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 1,062 FDA device recalls in OH.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.