Browse Device Recalls
65 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 65 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 65 FDA device recalls in 2010.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 16, 2010 | Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" ... | On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca... | Class II | Unimed Surgical Products, Inc. |
| May 20, 2010 | HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, ... | CGMP Deviations: Incomplete documentation associated with test results. | Class II | App Pharmaceuticals Llc |
| May 20, 2010 | HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, ... | CGMP Deviations: Incomplete documentation associated with test results. | Class II | App Pharmaceuticals Llc |
| May 14, 2010 | Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended ... | An issue with the plunger rod seal was identified where the seal had the potential to migrate ins... | Class II | Smiths Medical ASD, Inc. |
| Apr 28, 2010 | AperFix Femoral Implant Coring Removal Drill, labeled as the following: ... | A review of product complaints in 2010 identified a trend for the Coring Removal Drill of prematu... | Class II | Cayenne Medical Inc. |
| Apr 26, 2010 | GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB wi... | GE OEC recalled certain 9800 Fluoroscope & 9900 Elite Models because the Snubber Board did not co... | Class II | GE OEC Medical Systems, Inc |
| Apr 5, 2010 | Philips Healthcare Computed Tomography X-Ray System. These devices are who... | Philips Healthcare discovered the customer was performing CTDI measurements for facility accredi... | Class II | Philips Healthcare Inc. |
| Mar 11, 2010 | The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical ... | Customer complaint was received relating to a LifePak15 device that would power on then power dow... | Class II | Physio-Control, 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 |
| Jan 21, 2010 | Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointe... | These camera systems were manufactured by LMGS and found to fail to comply with the FDA laser pe... | Class II | Lockheed Martin Gyrocam Systems, Inc. |
| Jan 15, 2010 | Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.01... | Medacta USA is recalling Versafitcup Impacting Ring because the impaction ring may not fit proper... | Class II | Medacta Usa Inc |
| Jan 6, 2010 | ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.3... | The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80... | Class II | Sendx Medical 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.