Browse Device Recalls
3,367 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,367 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 3,367 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 5, 2012 | Plum A+ Infusion Pump; List Number: 12391; Product Usage: The Plum A... | Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... | Class II | Hospira Inc. |
| Feb 5, 2012 | Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part:... | Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... | Class II | Hospira Inc. |
| Feb 5, 2012 | Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: Th... | Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... | Class II | Hospira Inc. |
| Feb 5, 2012 | Plum A+ Infusion Pump; List Number: 11973; Product Usage: The Plum A... | Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... | Class II | Hospira Inc. |
| Feb 5, 2012 | Plum A+ Infusion Pump; List Number: 12618; Product Usage: The Plum A... | Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... | Class II | Hospira Inc. |
| Feb 5, 2012 | *** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PL... | Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... | Class II | Hospira Inc. |
| Jan 31, 2012 | Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up t... | In the Abbott Molecular Bar Code Scanner User's Guide, List Number 6L88-02/09, the section Modify... | Class II | Abbott Molecular |
| Mar 16, 2011 | Symbiq One Channel Infuser; an Rx medical device infusion pump used to admini... | May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic sc... | Class II | Hospira Inc. |
| Mar 16, 2011 | Symbiq Two Channel Infuser; an Rx medical device infusion pump used to admini... | May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic sc... | Class II | Hospira Inc. |
| Mar 4, 2011 | Imagecast PACS is an image management system intended to be used by trained p... | In Imagecast PACS versions prior to 3.6.51.01, the estimated magnification factor (0018,1114) was... | Class II | Ge Healthcare It |
| Mar 4, 2011 | Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syr... | Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (... | Class III | Baxter Healthcare Corp. |
| Mar 4, 2011 | Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated s... | Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (... | Class III | Baxter Healthcare Corp. |
| 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 |
| Jul 31, 2009 | Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposabl... | There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of th... | Class II | Baxter Healthcare Corp. |
| Jul 31, 2009 | Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposabl... | There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of th... | Class II | Baxter Healthcare Corp. |
| Jul 31, 2009 | Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposabl... | There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of th... | Class II | Baxter Healthcare Corp. |
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.