Shape Medical Systems recalls
Shape Medical Systems has 2 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 11 Feb 2015.
Total recalls2since 2014
Last 12 months0reported
Class I00% of total
Ongoing0latest 11 Feb 2015
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 2 100%Class III 0 0%
Why shape medical systems is recalled
Product types
By year
All shape medical systems recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Shape-HF Cardiopulmonary Testing System Disposable Patient recalled | Shape Medical Systems | Other | 10 states |
| Device | CLASS II | Shape HF Cardiopulmonary System recalled by Shape Medical Systems | Shape Medical Systems | Device Malfunction | Nationwide |
About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.