Reshape Medical recalls
Reshape Medical has 2 recalls on record with the FDA and USDA, the earliest in 2016 and the latest reported on 16 Nov 2016. The most frequent reason is packaging defects.
Total recalls2since 2016
Last 12 months0reported
Class I00% of total
Ongoing0latest 16 Nov 2016
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 reshape medical is recalled
Product types
By year
All reshape medical recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ReShape Integrated Dual Balloon System, Gen recalled by Reshape Medical | Reshape Medical | Packaging Defects | Nationwide |
| Device | CLASS II | ReShape Integrated Dual Balloon System, Gen recalled by Reshape Medical | Reshape Medical | Lead & Heavy Metals | CA, NY, OH |
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.