Browse Device Recalls
12 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 12 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 12 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 6, 2026 | PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With ... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability W... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With ... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without ... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability W... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Jan 6, 2026 | PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or... | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Co... | Class II | VANTIVE US HEALTHCARE LLC |
| Aug 28, 2025 | Sharesource Connectivity Platform for Use with Homechoice Claria Product C... | Vantive has identified a software defect within the Sharesource Claria software, which may cause ... | Class II | Vantive US Healthcare LLC |
| Jul 28, 2025 | PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 | Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or dif... | Class II | VANTIVE US HEALTHCARE LLC |
| Jul 28, 2025 | TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 9555... | Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit lea... | Class II | VANTIVE US HEALTHCARE LLC |
| Jul 28, 2025 | PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, ... | Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air De... | Class II | VANTIVE US HEALTHCARE LLC |
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.