Browse Device Recalls
5 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5 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 5 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 26, 2024 | Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model... | Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slo... | Class II | Nova Ortho-Med Inc |
| Aug 26, 2024 | Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/C... | Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slo... | Class II | Nova Ortho-Med Inc |
| Aug 26, 2024 | Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Ca... | Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slo... | Class II | Nova Ortho-Med Inc |
| Oct 7, 2019 | Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue... | Walkers within the identified serial range have the potential for the front fork to unscrew itsel... | Class II | Nova Ortho-Med Inc |
| Oct 1, 2016 | 4205 Journey Rolling Walker Product Usage: used to assist people in walking | Nova Medical is recalling the Journey Rolling Walker because the screws used to hold the black si... | Class II | Nova Ortho-Med 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.