Browse Device Recalls
929 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 929 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 929 FDA device recalls in MO.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 9, 2017 | Regard, Item Number: 800546001 Sterile, GS0635A - Abdominal - Medical Center ... | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800554003, Sterile, GS0643C - Pediatric Basic - Children... | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800418003, Sterile, GY0487C - Major Vaginal Pk - Spohn | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 880321002, Sterile, GS0752B - Breast PK - OSU | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800551001, Sterile, GS0640A - Lap Chole - Medical Center... | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800414001, Sterile, OR0483A - Total Joint PK - Spohn | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St F... | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800533002 Sterile, GS0606B - Abdominal PK - Westover Hills | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 880327005, Sterile, CV0758E - Open Heart A&B - OSU | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800566002, Sterile, NU0655B - VP Shunt - Childrens Sant... | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 880321003, Sterile, GS0752C - Breast PK - OSU | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800568002, Sterile, OR0658 - Titanium Rib - Childrens Sa... | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 880323003, Sterile, LD0754C - C Section - OSU | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800527002 Sterile, OR0611B - Hip Shoulder PK - Westover ... | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800416002, Sterile, GY0485B - Robotic Hysterectomy Pk - ... | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800408003, Sterile, LD0477C - C-Section PK - Spohn | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 880342004, Sterile, GS0776D - Laparotomy - OSU | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800419001, Sterile, GY0488A - D&C Pk - Spohn | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 880321001, Sterile, GS0752A - Breast Pk - OSU | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800408002, Sterile, LD0477B - C-Section PK - Spohn | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800569002, Sterile, CV0659B - Open Heart A&B - Medical C... | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800567002, Sterile, GY0656B- Robotic Hysterectomy - Alamo | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800533003 Sterile, GS0606C - Abdominal PK - Westover Hills | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800555001, Sterile, HT0644A - Pediatric Card Cath - Chil... | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800535002 Sterile, LD0620B - C Section - New Braunfels | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800568005, Sterile, OR0658E - Titanium Rib - Childrens S... | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800623002, Sterile, NU0787B - Neuro - Medical Center Sa... | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 880342003, Sterile, GS0776C - Laparotomy - OSU | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800559001, Sterile, ET0648A - Head & Neck - Childrens Sa... | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 880331001, Sterile, OR0762A - Total Knee - OSU | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800407002, Sterile, OR0476B - Ortho PK - Spohn | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 880341003, Sterile, GS0775C - Laparoscopic - OSU | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 880323002, Sterile, LD0754B - C Section - OSU | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 880342002, Sterile, GS0776B - Laparotomy - OSU | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800425001, Sterile, CV0494A - AV Access Pk - Spohn | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800524004, Sterile, LD0608D - C Section - Westover Hills | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800527004 Sterile, OR0611D - Hip Shoulder PK - Westover ... | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800508002, Sterile, LD0586B - C Section - Jasper | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800549002, Sterile, ET0638B - Head & Neck - Medical Cent... | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800418001, Sterile, GY0487A - Major Vaginal PK - Spohn | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800425002, Sterile, CV0494B - AV Access Pk - Spohn | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800409002, Sterile, GS0478B - Lap Chole PK - Spohn | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800525002 Sterile, OR0609B - Extremity Pack - Westover H... | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800569003, Sterile, CV0659C - Open Heart A&B - Medical C... | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 880330003, Sterile, OR0761C - Total Hip - OSU | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 880327007, Sterile, CV0758G - Open Heart A&B - OSU | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800410005, Sterile, CV0479E- Open Heart PK - Spohn | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 800508001, Sterile, LD0586A - C Section - Jasper | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation Llc |
| Jan 9, 2017 | Regard, Item Number: 880330005, Sterile, OR0761E - Total Hip - OSU | Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... | Class II | Resource Optimization & Innovation 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.