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 |
|---|---|---|---|---|
| Feb 24, 2016 | Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 ca... | Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolp... | Class I | Biomerieux Inc |
| Feb 11, 2016 | USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Di... | Product may kink during use rendering the product unusable. | Class II | Us Endovascular |
| Dec 23, 2015 | Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Ca... | One complaint of a seat on a scale failing unexpectedly which can cause an injury. | Class II | Cardinal Scale Mfg Co |
| Dec 1, 2015 | CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively... | Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood... | Class II | Partners In Medicine Llc |
| Nov 23, 2015 | Granada Biphasic Broth The product is a selective medium for the screening... | FDA has determined that the product requires 510(k) clearance to continue marketing/distribution ... | Class II | Biomerieux Inc |
| Oct 28, 2015 | DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to mea... | Device is not functioning as intended: Two wires running to the ECG distribution circuit board a... | Class III | BC Group International Inc |
| Sep 8, 2015 | Prism Medical C-300 Consumer Ceiling Lift; PN 330050, 330050R, 330053, 330053... | Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling... | Class II | ErgoSafe Products, LLC (DBA) Prism Medical |
| Sep 8, 2015 | Prism Medical P-300 Portable Consumer Lift; PN 303050, 303050R, and 303051; w... | Drive shaft and over speed arm may simultaneously fail potentially resulting in a patient falling... | Class II | ErgoSafe Products, LLC (DBA) Prism Medical |
| Aug 25, 2015 | Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical ki... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical ki... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom pro... | The kits contain pressure monitoring kits or sets which are being recalled as a result of flow re... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical k... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical ki... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for car... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular s... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 25, 2015 | Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical ki... | Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled d... | Class II | Resource Optimization & Innovation Llc |
| Aug 19, 2015 | Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. U... | Surgical kits contain a surgical scrub product which may be chemically contaminated and lack ster... | Class II | Resource Optimization & Innovation Llc |
| Aug 19, 2015 | Regard Custom Surgical Pack, Item Number: 800208002; Sterile, CV0361B - CABG ... | Surgical kits contain a surgical scrub product which may be chemically contaminated and lack ster... | Class II | Resource Optimization & Innovation Llc |
| Jun 24, 2015 | Prism Medical P-600 Portable Ceiling Lift; PN 303090. Patient lift with weigh... | There is a potential the sling loops may not stay attached to the carry bar hooks. | Class II | ErgoSafe Products, LLC (DBA) Prism Medical |
| Jun 24, 2015 | Prism Medical P-440 Portable Ceiling Lift; PN 303070 and 303070R (refurbished... | There is a potential the sling loops may not stay attached to the carry bar hooks. | Class II | ErgoSafe Products, LLC (DBA) Prism Medical |
| Apr 22, 2015 | regard Item Number: 800414, Sterile, OR0483 - Total Joint Pk - surgical kit ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800569, Sterile, CV0659 - Open Heart A & B - surgical kit... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800599, Sterile, GS0694 - Robotic Lap - surgical kit cont... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800413, Sterile, CV0482 - Vascular Pk - surgical kit con... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number 800567001, Sterile, GY0656A - Robotic Hysterectomy - surg... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn surgical ki... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800567, Sterile, GY0656 - Robotic Hysterectomy - surgical... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800525, Sterile, OR0609 - Extremity Pack - surgical kit c... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800422001, Sterile, OR0491A - Arthroscopy Pk - surgical k... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800528, Sterile, GS0612 - Lap Chole Pk - surgical kit co... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800546, Sterile, GS0635 - Abdominal - surgical kit contai... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800560001, Sterile, GS0649A - Lap Chole - surgical kit co... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800036003, Sterile, LD0274C - C Section Pack - surgical k... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800524, Sterile, LD0608 - C Section - surgical kit conta... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800508, Sterile, LD0586 - C Section - surgical kit conta... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800417, Sterile, GY0486 - Laparoscopy Pk - surgical kit ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800419, Sterile, GY0488 - D&C Pk - surgical kit containi... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit contai... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800548, Sterile, OR0637 - Extremity - surgical kit contai... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit con... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800526, Sterile, ET0610 - Head and Neck - surgical kit co... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800559, Sterile, ET0648 - Head & Neck - surgical kit cont... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800555, Sterile, HT0644 - Pediatric Card Cath - surgical ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800557, Sterile, LD0646 - C-Section - surgical kit contai... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800527, Sterile, OR0611 - Hip Shoulder Pk - surgical kit ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 880331, Sterile, OR0762 - Total Knee - surgical kit cont... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800418, Sterile, GY0487 - Major Vaginal Pk - surgical ki... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 880321, Sterile, GS0752 - Breast Pk - surgical kit cont... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | 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.