Browse Device Recalls
3,096 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,096 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 3,096 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 30, 2023 | Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION W... | The outer package seal could be open, or compromised which affects the sterility of the procedure... | Class II | DeRoyal Industries Inc |
| May 30, 2023 | Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219 | The outer package seal could be open, or compromised which affects the sterility of the procedure... | Class II | DeRoyal Industries Inc |
| May 30, 2023 | Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDAR... | The outer package seal could be open, or compromised which affects the sterility of the procedure... | Class II | DeRoyal Industries Inc |
| May 30, 2023 | Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF... | The outer package seal could be open, or compromised which affects the sterility of the procedure... | Class II | DeRoyal Industries Inc |
| May 30, 2023 | Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK,... | The outer package seal could be open, or compromised which affects the sterility of the procedure... | Class II | DeRoyal Industries Inc |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the fo... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 15, 2023 | Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound ... | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility spe... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.