Browse Device Recalls
39,969 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,969 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 39,969 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 22, 2023 | Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only | There is a potential that valve assemblies will not open. preventing fluid from draining. | Class II | Merit Medical Systems, Inc. |
| Apr 22, 2023 | Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx ... | There is a potential that valve assemblies will not open. preventing fluid from draining. | Class II | Merit Medical Systems, Inc. |
| Apr 22, 2023 | Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version... | There is a potential that valve assemblies will not open. preventing fluid from draining. | Class II | Merit Medical Systems, Inc. |
| Apr 22, 2023 | Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version... | There is a potential that valve assemblies will not open. preventing fluid from draining. | Class II | Merit Medical Systems, Inc. |
| Apr 22, 2023 | Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A... | There is a potential that valve assemblies will not open. preventing fluid from draining. | Class II | Merit Medical Systems, Inc. |
| Apr 22, 2023 | Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A... | There is a potential that valve assemblies will not open. preventing fluid from draining. | Class II | Merit Medical Systems, Inc. |
| Apr 22, 2023 | Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version... | There is a potential that valve assemblies will not open. preventing fluid from draining. | Class II | Merit Medical Systems, Inc. |
| Apr 22, 2023 | Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx ... | There is a potential that valve assemblies will not open. preventing fluid from draining. | Class II | Merit Medical Systems, Inc. |
| Apr 22, 2023 | Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A... | There is a potential that valve assemblies will not open. preventing fluid from draining. | Class II | Merit Medical Systems, Inc. |
| Apr 22, 2023 | Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx On... | There is a potential that valve assemblies will not open. preventing fluid from draining. | Class II | Merit Medical Systems, Inc. |
| Apr 22, 2023 | Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx On... | There is a potential that valve assemblies will not open. preventing fluid from draining. | Class II | Merit Medical Systems, Inc. |
| Apr 22, 2023 | Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version ... | There is a potential that valve assemblies will not open. preventing fluid from draining. | Class II | Merit Medical Systems, Inc. |
| Apr 21, 2023 | Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 | TC-I tip clip sensor may produce readings outside the accuracy specification. | Class II | Masimo Corporation |
| Apr 21, 2023 | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 | TC-I tip clip sensor may produce readings outside the accuracy specification. | Class II | Masimo Corporation |
| Apr 21, 2023 | Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 | TC-I tip clip sensor may produce readings outside the accuracy specification. | Class II | Masimo Corporation |
| Apr 21, 2023 | Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 | TC-I tip clip sensor may produce readings outside the accuracy specification. | Class II | Masimo Corporation |
| Apr 21, 2023 | Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (... | The kits were damaged by water. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Apr 20, 2023 | Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G... | Some catheters had a manufacturing defect where the clear resealing label separating from the pro... | Class II | C.R. Bard Inc |
| Apr 20, 2023 | Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 5... | Some catheters had a manufacturing defect where the clear resealing label separating from the pro... | Class II | C.R. Bard Inc |
| Apr 20, 2023 | Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 5180... | Some catheters had a manufacturing defect where the clear resealing label separating from the pro... | Class II | C.R. Bard Inc |
| Apr 20, 2023 | HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b... | Some catheters had a manufacturing defect where the clear resealing label separating from the pro... | Class II | C.R. Bard Inc |
| Apr 19, 2023 | Patient Information Center iX, Product Code 866386, and Patient Information C... | During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Proto... | Class II | Philips North America |
| Apr 18, 2023 | Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA II... | The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the end... | Class II | Olympus Corporation of the Americas |
| Apr 17, 2023 | ID Coax 180, MP03375 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | VentStar Coax (P) 150, MP00379 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | VentStar Watertrap (P) 180 w/oLL, MP00362 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | Total Knee Pack, REF CETJ130, medical convenience kits | Incorrect expiration date on product. | Class III | American Contract Systems, Inc. |
| Apr 17, 2023 | VentStar Bag Set (N) 110, MP00383 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | Ventstar Coax 230, MP03376 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | Anesthesia Circuit Kit Coax HEPA, MP17102 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | VentStar breathing bag Set (P) 110, MP00384 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | VentStar Basic (N) 180, MP00353 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK,... | The custom procedure packs contain light handle covers that have been recalled by another firm. | Class II | DeRoyal Industries Inc |
| Apr 17, 2023 | Anesthesia Circuit Kit Coax 1, MP02730 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | Ventstar Coax 180, MP03374 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | Anesthesia Circuit Kit Coax 3, MP02732 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | VentStar Basic (P)250, MP00352 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | ID Circuit Basic (P) 180, MP01340 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | Ventstar Coax, MP03373 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | VentStar Anesthesia (N) 180, MP00333 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | VentStar Watertrap (P) 180, MP00361 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | VentStar Watertrap (N) 180, MP00363 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determi... | Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis | Class II | Ortho-Clinical Diagnostics, Inc. |
| Apr 17, 2023 | Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood p... | The Impella 5.5 pump experienced a heightened complaint rate for purge leaks. | Class I | Abiomed, Inc. |
| Apr 17, 2023 | Anesthesia Set Coax 180, MP03384 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTIO... | The custom procedure packs contain light handle covers that have been recalled by another firm. | Class II | DeRoyal Industries Inc |
| Apr 17, 2023 | VentStar Anesthesia WT (P)180, MP00374 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | Seattle PAP Plus, MP02260 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | Set2Go Ventilation 12 (A), MP07968 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, Inc. |
| Apr 17, 2023 | VentStar Basic (P)180, MP00351 | Glued connections of the breathing circuit can become loose before or during ventilation resultin... | Class I | Draeger Medical, 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.