Browse Device Recalls
3,505 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,505 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 3,505 FDA device recalls in MA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 3, 2015 | Allura Xper FD20/20; Model Number: 722038 Dedicated vascular and neurovas... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | Allura Xper FD20/15; Model Numbers: 722058 Dedicated vascular and neurovas... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | Allura Xper FD20 OR Table; Model Numbers: 722035 722023 Dedicated vascular... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | INTEGRIS BV3000 MONO; Model Number: 72241 The Philips INTEGRIS 3000 I 5000... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications. | Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the el... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | INTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS 3000 I 5000 syste... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | INTEGRIS HM3000; Model Number: 72239 The Philips INTEGRIS 3000 I 5000 syst... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | Allura Xper FD20; Model Numbers: 722028 722012 722006 Dedicated vascular a... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | Cardiovascular Allura Centron; Model Number: 722400 The Allura CV2O is in... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated ... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | INTEGRIS Allura 9 (biplane); Model Number: 722021 The Philips INTEGRIS 300... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on hum... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications. | Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the el... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 s... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 syste... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | INTEGRIS Allura 15-12 (mono); Model Number: 722043 The Philips INTEGRIS 30... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicia... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 syst... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | INTEGRIS BH5000; Model Number: 72247 The Philips INTEGRIS 3000 I 5000 syst... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | INTEGRIS BH3000; Model Number: 72242 The Philips INTEGRIS 3000 I 5000 syst... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | Allura Xper FD20 Biplane; Model Numbers: 722013 722008 722015 Dedicated va... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | INTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 syste... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardi... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | INTEGRIS Allura 15-12 (biplane); Product Code: 722044 The Philips INTEGRIS... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | Allura Xper FD20/20 OR Table; Model Number: 722039 Dedicated vascular an... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | Allura Xper FD20/10; Model Numbers: 722029 Dedicated vascular and neurovas... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system ... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Card... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | INTEGRIS V3000; Model Number: 72243, 72244, 72245 The Philips INTEGRIS 300... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 3, 2015 | Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 72... | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live... | Class II | Philips Electronics North America Corporation |
| Nov 2, 2015 | OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Produc... | Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechan... | Class I | Insulet Corporation |
| Nov 2, 2015 | OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product ... | Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechan... | Class I | Insulet Corporation |
| Oct 29, 2015 | NxStage System One S Cycler (High Permeability Hemodialysis System) Model no... | Ultrafiltration (UF) Volume software error inaccurate fluid removal | Class II | NxStage Medical, Inc. |
| Oct 29, 2015 | NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis. | Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may c... | Class II | NxStage Medical, Inc. |
| Oct 29, 2015 | NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodia... | Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may c... | Class II | NxStage Medical, Inc. |
| Oct 29, 2015 | NxStage System One S Cycler -High Permeability Hemodialysis System Model no... | Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may co... | Class II | NxStage Medical, Inc. |
| Oct 29, 2015 | NxStage System One S Cycler (High Permeability Hemodialysis System) Model no... | Ultrafiltration (UF) Volume software error inaccurate fluid removal | Class II | NxStage Medical, Inc. |
| Oct 23, 2015 | Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use i... | Dissolution units and replacement motors units do not provide full thermal protection for both th... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Oct 23, 2015 | Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075... | Dissolution units and replacement motors units do not provide full thermal protection for both th... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Oct 23, 2015 | Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147. For Use in the... | Dissolution units and replacement motors units do not provide full thermal protection for both th... | Class II | Fresenius Medical Care Renal Therapies Group, LLC |
| Oct 21, 2015 | LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651... | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... | Class II | LeMaitre Vascular, Inc. |
| Oct 21, 2015 | LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654... | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... | Class II | LeMaitre Vascular, Inc. |
| Oct 21, 2015 | LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601... | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... | Class II | LeMaitre Vascular, Inc. |
| Oct 21, 2015 | LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. ... | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... | Class II | LeMaitre Vascular, Inc. |
| Oct 21, 2015 | LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. In... | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... | Class II | LeMaitre Vascular, Inc. |
| Oct 21, 2015 | LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and ... | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... | Class II | LeMaitre Vascular, Inc. |
| Oct 21, 2015 | LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model ... | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... | Class II | LeMaitre Vascular, Inc. |
| Oct 21, 2015 | LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601... | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... | Class II | LeMaitre Vascular, Inc. |
| Oct 21, 2015 | LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654... | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... | Class II | LeMaitre Vascular, Inc. |
| Oct 21, 2015 | LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601... | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead... | Class II | LeMaitre Vascular, 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.