Browse Device Recalls

3,419 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,419 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 3,419 FDA device recalls in MA.

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DateProductReasonClassFirm
Nov 11, 2015 Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be use... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measuremen... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be use... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitativ... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in ... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be u... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 10, 2015 MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The Med... A small number of specific pumps may trigger a low battery alarm at the beginning of the implante... Class II Codman & Shurtleff, Inc.
Nov 10, 2015 MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The Med... A small number of specific pumps may trigger a low battery alarm at the beginning of the implante... Class II Codman & Shurtleff, Inc.
Nov 10, 2015 Philips Healthcare DuraDiagnost stationary X-ray system The detector may signal that it is ready for acquisition when it actually is not, resulting in f... Class II Philips Healthcare
Nov 10, 2015 Philips Healthcare DigitalDiagnost stationary X-ray system The detector may signal that it is ready for acquisition when it actually is not, resulting in f... Class II Philips Healthcare
Nov 3, 2015 UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use... 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; 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.

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.