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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | CS5/5+ Fastpacks, 125 mL, 20¿ Res Autotransfusion Device- Product Usage: its ... | Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1... | Class II | Haemonetics Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory compon... | Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1... | Class II | Haemonetics Corporation |
| Oct 21, 2019 | CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: it... | Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1... | Class II | Haemonetics Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory compon... | Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1... | Class II | Haemonetics Corporation |
| Oct 21, 2019 | CS5/5+ Fastpacks, 225 mL, 20¿ Res Autotransfusion Device - Product Usage: its... | Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1... | Class II | Haemonetics Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm ... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory com... | Potential to develop leaks at the inner core of Cell Saver¿ 5/5+ and Cell Saver¿ Elite¿/Elite¿ +1... | Class II | Haemonetics Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm ... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 21, 2019 | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm... | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... | Class II | Boston Scientific Corporation |
| Oct 16, 2019 | HeartStart XL+ Defibrillator/Monitor, Model 861290 | The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behav... | Class II | Philips North America, LLC |
| Oct 9, 2019 | Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower... | The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of... | Class II | Draegar Medical Systems, Inc. |
| Oct 3, 2019 | HeartStart XL+ Defibrillator/Monitor, Model 861290 | Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a... | Class II | Philips North America, LLC |
| Sep 27, 2019 | EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a ve... | On September 27, 2019 Energetiq Technology (the manufacturer) discovered a problem with their EQ... | Class II | Energetiq Technology Inc |
| Sep 18, 2019 | Manual Diff Dropper, Part Number CHB4001, used for preparing blood samples. | The metal cannula of the device either broke and the broken piece left in the blood specimen tube... | Class III | Biomedical Polymers, Inc. |
| Sep 18, 2019 | Hemo-Drop Blood Dispenser, Part Number BMP-HEMODROP, used for preparing blood... | The metal cannula of the device either broke and the broken piece left in the blood specimen tube... | Class III | Biomedical Polymers, Inc. |
| Sep 18, 2019 | iLab Polaris Multi-Modality Guidance System; iLab Ultraso... | Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batc... | Class II | Boston Scientific Corporation |
| Sep 13, 2019 | The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone... | Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose c... | Class II | Draegar Medical Systems, Inc. |
| Sep 11, 2019 | OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended f... | Stems missing porous coating on the device. | Class II | OMNIlife science Inc. |
| Sep 10, 2019 | Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revisio... | The canister neck bushing may become loose and separate from the body of the canister during use.... | Class II | Candela Corporation |
| Sep 10, 2019 | Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C ... | The canister neck bushing may become loose and separate from the body of the canister during use.... | Class II | Candela Corporation |
| Sep 10, 2019 | Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revisi... | The canister neck bushing may become loose and separate from the body of the canister during use.... | Class II | Candela Corporation |
| Sep 10, 2019 | Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C ... | The canister neck bushing may become loose and separate from the body of the canister during use.... | Class II | Candela Corporation |
| Sep 4, 2019 | lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support b... | This one pump shipped with incorrect pump programming, the initial production working version of ... | Class II | Abiomed, Inc. |
| Aug 27, 2019 | Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: ... | There is a potential patient health risk while performing chronic hemodialysis treatments in the ... | Class II | NxStage Medical, Inc. |
| Aug 23, 2019 | IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affecte... | Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some I... | Class II | Philips North America, LLC |
| Aug 22, 2019 | iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient... | Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. | Class II | Conformis, Inc. |
| Aug 22, 2019 | iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient... | Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging. | Class II | Conformis, Inc. |
| Aug 14, 2019 | Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100... | Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitig... | Class II | Siemens Healthcare Diagnostics, Inc |
| Aug 8, 2019 | FoundationOne CDx test report | Identified potential false positive MSI-H on the test reports provided to the physicians. | Class II | Foundation Medicine, Inc. |
| Jul 25, 2019 | HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03... | There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size v... | Class II | NeuroLogica Corporation |
| Jul 25, 2019 | WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19... | There is a potential for probes overheating when decreasing the Doppler SV (Sample Volume) size v... | Class II | NeuroLogica Corporation |
| Jul 24, 2019 | The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a late... | incorrect device size being listed on the impacted device packaging | Class II | LeMaitre Vascular, Inc. |
| Jul 23, 2019 | OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ... | Acetabular liners failed the oxidation testing performed prior to release. They may experience a ... | Class II | OMNIlife science Inc. |
| Jul 23, 2019 | OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ... | Acetabular liners failed the oxidation testing performed prior to release. They may experience a ... | Class II | OMNIlife science Inc. |
| Jul 23, 2019 | ROTEM ex-tem; US Part No: 503-05-US | Prolonged clotting times | Class II | Instrumentation Laboratory Co. |
| Jul 23, 2019 | ROTEM ex-tem Rest of the world part No: 503-05 (ROW) | Prolonged clotting times | Class II | Instrumentation Laboratory Co. |
| Jul 23, 2019 | ROTEM ex-tem Canada Part No: 503-05-CA | Prolonged clotting times | Class II | Instrumentation Laboratory Co. |
| Jul 23, 2019 | OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ... | Acetabular liners failed the oxidation testing performed prior to release. They may experience a ... | Class II | OMNIlife science Inc. |
| Jul 22, 2019 | Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in s... | Homocysteine Assay May Cause Elevated Results in the Folate Assay | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 22, 2019 | Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red... | Homocysteine Assay May Cause Elevated Results in the Folate Assay | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 22, 2019 | Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red b... | Homocysteine Assay May Cause Elevated Results in the Folate Assay | Class II | Siemens Healthcare Diagnostics, Inc |
| Jul 19, 2019 | Fujifilm FDR Go Plus mobile X-ray system | The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD) | Class II | Fujifilm Medical Systems U.S.A., Inc. |
| Jul 19, 2019 | AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: ... | Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore.. | Class II | Boston Scientific Corporation |
| Jul 19, 2019 | Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Produc... | The thickness of the connector to the trunk cable on affected limb lead sets may be greater than ... | Class II | Philips North America, LLC |
| Jul 16, 2019 | HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The Hea... | Non-conforming devices are identified, which may not have been included in prior field actions an... | Class II | Philips North America, LLC |
| Jul 16, 2019 | Philips Azurion systems with software version R1.2 -Interventional Fluorosc... | The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to t... | Class II | Philips North America, LLC |
| Jul 3, 2019 | DEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02 | There is a potential for "No Needle Demo Units" to contain a needle. | Class II | Valeritas, Incorporated |
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.