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
Dec 30, 2019 UroDiagnost Eleva, system code 708033 A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... Class II Philips North America, LLC
Dec 30, 2019 Cardio Vascular-Allura Centron, system code 722400 A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... Class II Philips North America, LLC
Dec 30, 2019 Integris Allura 9, system codes 722018 722021 A capacitor inside the converter of the Velara X-ray generator may fail after a large number of s... Class II Philips North America, LLC
Dec 24, 2019 Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusio... A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... Class II Flowonix Medical Inc
Dec 24, 2019 Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an impla... A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... Class II Flowonix Medical Inc
Dec 24, 2019 Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantab... A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... Class II Flowonix Medical Inc
Dec 24, 2019 US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implan... A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... Class II Flowonix Medical Inc
Dec 24, 2019 Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantab... A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... Class II Flowonix Medical Inc
Dec 24, 2019 Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusio... A pump alarm function anomaly in the pump firmware code may result in the pump not sending the ex... Class II Flowonix Medical Inc
Dec 23, 2019 VesselNavigator application used with Philips Azurion (Azurion 7 Series) Soft... Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselN... Class II Philips North America, LLC
Dec 17, 2019 AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Prod... A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with Inhib... Class II Boston Scientific Corporation
Dec 2, 2019 PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006 The boxes used by the shipper were not validated for use during transport. Class II 3-D Matrix, Inc.
Nov 20, 2019 ProxiDiagnost N90 Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose. Class II Philips North America, LLC
Nov 18, 2019 Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product... During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the... Class II Boston Scientific Corporation
Nov 18, 2019 Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product... During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the... Class II Boston Scientific Corporation
Nov 15, 2019 O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000 Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determ... Class II Medtronic Navigation, Inc.-Littleton
Nov 8, 2019 AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H ... Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's ... Class II Boston Scientific Corporation
Nov 4, 2019 Healix Knotless ADV BR 5.5 Suture Anchor Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured w... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 4, 2019 Healix Knotless ADV BR 4.75 Suture Anchor Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured w... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Oct 29, 2019 HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 170... Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia) Class II Bio-Signal Group Corp.
Oct 29, 2019 HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconduct... Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia) Class II Bio-Signal Group Corp.
Oct 28, 2019 Genius 2 Tympanic Thermometer OEM Tympanic Item Code: 303063 The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... Class II Cardinal Health 200, LLC
Oct 28, 2019 Genius 3 Tympanic Thermometer- electric thermometer Item Code: 303013 The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... Class II Cardinal Health 200, LLC
Oct 28, 2019 Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000 The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... Class II Cardinal Health 200, LLC
Oct 28, 2019 Genius 2 Tympanic Thermometer Private Label Item Code: 3069 The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... Class II Cardinal Health 200, LLC
Oct 28, 2019 Genius 2 Tympanic Thermometer OEM Tympanic Item Code:303062 The frequency of calibration for the Genius Tympanic Thermometer as stated in the operating manua... Class II Cardinal Health 200, LLC
Oct 25, 2019 iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Produc... Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant. Class II Conformis, Inc.
Oct 21, 2019 JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its related accessory c... 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 JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory c... 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 JAPAN CELL SAVER ELITE SET - 125ML - 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 High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product Usage: i... 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 Processing Set (125 ml) Autotransfusion Device - Product Usage:its r... 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, 125 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 Japan DISP SET, 263J, 205J, 208 - 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 JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory compone... 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, 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 8cm ... 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+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related ac... 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 7cm ... Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... Class II Boston Scientific Corporation
Oct 21, 2019 CS Elite Fastpack, 225 mL, 20¿ 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 Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640 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 11cm... Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... Class II Boston Scientific Corporation
Oct 21, 2019 CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its r... 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 Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related access... 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 JAPAN DISP SET, 261J, 205J, 208 - 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 Cell Saver¿5/5+ Bowl Kit (225 ml) 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 CS Elite Fastpack, 125 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 18cm... 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 3cm... 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 Advanix Pancreatic Stent, Straight Leading Barb, 10F x 4cm UPN: M00... Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 3... Class II Boston Scientific Corporation

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.