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 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 |
| 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. |
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.