Browse Device Recalls
3,089 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,089 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 3,089 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: ... | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Class II | DJO, LLC |
| Mar 19, 2026 | Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Nu... | Due to broken connector which may result in a temporary interruption of prescribed cold therapy. | Class II | DJO, LLC |
| Mar 19, 2026 | Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Car... | Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE"... | Class I | Boston Scientific Corporation |
| Mar 19, 2026 | Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VA... | Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE"... | Class I | Boston Scientific Corporation |
| Mar 19, 2026 | Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software me... | Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (I... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Mar 12, 2026 | iLet Bionic Pancreas, REF: BB1001 | insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring ... | Class II | Beta Bionics, Inc. |
| Mar 7, 2026 | Philips Spectral CT on Rails. Model Number: 728334. | Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the... | Class II | PHILIPS MEDICAL SYSTEMS |
| Mar 6, 2026 | CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical ... | Software issue that renders the touch screen unresponsive. | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Mar 4, 2026 | Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2... | Product labeling includes a fetal indication for use that is not cleared under its 510(k). | Class II | Koven Technology, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous ho... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Conti... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous h... | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the r... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home... | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous h... | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous ho... | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| Mar 2, 2026 | Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Conti... | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy ... | Class I | Philips Respironics, Inc. |
| Feb 20, 2026 | Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL... | Due to a quality issue regarding the presence of burr on the finished cervical plate product. | Class II | Clariance-SAS |
| Feb 19, 2026 | Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Produ... | Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to... | Class II | AMO Puerto Rico Manufacturing, Inc. |
| Feb 18, 2026 | Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener... | Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights... | Class II | Baxter Healthcare Corporation |
| Feb 9, 2026 | RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 | Due to a radiotherapy medical system software defect, when performing angular roll corrections fo... | Class II | Reflexion Medical, Inc. |
| Feb 9, 2026 | Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Softw... | It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to ... | Class II | Abbott Diagnostics Scarborough, Inc. |
| Feb 6, 2026 | Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR | Software anomaly in the patient positioning system may result in positional discrepancy. | Class II | Hitachi, Ltd. Radiation Oncology Systems, Kashi... |
| Feb 6, 2026 | Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR | Software anomaly in the patient positioning system may result in positional discrepancy. | Class II | Hitachi, Ltd. Radiation Oncology Systems, Kashi... |
| Feb 2, 2026 | Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Mod... | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | B Braun Medical Inc |
| Feb 2, 2026 | Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Ca... | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | B Braun Medical Inc |
| Feb 2, 2026 | Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number... | The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. | Class II | B Braun Medical Inc |
| Jan 30, 2026 | Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a devi... | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers... | Class II | GE Medical Systems, LLC |
| Jan 30, 2026 | Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a... | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers... | Class II | GE Medical Systems, LLC |
| Jan 30, 2026 | MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and ... | Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that ... | Class II | Medtronic MiniMed, Inc. |
| Jan 30, 2026 | Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a dev... | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Univers... | Class II | GE Medical Systems, LLC |
| Jan 30, 2026 | HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: ... | Due to complaints and investigations stating that alarms from the primary patient bedside monitor... | Class II | Covidien LLC |
| Jan 30, 2026 | DxC 700 AU, REF: B86444, B86446 | A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC instal... | Class II | Beckman Coulter Mishima K.K. |
| Jan 30, 2026 | CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 | A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC instal... | Class II | Beckman Coulter Mishima K.K. |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TR... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SP... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOS... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 200... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRA... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 29, 2026 | Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model... | B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL... | Class II | B Braun Medical Inc |
| Jan 26, 2026 | Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Softwa... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Sof... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)7... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version ... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Soft... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)7222... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 26, 2026 | Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Softwa... | Under certain conditions, the table may move unexpectedly when the Reset Geometry button is press... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
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.