Browse Device Recalls
2,831 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,831 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 2,831 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 20, 2025 | Model Number L110, ESSENTIO SR SL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | ACCOLADE DR EL MRI (Model L331) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L131, ESSENTIO DR EL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number U228, VISIONIST CRT-P EL MRI | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L101, ESSENTIO DR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L231, PROPONENT DR EL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number U128, VALITUDE CRT-P EL MRI | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L211 PROPONENT DR SL MRI Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L121 ESSENTIO DR EL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used wit... | An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs con... | Class II | MicroSurgical Technology Inc |
| Aug 20, 2025 | Model Number L221 PROPONENT DR EL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | PROPONENT SR SL (Model L200) | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number U226, VISIONIST CRT-P EL | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Model Number L209 PROPONENT DR (VDD) SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 20, 2025 | Automated Impella Controller (AIC) with the below brands and product codes. U... | Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not mee... | Class I | Abiomed, Inc. |
| Aug 20, 2025 | Model Number S702, ALTRUA 2 DR SL Pacemaker | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... | Class I | Boston Scientific Corporation |
| Aug 19, 2025 | Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator ... | Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel sepa... | Class II | Greiner Bio-One North America, Inc. |
| Aug 18, 2025 | AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R. | Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAG... | Class II | Aesculap AG |
| Aug 18, 2025 | EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.... | Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposu... | Class II | CORNEAT VISION, LTD. |
| Aug 18, 2025 | Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000 | Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. | Class II | Boston Scientific Corporation |
| Aug 18, 2025 | CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix... | Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposu... | Class II | CORNEAT VISION, LTD. |
| Aug 18, 2025 | AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R. | Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAG... | Class II | Aesculap AG |
| Aug 18, 2025 | ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Ma... | Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. | Class II | Boston Scientific Corporation |
| Aug 15, 2025 | Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occlu... | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the... | Class II | Maquet Cardiovascular, LLC |
| Aug 15, 2025 | Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG ... | Reverse Shoulder humeral liners have an articular surface position outside of the dimensional spe... | Class II | Exactech, Inc. |
| Aug 15, 2025 | STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX S... | Potential for barb non-engagement. | Class II | ETHICON, LLC |
| Aug 15, 2025 | BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA0001... | Potential for activation of an abnormal alarm pause. | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Aug 15, 2025 | Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occlu... | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the... | Class II | Maquet Cardiovascular, LLC |
| Aug 15, 2025 | Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 3... | Reverse Shoulder humeral liners have an articular surface position outside of the dimensional spe... | Class II | Exactech, Inc. |
| Aug 15, 2025 | Heartstring III Proximal Seal System. Intravascular anastomosis occluder. | Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the... | Class II | Maquet Cardiovascular, LLC |
| Aug 13, 2025 | iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software | it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcod... | Class II | Beta Bionics, Inc. |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model N... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2 | The device does not bear a unique device identifier. | Class III | Penner Patient Care, Inc. |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite ... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X | The device does not bear a unique device identifier. | Class III | Penner Patient Care, Inc. |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB ... | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (H... | Class II | Beckman Coulter Inc. |
| Aug 13, 2025 | Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 56... | The device does not bear a unique device identifier. | Class III | Penner Patient Care, Inc. |
| Aug 13, 2025 | Penner Pacific Bathing Spa, Model Numbers 860010-1L | The device does not bear a unique device identifier. | Class III | Penner Patient Care, Inc. |
| Aug 13, 2025 | Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 36... | The device does not bear a unique device identifier. | Class III | Penner Patient Care, Inc. |
| Aug 13, 2025 | Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 36... | The device does not bear a unique device identifier. | Class III | Penner Patient Care, Inc. |
| Aug 13, 2025 | UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB... | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (H... | Class II | Beckman Coulter Inc. |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, ... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1 | The device does not bear a unique device identifier. | Class III | Penner Patient Care, Inc. |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB ... | Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (H... | Class II | Beckman Coulter Inc. |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Big Bore RT, Model Number:... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Nu... | The patient support table (couch) may descend unexpectedly to the lowermost position due to a com... | Class II | Philips North America Llc |
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.