Browse Device Recalls
34,180 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 34,180 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 34,180 FDA device recalls — Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 21, 2025 | Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx ... | Labeling includes shelf life that has not been validated. | Class II | Folsom Metal Products, Inc. |
| Aug 21, 2025 | Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx... | Labeling includes shelf life that has not been validated. | Class II | Folsom Metal Products, Inc. |
| Aug 21, 2025 | i-STAT EG6+ cartridge. List Number: 03P77-25. | Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect upd... | Class II | Abbott Point Of Care Inc. |
| 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 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 | 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 | 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 | 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 | 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 | 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 |
| Aug 13, 2025 | Philips CT systems labeled as the following: 1. Brilliance iCT, Model Numb... | 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 | Change Healthcare Radiology Solutions software version 14.2.2 | Due to software issue, radiology reports may not be fully displayed when viewing. | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| Aug 13, 2025 | UniCel DxH 800 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 12, 2025 | NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90, REF E NR... | The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at l... | Class II | Applied Medical Technology Inc |
| Aug 12, 2025 | NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NR... | The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at l... | Class II | Applied Medical Technology Inc |
| Aug 12, 2025 | NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NR... | The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at l... | Class II | Applied Medical Technology Inc |
| Aug 12, 2025 | NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NR... | The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at l... | Class II | Applied Medical Technology Inc |
| Aug 12, 2025 | Artis Pheno. Image-Intensified Flouroscopic X-Ray System. | Limited system movements after startup . | Class II | Siemens Medical Solutions USA, Inc |
| Aug 11, 2025 | Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 1109... | Potential for falsely depressed patient, quality control (QC), and/or calibration results or dela... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 11, 2025 | Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions ... | Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schill... | Class II | Merge Healthcare, Inc. |
| Aug 11, 2025 | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... | Their is the potential for weak staining which may result in false negative CD20 identification. | Class II | Agilent Technologies Denmark ApS |
| Aug 11, 2025 | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... | Their is the potential for weak staining which may result in false negative CD20 identification. | Class II | Agilent Technologies Denmark ApS |
| Aug 11, 2025 | Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... | Their is the potential for weak staining which may result in false negative CD20 identification. | Class II | Agilent Technologies Denmark ApS |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 2023B, ... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 7, Soft... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322 | Blood collection tubes were manufactured with the label applied too high on the tube, which shif... | Class II | Greiner Bio-One North America, Inc. |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 12A, So... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 10B, So... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 6 Servi... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 9B, Sof... | DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's i... | Class II | RAYSEARCH LABORATORIES AB |
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.