Browse Device Recalls
38,612 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 38,612 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 38,612 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 | Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS,... | The device does not bear a unique device identifier. | Class III | Penner Patient Care, Inc. |
| Aug 13, 2025 | Penner Pacific Bathing Spa, Model Numbers 360020-1EP | The device does not bear a unique device identifier. | Class III | Penner Patient Care, Inc. |
| 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 13, 2025 | Penner Pacific Bathing Spa, Model Numbers 360020-1P | The device does not bear a unique device identifier. | Class III | Penner Patient Care, 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 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in... | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, th... | Class I | Max Mobility LLC |
| 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 12, 2025 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in ... | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, th... | Class I | Max Mobility LLC |
| Aug 12, 2025 | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use i... | Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, th... | Class I | Max Mobility LLC |
| 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 | Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ03827... | Convenience kits labeled as sterile have not gone through the sterilization process. | Class I | Medline Industries, LP |
| 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 |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 11A, 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 | Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B | Convenience kits labeled as sterile have not gone through the sterilization process. | Class I | Medline Industries, LP |
| Aug 8, 2025 | Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.9... | Vital sign monitoring instrument may trigger an error message during blood pressures measurement... | Class II | Schiller, Ag |
| Aug 8, 2025 | IntelliSpace Cardiovascular, Software 8.0.0.4. | Software issue that results in the display of outdated information. | Class II | Philips Medical Systems Nederland B.V. |
| Aug 8, 2025 | RayStation with the following product descriptions: 1. RayStation 8B, Sof... | 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 11B, 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 | Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valve... | Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-F... | Class II | Baxter Healthcare 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.