Browse Device Recalls
2,601 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,601 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 2,601 FDA device recalls in 2023.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 21, 2023 | DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display a... | Potential for units suspended on the ceiling to fail and fall. | Class II | Philips North America Llc |
| Sep 20, 2023 | Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack | Demonstrated recognition and compatibility issues with syringe infusion pumps. | Class I | Cardinal Health 200, LLC |
| Sep 20, 2023 | Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack | Demonstrated recognition and compatibility issues with syringe infusion pumps. | Class I | Cardinal Health 200, LLC |
| Sep 20, 2023 | Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack | Demonstrated recognition and compatibility issues with syringe infusion pumps. | Class I | Cardinal Health 200, LLC |
| Sep 20, 2023 | Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack | Demonstrated recognition and compatibility issues with syringe infusion pumps. | Class I | Cardinal Health 200, LLC |
| Sep 20, 2023 | Monoject 20 mL Syringe Luer-Lock Tip Soft Pack | Demonstrated recognition and compatibility issues with syringe infusion pumps. | Class I | Cardinal Health 200, LLC |
| Sep 20, 2023 | Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack | Demonstrated recognition and compatibility issues with syringe infusion pumps. | Class I | Cardinal Health 200, LLC |
| Sep 19, 2023 | Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 pri... | Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different... | Class II | Maquet Cardiovascular, LLC |
| Sep 19, 2023 | LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test ki... | During an internal audit a small percentage (<10%) of plastic caps used to close the treatment re... | Class II | Magellan Diagnostics, Inc. |
| Sep 19, 2023 | NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pi... | Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuat... | Class II | NeuroSync, Inc. |
| Sep 18, 2023 | IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions wit... | The patient positioning system can perform motions in unexpected directions, creating the potenti... | Class II | Ion Beam Applications S.A. |
| Sep 18, 2023 | DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit | DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Me... | Class II | DeRoyal Industries Inc |
| Sep 18, 2023 | Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS ... | Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide s... | Class II | Atrium Medical Corporation |
| Sep 18, 2023 | Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blo... | Potential risk of reporting erroneous creatinine patient results associated with the initial star... | Class II | Nova Biomedical Corporation |
| Sep 18, 2023 | Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1... | Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide s... | Class II | Atrium Medical Corporation |
| Sep 18, 2023 | Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain ga... | Potential risk of reporting erroneous creatinine patient results associated with the initial star... | Class II | Nova Biomedical Corporation |
| Sep 18, 2023 | Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE;... | Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide s... | Class II | Atrium Medical Corporation |
| Sep 15, 2023 | BD Alaris PCU REF 8015 | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ... | Class I | CareFusion 303, Inc. |
| Sep 15, 2023 | stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25m... | One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured ... | Class II | Tornier, Inc |
| Sep 15, 2023 | BD Alaris Syringe Module, REF 8110 | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ... | Class I | CareFusion 303, Inc. |
| Sep 15, 2023 | Alaris PCA Module 8120 | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ... | Class I | CareFusion 303, Inc. |
| Sep 15, 2023 | Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ... | Asensus Surgical has identified a malfunction that has occurred and may recur on the Senhance Sur... | Class I | Asensus Surgical Inc |
| Sep 14, 2023 | Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW... | Use of assay along with plasma specimen may result in error code which would invalidate sample. | Class II | Hologic, Inc. |
| Sep 14, 2023 | Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiologica... | GE HealthCare has become aware of an issue where images from two different patients may be contai... | Class II | GE Healthcare |
| Sep 14, 2023 | Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Rad... | GE HealthCare has become aware of an issue where images from two different patients may be contai... | Class II | GE Healthcare |
| Sep 14, 2023 | EVIS EXERA III Video System Center Model Number CV-190. Intended to be used w... | Certain serial numbers of the CV-190 do not start up properly because parts that deviated from th... | Class II | Olympus Corporation of the Americas |
| Sep 14, 2023 | Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW found... | GE HealthCare has become aware of an issue where images from two different patients may be contai... | Class II | GE Healthcare |
| Sep 13, 2023 | BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walkin... | Due to walkers not meeting product specifications. Walkers were manufactured with misaligned whe... | Class II | Breg Inc |
| Sep 13, 2023 | Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposa... | Expired product distributed | Class II | Stryker Corporation |
| Sep 13, 2023 | Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Pr... | Syringe contains conical tip that is not compatible with certain needleless IV connector(s). | Class II | Cardinal Health 200, LLC |
| Sep 13, 2023 | Astral 100 and Astral 150 ventilators | If ventilator is on internal battery, not intended to serve as a primary power source, low/critic... | Class I | ResMed Ltd. |
| Sep 13, 2023 | Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance... | Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epi... | Class II | Maquet Cardiovascular, LLC |
| Sep 12, 2023 | BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023 | Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicat... | Class II | Becton Dickinson & Co. |
| Sep 12, 2023 | THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indica... | Thunderbeats blue seal button may remain in the engaged position after the button is released and... | Class II | Olympus Corporation of the Americas |
| Sep 12, 2023 | RayCare 5B and 6A including service packs- An oncology information system use... | An issue was found in RayCare 5B, 6A, including service packs, where values will not be visible f... | Class II | RAYSEARCH LABORATORIES AB |
| Sep 12, 2023 | DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and b... | The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information... | Class II | Beckman Coulter, Inc. |
| Sep 12, 2023 | THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indic... | Thunderbeats blue seal button may remain in the engaged position after the button is released and... | Class II | Olympus Corporation of the Americas |
| Sep 12, 2023 | Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed fo... | Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirem... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 12, 2023 | VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 S... | Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cau... | Class II | Ortho-Clinical Diagnostics, INc. |
| Sep 12, 2023 | ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray Sy... | Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirem... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catal... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catal... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catal... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Ca... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Ca... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Ca... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Ca... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catal... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Ca... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Ca... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker 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.