Browse Device Recalls

39,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,969 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 39,969 FDA device recalls.

DateProductReasonClassFirm
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
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 20CM 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, 23CM SM 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 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, 20CM 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, 23CM 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 Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural... Infusion Pumps with affected software revision may fail to detect air in line, which may lead to ... Class I EITAN MEDICAL LTD
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 20CM 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 SM 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 GS0008 2Y - Burn Pack - STL, Item Number 880082025 Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 ... Class II ROi CPS LLC
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 18CM 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 SM 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 8, 2023 Centricity Universal Viewer Workflow Manager, Image processing radiological s... When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a thir... Class II GE Healthcare
Sep 8, 2023 Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-... An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower b... Class II Omega Medical Imaging, Inc.
Sep 8, 2023 F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) There is a potential interruption of data communication between E-modules inserted in the F2-01 F... Class II GE Medical Systems China Co., Ltd.
Sep 8, 2023 Universal Viewer Workflow Manager, Image processing radiological system When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a thir... Class II GE Healthcare
Sep 7, 2023 Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARAC... Custom surgical procedure packs contain latex gloves but are labeled as "latex free". Class II Alcon Research, LLC
Sep 7, 2023 Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software ve... CORI software was missing a planning stage that appears in cases of significant knee deformation ... Class II Blue Belt Technologies, Inc
Sep 7, 2023 Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 Inadvertent release of embolectomy catheters that may experience slower than normal balloon defla... Class II Edwards Lifesciences, LLC
Sep 6, 2023 2008T HD SYS. CDX BLUESTAR Potential PCBA leaching from tubing of hemodialysis machines. Class I Fresenius Medical Care Holdings, Inc.
Sep 6, 2023 Meera Mobile Operating Table-to support and position the patient immediately ... Under certain conditions, an issue might prevent the device from performing as intended. A specif... Class II Getinge Usa Sales Inc
Sep 6, 2023 BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wi... When global edit is used to update multiple formulary properties simultaneously, the following pr... Class II CareFusion 303, Inc.
Sep 6, 2023 RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (... RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not mee... Class II Randox Laboratories Ltd.
Sep 6, 2023 AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solu... The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU)... Class II Beckman Coulter Biomedical Division
Sep 6, 2023 2008T Hemodialysis System without CDX Potential PCBA leaching from tubing of hemodialysis machines. Class I Fresenius Medical Care Holdings, Inc.

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.