Browse Device Recalls

39,949 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,949 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 39,949 FDA device recalls.

DateProductReasonClassFirm
Sep 22, 2025 Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (S... The potential for falsely depressed Intact PTH patient results at the low end of the assay range,... Class II Siemens Healthcare Diagnostics, Inc.
Sep 22, 2025 DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 T... Due to a software error code that crashes during acquisition on patient sample when running custo... Class II Beckman Coulter Inc.
Sep 19, 2025 DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part N... Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the ... Class II Beckman Coulter, Inc.
Sep 19, 2025 Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation S... Polyaxial screws do not meet performance standards. Class II Orthofix U.S. LLC
Sep 19, 2025 DxI 9000 Access Immunoassay Analyzer, Part Number C11137 Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the ... Class II Beckman Coulter, Inc.
Sep 19, 2025 Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27... Complaint identified issue with AI surgical planning software that may result in implant malalig... Class II Kico Knee Innovation Company
Sep 18, 2025 Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stoma... Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... Class II Cardinal Health 200, LLC
Sep 18, 2025 PERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle ... Potential for the lid of the catheter connector to be in the incorrect position. Class II B BRAUN MEDICAL INC
Sep 18, 2025 HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-P... Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanic... Class II HeartSine Technologies Ltd
Sep 18, 2025 PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in... Potential for the lid of the catheter connector to be in the incorrect position. Class II B BRAUN MEDICAL INC
Sep 18, 2025 LOGIQ P10 series with software version R4.5.7 Model Number 5877534 The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values... Class II GE Medical Systems, LLC
Sep 18, 2025 PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) T... Potential for the lid of the catheter connector to be in the incorrect position. Class II B BRAUN MEDICAL INC
Sep 18, 2025 PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8... Potential for the lid of the catheter connector to be in the incorrect position. Class II B BRAUN MEDICAL INC
Sep 18, 2025 Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SAL... Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... Class II Cardinal Health 200, LLC
Sep 18, 2025 Design Options, Pain Management Tray. Product Code: SESK. Product Description... Potential for the lid of the catheter connector to be in the incorrect position. Class II B BRAUN MEDICAL INC
Sep 18, 2025 PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8... Potential for the lid of the catheter connector to be in the incorrect position. Class II B BRAUN MEDICAL INC
Sep 18, 2025 LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model N... The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values... Class II GE Medical Systems, LLC
Sep 18, 2025 Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Prod... Potential for the lid of the catheter connector to be in the incorrect position. Class II B BRAUN MEDICAL INC
Sep 18, 2025 Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Ki... When unintentionally disconnected from power source, humidifier device (used to deliver high flow... Class II Fisher & Paykel Healthcare, Ltd.
Sep 18, 2025 Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Cat... Software issue for hq analyzer results in system not visibly applying appropriate flagging to res... Class II Abbott Laboratories
Sep 18, 2025 PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in... Potential for the lid of the catheter connector to be in the incorrect position. Class II B BRAUN MEDICAL INC
Sep 18, 2025 Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference... Affected devices may contain PTFE coating scrapings. Scrapings could be released during device de... Class I Cook Medical Incorporated
Sep 18, 2025 Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-... Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... Class II Cardinal Health 200, LLC
Sep 18, 2025 ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 ... Potential for the lid of the catheter connector to be in the incorrect position. Class II B BRAUN MEDICAL INC
Sep 18, 2025 PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in... Potential for the lid of the catheter connector to be in the incorrect position. Class II B BRAUN MEDICAL INC
Sep 18, 2025 Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9... Potential for the lid of the catheter connector to be in the incorrect position. Class II B BRAUN MEDICAL INC
Sep 18, 2025 Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8... Potential for the lid of the catheter connector to be in the incorrect position. Class II B BRAUN MEDICAL INC
Sep 18, 2025 Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" P... Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... Class II Cardinal Health 200, LLC
Sep 18, 2025 Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stoma... Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... Class II Cardinal Health 200, LLC
Sep 18, 2025 PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in... Potential for the lid of the catheter connector to be in the incorrect position. Class II B BRAUN MEDICAL INC
Sep 18, 2025 LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Mod... The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values... Class II GE Medical Systems, LLC
Sep 18, 2025 Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Si... Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... Class II Cardinal Health 200, LLC
Sep 17, 2025 SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL... Class II Beckman Coulter Inc.
Sep 17, 2025 MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.... When appending a care plan that contains one or more wave medication orders, the occurrence and ... Class II ELEKTA SOLUTIONS AB
Sep 17, 2025 InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE PO... InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in f... Class II Enterix, Inc.
Sep 17, 2025 Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: ... IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't us... Class I Percussionaire Corporation
Sep 17, 2025 Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS2... Instructions for use for a foot plating system is being updated to remove the second option of re... Class II CPM Medical Consultants, LLC.
Sep 17, 2025 Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp... Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. ... Class II Baxter Healthcare Corporation
Sep 16, 2025 Catalyft PL & PL40 Expandable Interbody System labeled as follows with corres... Expandable interbody system cage may loose height or collapse (loss of lordosis), which could res... Class II Medtronic Sofamor Danek USA Inc
Sep 16, 2025 SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP)... A software anomaly, under specific conditions when large rotational alignment values are applied ... Class II Surgical Theater Inc
Sep 16, 2025 Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 9... Due to two distinct issues: 1. During patient admission, patient demographic fields may default ... Class II Spacelabs Healthcare, Ltd.
Sep 16, 2025 Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software ... A software anomaly, under specific conditions when large rotational alignment values are applied ... Class II Surgical Theater Inc
Sep 16, 2025 Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, im... A software anomaly, under specific conditions when large rotational alignment values are applied ... Class II Surgical Theater Inc
Sep 16, 2025 Automated Impella Controller (AIC) labeled as the following with correspondin... Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer fail... Class I Abiomed, Inc.
Sep 16, 2025 SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP... A software anomaly, under specific conditions when large rotational alignment values are applied ... Class II Surgical Theater Inc
Sep 16, 2025 Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), sof... A software anomaly, under specific conditions when large rotational alignment values are applied ... Class II Surgical Theater Inc
Sep 16, 2025 Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmente... A software anomaly, under specific conditions when large rotational alignment values are applied ... Class II Surgical Theater Inc
Sep 16, 2025 SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radio... A software anomaly, under specific conditions when large rotational alignment values are applied ... Class II Surgical Theater Inc
Sep 15, 2025 FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566... It was found that the shaft for mounting the X-ray tube unit on the support may break. In additio... Class II FUJIFILM Healthcare Americas Corporation
Sep 15, 2025 CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: ... XXX Class II Alcon Research 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.