Browse Device Recalls
2,817 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,817 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 2,817 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 23, 2025 | BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Numbe... | There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint... | Class II | Biomet, Inc. |
| Sep 23, 2025 | BD BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX,... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| Sep 23, 2025 | BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), C... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| Sep 23, 2025 | Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klass... | Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... | Class II | Total Joint Orthopedics, Inc. |
| Sep 23, 2025 | BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 S... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| Sep 23, 2025 | BD EpiCenter Microbiology Data Management System, labeled as the following: ... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| 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. |
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.