Browse Device Recalls
38,509 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 38,509 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 38,509 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Sodium Fl... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Balanced... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | CODMAN Disposable Perforator 11mm. Cranial Perforator. | Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 m... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| Sep 26, 2025 | SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 ¿L; Prepared with Sodium H... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batt... | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected bat... | Class II | GE Healthcare Finland Oy |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Acti... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings ... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L; Prepared with Lithium H... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Acti... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 26, 2025 | SAFE-T-FILL End Caps for SAFE-T-FILL Blood Gas Capillaries; Fits outer diamet... | Due to products manufactured under an inadequate quality system to include unvalidated manufactur... | Class II | ASP Global, LLC. dba Anatomy Supply Partners, LLC. |
| Sep 25, 2025 | Artegraft¿ Collagen Vascular Graft; REF: AG1015; | The device was incorrectly packed in the wrong size labeled outer packaging. | Class II | LeMaitre Vascular, Inc. |
| Sep 25, 2025 | Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02 | The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression... | Class II | DJO, LLC |
| Sep 25, 2025 | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/... | A manufacturing issue could lead to a malformed cover tube press which can lead to internal compo... | Class II | Covidien, LP |
| Sep 25, 2025 | Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Ve... | Issue 1: The potential for unintentional continued gantry/couch movement when a specific button s... | Class II | PHILIPS MEDICAL SYSTEMS |
| Sep 25, 2025 | Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast ... | Due to an identified manufacturing defect involving coating material lifting within the catheter'... | Class I | BALT USA, LLC |
| Sep 25, 2025 | Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.... | Issue 1: The potential for unintentional continued gantry/couch movement when a specific button s... | Class II | PHILIPS MEDICAL SYSTEMS |
| Sep 25, 2025 | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/... | A manufacturing issue could lead to a malformed cover tube press which can lead to internal compo... | Class II | Covidien, LP |
| Sep 25, 2025 | Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Ver... | Issue 1: The potential for unintentional continued gantry/couch movement when a specific button s... | Class II | PHILIPS MEDICAL SYSTEMS |
| Sep 24, 2025 | HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F,... | Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting i... | Class II | Stryker Sustainability Solutions |
| Sep 24, 2025 | Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/C... | It was determined there is the potential of silicone fragments detaching from the yellow sealing ... | Class II | Aesculap Inc |
| Sep 24, 2025 | Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Ca... | It was determined there is the potential of silicone fragments detaching from the yellow sealing ... | Class II | Aesculap Inc |
| Sep 24, 2025 | Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/... | It was determined there is the potential of silicone fragments detaching from the yellow sealing ... | Class II | Aesculap Inc |
| Sep 24, 2025 | Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER ... | It was determined there is the potential of silicone fragments detaching from the yellow sealing ... | Class II | Aesculap Inc |
| Sep 23, 2025 | BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Aut... | Product service credentials used by some BD technical support teams to access certain BD products... | Class II | Becton Dickinson & Co. |
| Sep 23, 2025 | BD MAX System, for in vitro diagnostic (IVD) use, 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 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. |
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.